Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H150181 | Other Identifier | VA HRPP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with impairment in functioning across a host of psychosocial domains including occupational and academic functioning, marital and family functioning, parenting, and socialization. Impairment is not limited to Veterans with PTSD because the entire family is affected, particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on both members of the dyad. Despite the need for treatment, many Veterans and their families do not access PTSD-related services due to a number of barriers to accessing care (e.g., living in rural or remote areas where no specialty services exist, concerns about stigma around using mental health services, limited clinic hours to accommodate patient schedules). The objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy, in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and their romantic partners in their homes via clinical video teleconferencing leads to better outcomes compared to office based treatment.
Anticipated Impact on Veterans' Healthcare: This project addresses the mental health and functioning needs of Veterans and their families by increasing the access to an established treatment using telemental health technology.
Project Background: Veterans and their families experience the deleterious effects of posttraumatic stress disorder (PTSD) and associated negative sequelae. PTSD is related to a variety of comorbid mental health symptomatology and psychosocial impairment, including high rates of intimate relationship problems which impact Veterans' recovery and functioning. Despite available couple-based interventions, barriers to care such as stigma regarding mental health treatment, travel time to receive care, and transportation costs, make it difficult for Veterans and their families to access specialty PTSD treatments necessary for rehabilitation. Home-based clinical video teleconferencing (CVT) delivers specialized mental health treatments to clients in the ease of their own home, which allows clinicians to directly observe the client's home environment and family milieu. Cognitive-Behavioral Conjoint Therapy (CBCT), a couple-based treatment designed to target PTSD symptoms and improve individual and relationship functioning, has shown evidence of improvements in clinical symptom outcomes in research conducted with Veterans and their partners.
Project Objectives: This is a 4-year randomized controlled trial. The primary objective of this study is to compare the clinical efficacy (PTSD symptoms, relationship distress, and functional impairment) of CBCT delivered via an office-based (CBCT-OB) or a home-based CVT (CBCT-HB) delivery modality to the PTSD Family Education control condition (PFE). In addition, this study will estimate and compare the difference in clinical efficacy between CBCT delivered via an office-based (CBCT-OB) or a home-based CVT (CBCT-HB) delivery modality if indicated by results of the primary objective. This study will also compare process outcomes (therapeutic alliance, enrollment and dropout rates, and treatment satisfaction) for CBCT-OB, CBCT-HB, and PFE.
Project Methods: Participants will be 180 intent-to-treat couples in which one partner is a PTSD-positive Veteran. Couples will be randomly assigned to receive treatment through one of the three treatment delivery modalities: CBCT-OB, CBCT-HB or PFE. Assessments will be conducted at baseline, mid- and post-treatment, and 3- and 6-months post-treatment. The primary outcome variables of clinical efficacy will be measures of PTSD symptom severity, relationship distress, and functional impairment. Secondary outcome variables include PTSD diagnostic status, self- reported PTSD symptoms, depression, anger, and relationship conflict. Additionally, primary process outcomes will include measures of treatment retention, attendance, therapeutic alliance, and treatment satisfaction. Variability in scores for each of the primary and secondary outcome measures will be examined individually in a series of separate multilevel models. The results will provide evidence that can be used to further increase the clinical efficacy, ease of access to, and utilization of specialty PTSD treatment to Veterans and their families.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBCT-Home Based (CBCT-HB) | Experimental | Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). |
|
| CBCT-Office Based (CBCT-OB) | Active Comparator | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. |
|
| PTSD Family Education (PFE) | Active Comparator | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCT-Home Based (CBCT-HB) | Behavioral | Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | Baseline |
| Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | 1 Month Post Treatment |
| Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | 3-Months Post Treatment |
| Clinician Administered PTSD Scale (CAPS) |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Baseline |
| PTSD Checklist-5 (PCL-5) |
Not provided
Inclusion Criteria:
Be a Veteran (age 18 or older) with a current Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of PTSD (as assessed by the CAPS) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
Be on a stable psychoactive medication regimen for at least 2 months (if eligible)
Be an intimate partner (age 18 or older) who is willing to participate in the intervention.
Be randomized into any of the three treatment conditions
Have assessment and treatment sessions audio recorded
Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study
Consistent with home-based clinical trials and actual clinical practice
Participants enrolled into the study will need to have access to internet via Digital Subscriber Line (DSL) or a cable provider in case they are randomized into the home-based condition.
