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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX001783 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| Southeast Louisiana Veterans Health Care System | FED |
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Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been "rolled out" nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpersonal Psychotherapy for PTSD | Experimental | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions |
|
| Prolonged Exposure | Active Comparator | Exposure based intervention including exposure to memories and avoided places and activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpersonal Therapy for PTSD | Behavioral | Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS-5) | Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Inventory of Interpersonal Functioning (IIP-32) | Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome. | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracie M. Shea, PhD | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Louisiana Veterans Health Care System, New Orleans, LA | New Orleans | Louisiana | 70112 | United States | ||
not developed yet
Following publication of primary and secondary study findings
uncertain at this point
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| ID | Title | Description |
|---|---|---|
| FG000 | IPT-PTSD | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. |
| FG001 | Prolonged Exposure | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
While a total of 115 participants were randomized to IPT-PTSD (n=61) and Prolonged Exposure (n=54), 6 participants dropped before starting treatment therefore treatment analysis is based on a sample of 109 (58 IPT-PTSD and 51 Prolonged Exposure) participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | IPT-PTSD | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Clinician Administered PTSD Scale (CAPS-5) | Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
Baseline to 6 months post-treatment, an average of 9 months
Definitions do not differ.
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 | IPT-PTSD | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization - Alcohol | Psychiatric disorders | Non-systematic Assessment |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracie Shea | Providence VA Medical Center | 401-273-7100 | 6248 | MaryTracie.Shea@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2018 | Mar 17, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2019 | May 20, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Prolonged Exposure | Behavioral | Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). |
|
| Change in Patient Health Questionnaire (PHQ) | Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome. | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Concise Health Risk Tracking Scale - Total (CHRT) | Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in Work and Social Adjustment Scale (WSAS) | Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome. | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
| Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
| Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
| GAD - 7 Generalized Anxiety Disorder | Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome. | Baseline to 6 months posttreatment |
| Providence VA Medical Center, Providence, RI |
| Providence |
| Rhode Island |
| 02908 |
| United States |
| Never Started |
|
| Lost Interest |
|
| Miscellaneous Life Issues |
|
| Infrequent Attendance |
|
| Timed Out |
|
| AUD relapse |
|
| Legal Issue |
|
| BG001 | Prolonged Exposure | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Clinician Assessment of PTSD Symptoms Version 5 (CAPS-5) | The Clinician Assessment of PTSD Symptoms Version 5 (CAPS-5) is used to assess change in PTSD symptoms in the past month. Item scores can range from 0 to 4 with total scores ranging from 0 to 80. Higher scores reflect more severe symptomatology. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist Military Version 5 (PCL-M-5) | PTSD Checklist Military Version 5 (PCL-M-5) is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD and PTSD symptom severity on a 5-point scale among military personnel. The self-report rating scale is 0-4 for each symptom, from 0 indicating that the subject endorses the frequency of this symptom as "Not at all" to 4 indicating the frequency as "Extremely." Scores can range from 0 - 80. Higher scores indicate more severe symptomatology. | Missing data from subjects at Baseline | Mean | Standard Deviation | units on a scale |
|
| Inventory of Interpersonal Functioning (IIP-32) | The Inventory of Interpersonal Functioning (IIP-32), is a 32 item questionnaire used to assess change in interpersonal functioning. Item scores range from 0 to 4 (0= Not at all to 4= extremely). Higher scores reflect worse interpersonal functioning.Total scores are based upon the mean of item ratings and range from 0 to 4. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire (PHQ-9) | Patient Health Questionnaire, the PHQ,-9, is a nine item version of the Primary Care Evaluation of Mental Health - MD Version (PRIME-MD) which contains the mood (PHQ-9) and anxiety modules in the original PRIME-MD. Scores can range from 0 "Not at all" to 3 "Nearly every day". Total scores range from 0 to 27 with higher scores indicating more severe depression. | Mean | Standard Deviation | units on a scale |
|
| Generalized Anxiety Disorder (GAD-7) | Generalized Anxiety Disorder - 7 Item (GAD-7) measures a participant's anxiety symptoms. Scores range from 0 to 3 with total score ranging from 0 - 21. Higher scores indicate more severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Scale of Perceived Social Support (MSPSS - Significant Other) | Multidimensional Scale of Perceived Social Support (MSPSS - Significant Other) is a 4 item subscale that measures perceived social support from the participant's significant other. Item scores range from 1 - 7 with total scores ranging from 4 - 28 with lower scores indicating lower perceived support. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Multidimensional Scale of Perceived Social Support (MSPSS - Family) is a 4 item subscale that measures perceived social support from the participant's family. Item scores range from 1 - 7 with total scores ranging from 4 - 28 with lower scores indicating lower perceived support. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Scale of Perceived Support (MSPSS) - Friends | MSPPS - Friends is a 4 item subscale self report measure of perceived social support from friends scored on a scale from 1 - 7.that measures perceived social support from the participant's friends. Item scores range from 1 - 7 with total scores ranging from 4 - 28 with lower scores indicating lower perceived support. | Mean | Standard Deviation | units on a scale |