Exclusion Criteria:
Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)108 and Drug Abuse Screening Test (DAST)
Any current uncontrolled psychotic disorder in either member of the couple
Imminent suicidality or homicidality in either member of the couple
Any severe cognitive impairment in either member of the couple
Any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the Conflict Tactics Scale-2 [CTS-2]).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leslie A. Morland, PsyD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35604746 | Derived | Morland LA, Knopp KC, Khalifian CE, Macdonald A, Grubbs KM, Mackintosh MA, Becker-Cretu JJ, Sautter FJ, Buzzella BA, Wrape ER, Glassman LH, Webster K, Sohn MJ, Glynn SM, Acierno R, Monson CM. A randomized trial of brief couple therapy for PTSD and relationship satisfaction. J Consult Clin Psychol. 2022 May;90(5):392-404. doi: 10.1037/ccp0000731. | |
| 35084882 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
During the recruitment period from October 2016 to March 2020, we received 706 referrals from the myriad of community-based outpatient clinics (CBOCs; e.g., VA Mission Valley Clinic), VA associated clinics (e.g., Family Mental Health), and self-referrals, typically from Veterans who see our study ads (both virtual and physical) in the La Jolla VA Main Hospital.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CBCT-Home Based (CBCT-HB) | Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). |
| FG001 | CBCT-Office Based (CBCT-OB) | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. |
| FG002 | PTSD Family Education (PFE) | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CBCT-Home Based (CBCT-HB) | Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Baseline |
|
The adverse event data were collected for up to 1 year since the date of baseline.
Clinicaltrials.gov definition is consistent with definition used for the duration of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBCT-Home Based (CBCT-HB) | Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). CBCT-Home Based (CBCT-HB): Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit | General disorders | Non-systematic Assessment | Unrelated to study. Same-day discharge from ER. |
Study exclusion criteria (e.g., recent aggression, suicidality) may have excluded couples with more severe pathology. All measures except for the CAPS-5 were self-reported measures, introducing potential bias in reporting. This study involved significant administrative support for telehealth procedures; not all VA clinical settings will include these administrative supports, which may reduce generalizability of our results to standard clinical care.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie A. Morland | VHASDC | 858-552-4324 | Leslie.Morland@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2021 | Sep 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2021 | Sep 29, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Study assessors are kept blind to the couple's randomly assigned treatment condition.
|
| CBCT-Office Based (CBCT-OB) | Behavioral | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. |
|
| PTSD Family Education (PFE) | Behavioral | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. |
|
The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.
*Score range: 0-80 with higher score indicating greater symptom severity
| 6- Months Post Treatment |
| Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Baseline |
| Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Mid Treatment (Approximately week 5 of all treatment conditions) |
| Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | 1 Month Post Treatment |
| Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | 3- Months Post Treatment |
| Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | 6- Months Post Treatment |
| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Baseline |
| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Mid Treatment (Approximately week 5 of all treatment conditions) |
| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | 1 Month Post Treatment |
| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | 3- Months Post Treatment |
| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | 6- Months Post Treatment |
| Client Satisfaction Questionnaire (CSQ) | Client Satisfaction Questionnaire (CSQ) is an 8-item measure about satisfaction with treatment rated on a 4-point Likert scale. Higher mean scores (range 0 to 4) represent higher satisfaction with treatment services. | 1 Month Post Treatment |
| Working Alliance Inventory- Short Form (WAI-S) | This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance. | Approximately week 3 of all treatment conditions |
| Working Alliance Inventory- Short Form (WAI-S) | This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance. | Approximately week 8 of all treatment conditions |
The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms.
| Mid Treatment (Approximately week 5 of all treatment conditions) |
| PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | 1 Month Post Treatment |
| PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | 3- Months Post Treatment |
| PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | 6-Months Post Treatment |
| Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Baseline |
| Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Mid Treatment (Approximately Week 5 of all treatment conditions) |
| Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | 1 Month Post Treatment |
| Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | 3- Months Post Treatment |
| Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | 6-Months Post Treatment |
| State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Baseline |
| State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Mid Treatment (Approximately week 5 of all treatment conditions) |
| State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | 1 Month Post Treatment |
| State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | 3- Months Post Treatment |
| State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | 6-Months Post Treatment |
| Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Baseline |
| Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Mid Treatment (Approximately week 5 of all treatment conditions) |
| Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | 1 Month Post Treatment |
| Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | 3- Months Post Treatment |
| Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | 6-Months Post Treatment |
| Khalifian CE, Bosch J, Knopp K, Delay C, Sohn MJ, Morland LA. Adverse childhood experiences, mental health, and relationship satisfaction in military couples. J Fam Psychol. 2022 Jun;36(4):630-635. doi: 10.1037/fam0000952. Epub 2022 Jan 27. |
| Scheduling issues |
|
| Childcare |
|
| Withdrawal by PI |
|
| Moved away |
|
| Not Primary Health Concern |
|
| Transportation issues |
|
| Other |
|
| BG001 | CBCT-Office Based (CBCT-OB) | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. |
| BG002 | PTSD Family Education (PFE) | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| CAPS-5 | Clinician-Administered PTSD Scale (CAPS-5) for Diagnostic and Statistical Manual-5 (DSM-5) is a 30-item structured diagnostic interview that is considered the gold standard in PTSD assessment. It is designed to make a categorical PTSD diagnosis and provide measure of symptom severity. The structure corresponds to the DSM-5 criteria and can be administered by clinicians, clinical researchers, or appropriately trained paraprofessionals. *Score range: 0-80 with higher score indicating greater symptom severity | CAPS-5 was only administered to veteran IP participants (i.e., half the total sample), not their intimate partners. | Mean | Standard Deviation | units on a scale |
|
| B-IPF | The Brief Inventory of Psychosocial Functioning (B-IPF) is a 7-item self-report questionnaire that assesses PTSD-related psychosocial functional impairment, an abridged version of the 80-item Inventory of Psychosocial Functioning questionnaire. *Score range: 0-100 with higher score indicating greater impairment | B-IPF was only administered to veteran IP participants (i.e., half the total sample), not their intimate partners. | Mean | Standard Deviation | units on a scale |
|
| CSI | Couples Satisfaction Index (CSI) is a 32-item self-report questionnaire designed to measure one's satisfaction in a relationship. *Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Some missing data on this scale at baseline due to reasons such as participant failure to complete self-report measure, participant declined to answer, or assessor did not administer based on clinical judgment at the time of assessment. | Mean | Standard Deviation | units on a scale |
|
| OG001 | CBCT-Office Based (CBCT-OB) | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. |
| OG002 | PTSD Family Education (PFE) | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office. |
|
|
| Primary | Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
|
| Primary | Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 3-Months Post Treatment |
|
|
|
| Primary | Clinician Administered PTSD Scale (CAPS) | The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma. *Score range: 0-80 with higher score indicating greater symptom severity | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 6- Months Post Treatment |
|
|
|
| Primary | Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Primary | Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately week 5 of all treatment conditions) |
|
|
|
| Primary | Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
|
| Primary | Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Primary | Couples Satisfaction Index (CSI) | The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 6- Months Post Treatment |
|
|
|
| Primary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Primary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately week 5 of all treatment conditions) |
|
|
|
| Primary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
|
| Primary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Primary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure designed to assess multiple dimensions of functional impairment related to psychiatric disturbances. Higher sum scores (range 0 to 100) indicate more functional impairment. | Entire enrolled sample, Veteran partners only; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 6- Months Post Treatment |
|
|
|
| Primary | Client Satisfaction Questionnaire (CSQ) | Client Satisfaction Questionnaire (CSQ) is an 8-item measure about satisfaction with treatment rated on a 4-point Likert scale. Higher mean scores (range 0 to 4) represent higher satisfaction with treatment services. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
| Primary | Working Alliance Inventory- Short Form (WAI-S) | This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Approximately week 3 of all treatment conditions |
|
|
|
| Primary | Working Alliance Inventory- Short Form (WAI-S) | This adaptation of the Working Alliance Inventory- short form (WAI-S) includes 14 items assessing therapeutic alliance as reported by the patient on a 7-point Likert scale. Higher sum scores (14 to 98) represent higher patient-reported working alliance. | Entire enrolled sample, both partners; imputed using fully Bayesian model-consistent multiple imputation | Posted | Mean | Standard Error | score on a scale | Approximately week 8 of all treatment conditions |
|
|
|
| Secondary | PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Secondary | PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately week 5 of all treatment conditions) |
|
|
|
| Secondary | PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
| Secondary | PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Secondary | PTSD Checklist-5 (PCL-5) | The PCL-5 is a 20 item self report questionnaire assessing symptoms of PTSD based on DSM-V criteria. Scores range from 0 to 80, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 6-Months Post Treatment |
|
|
|
| Secondary | Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Secondary | Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately Week 5 of all treatment conditions) |
|
|
|
| Secondary | Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners, using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
| Secondary | Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Secondary | Beck Depression Inventory-II (BDI-2) | The BDI is a 21-item self report questionnaire assessing symptoms of depression. Scores range from 0 to 63, with higher scores representing more severe symptoms. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 6-Months Post Treatment |
|
|
|
| Secondary | State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Secondary | State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately week 5 of all treatment conditions) |
|
|
|
| Secondary | State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
| Secondary | State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Secondary | State-Trait Anger Inventory (STAXI) | The STAXI-2 is a self-report questionnaire assessing state and trait anger. The State subscale (15 items) ranges from 15 to 60, and the Trait subscale (10 items) ranges from 10 to 40, with higher scores representing more anger. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 6-Months Post Treatment |
|
|
|
| Secondary | Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Secondary | Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Enrolled sample only, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | Mid Treatment (Approximately week 5 of all treatment conditions) |
|
|
|
| Secondary | Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 1 Month Post Treatment |
|
|
|
| Secondary | Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 3- Months Post Treatment |
|
|
|
| Secondary | Conflict Tactics Scale Short Form- (CTS-2S) | 20-item self-report inventory yielding 5 scales. Most widely used measure of its kind. Scores on the Psychological Aggression and Negotiation subscales range from 0 to 24, with higher scores representing more Psychological Aggression and more Negotiation. | Entire enrolled sample, both partners; using multiply imputed data | Posted | Mean | Standard Error | score on a scale | 6-Months Post Treatment |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 8 |
| 92 |
| EG001 | CBCT-Office Based (CBCT-OB) | Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. CBCT-Office Based (CBCT-OB): Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office. | 0 | 92 | 0 | 92 | 14 | 92 |
| EG002 | PTSD Family Education (PFE) | Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist's office. PTSD Family Education (PFE): Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office. | 0 | 90 | 0 | 92 | 14 | 90 |
|
| Hospitalization | General disorders | Non-systematic Assessment | Unrelated to study |
|
| Surgery | General disorders | Non-systematic Assessment | Unrelated to study |
|
| APC Report | Social circumstances | Non-systematic Assessment | Unrelated to study. Mandated report. |
|
| CPS Report | Social circumstances | Non-systematic Assessment | Unrelated to study. Mandated report. |
|
| Police visit | Investigations | Non-systematic Assessment | Unrelated to study. One incident where police visited participant's home due to noise complaint from domestic argument. |
|
| Protocol Deviation | Investigations | Non-systematic Assessment | Total of 2 protocol deviations reported (unrelated to study).
|
|
| Protocol Deviation-COVID-19 | General disorders | Non-systematic Assessment | Unrelated to study. Due to the COVID-19 pandemic shutdown in San Diego, a total of 10 participants (5 couples) received home-based telehealth treatment despite being randomized to an office-based condition. |
|
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). |
| Mixed-effects regression |
Models included random intercepts |
| .002 |
| Slope |
| -4.110 |
| Standard Error of the Mean |
| 1.308 |
| 2-Sided |
| Superiority |
| Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). | Mixed-effects regression | Models included random intercepts | .492 | Slope | -0.894 | Standard Error of the Mean | 1.296 | 2-Sided | Superiority |
| Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). | Mixed-effects regression | Models included random intercepts and included partners nested within couples | .686 | Slope | -0.931 | Standard Error of the Mean | 2.296 | 2-Sided | Superiority |
| Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). | Mixed-effects regression | Models included random intercepts and included partners nested within couples | .798 | Slope | -0.579 | Standard Error of the Mean | 2.256 | 2-Sided | Superiority |
|
Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). |
| Mixed-effects regression |
Models included random intercepts |
| .560 |
| Slope |
| -1.461 |
| Standard Error of the Mean |
| 2.495 |
| 2-Sided |
| Superiority |
| Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance). | Mixed-effects regression | Models included random intercepts | .922 | Slope | -0.248 | Standard Error of the Mean | 2.536 | 2-Sided | Superiority |
|
|
|
|
|
|
|
|
|
|
|
| Veterans - Trait subscale |
|
| Intimate Partners - Trait subscale |
|
|
| Veterans - Trait subscale |
|
| Intimate Partners - Trait subscale |
|
|
| Veterans - Trait subscale |
|
| Intimate Partners - Trait subscale |
|
|
| Veterans - State subscale |
|
| Intimate partners - State subscale |
|
|
| Veterans - Trait subscale |
|
| Intimate Partners - Trait subscale |
|
|
| Veterans - Negotiation subscale |
|
| Intimate Partners - Negotiation subscale |
|
|
| Veterans - Negotiation subscale |
|
| Intimate Partners - Negotiation subscale |
|
|
| Veterans - Negotiation subscale |
|
| Intimate Partners - Negotiation subscale |
|
|
| Veterans - Negotiation subscale |
|
| Intimate Partners - Negotiation subscale |
|
|
| Veterans - Negotiation subscale |
|
| Intimate Partners - Negotiation subscale |
|