|
| Concise Health Risk Tracking (CHRT) Scale - Total | Concise Health Risk Tracking Scale (CHRT) Total is a 12-item self-report measure of suicidal ideation, hopelessness, and interpersonal attachment/social support. All items are rated on a 5-point scale (1 = strongly disagree, 5 = strongly agree). Scores range from a minimum value of 12 to a maximum value of 60 for our study. Higher scores indicate more risk for suicidal behavior. | Mean | Standard Deviation | units on a scale |
|
| Concise Health Risk Tracking (CHRT) - Propensity | Concise Health Risk Tracking Scale (CHRT) is a self-report measure of suicidal ideation, hopelessness, and interpersonal attachment/social support. All items are rated on a 5-point scale. The Propensity subscale score is the total of items 1 - 9 and can range for our study from a minimum value of 9 to a maximum value of 45. Higher scores indicate more risk for suicidal behavior. | Mean | Standard Deviation | units on a scale |
|
| Concise Health Risk Tracking (CHRT) - Suicidal Thoughts | Concise Health Risk Tracking Scale (CHRT) Suicidal Thoughts is a 12-item self-report measure of suicidal ideation, hopelessness, and interpersonal attachment/social support. All items are rated on a 5-point scale. The Suicidal Thoughts subscale score is the total of items 10 - 12 and can range for our study from a minimum value of 3 to a maximum value of 15. Higher scores indicate higher levels of suicidal behavior. | Mean | Standard Deviation | units on a scale |
|
| Work & Social Adjustment Scale (WSAS) Total | Work & Social Adjustment Scale (WSAS) Total is a self-report scale of functional impairment attributable to an identified problem in five different areas: ability to work, home management, social leisure, personal leisure, and maintaining close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores reflect more impairment in functioning. | Mean | Standard Deviation | units on a scale |
|
| WHO-QOL-BREF Item 1 Quality of Life | WHO Short Form Quality of Life Measure (WHOQOL-BREF) produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. Item scores range from 1 - 5. Higher scores reflect better quality of life. | Mean | Standard Deviation | units on a scale |
|
| WHO-QOL-BREF Item 2 Satisfaction with Health | WHO Short Form Quality of Life Measure (WHOQOL-BREF) produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. . Item scores range from 1 - 5. Higher scores reflect more satisfaction with health. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Prolonged Exposure | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). |
| OG002 | Difference Mean | Difference between mean of IPT-PTSD and Prolonged Exposure |
|
|
|
| Primary | Change in Inventory of Interpersonal Functioning (IIP-32) | Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. | Some participants skipped assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Patient Health Questionnaire (PHQ) | Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk. | Some Veterans skipped assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
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| Secondary | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome. | Some Veterans skipped assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts. | Some Veterans missed assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
|
| Secondary | Change in Work and Social Adjustment Scale (WSAS) | Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome. | Some Veterans missed completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
|
|
|
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| Secondary | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. | Some Veterans missed completing assessments | Posted | Mean | Standard Deviation | score on a scale | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
|
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|
|
| Secondary | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
|
|
|
|
| Secondary | GAD - 7 Generalized Anxiety Disorder | Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome. | Some Veterans skipped completing assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months posttreatment |
|
|
|
|
| 0 |
| 61 |
| 8 |
| 61 |
| 0 |
| 61 |
| EG001 | Prolonged Exposure | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | 0 | 54 | 3 | 54 | 0 | 54 |
| Inpatient Hospitalization-Depression/Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Domestic Violence issue - Sustained minor injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Inpatient Hospitalization - Drugs | Psychiatric disorders | Non-systematic Assessment |
|
| Inpatient Hospitalization-Schizoaffective Disorder | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| 4 Week |
|
|
| 8 Week |
|
|
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Post Treatment |
|
|
| 6 Month Post Treatment |
|
|
One sided 97.5% confidence interval, superiority margin was 0.5 |
| 0.34 |
| Other |
| 8-Week | t-test, 1 sided | One sided 97.5% confidence interval, superiority margin was 0.5 | 0.43 | Other |
| 6 Month Post Treatment | t-test, 1 sided | One sided 97.5% confidence interval, superiority margin was 0.5 | 0.09 | Other |
| End of Treatment | t-test, 1 sided | One sided 97.5% confidence interval, superiority margin was 0.5 | 0.41 | Other |
| Change | t-test, 1 sided | One sided 97.5% confidence interval, superiority margin was 0.5 | 0.64 | Superiority | Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05). |
| 3 Month Post Treatment | t-test, 1 sided | One sided 97.5% confidence interval, superiority margin was 0.5 | 0.22 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3-Month Follow Up |
|
|
| 6-Month Follow Up |
|
|
| 0.65 |
| Other |
| Change | t-test, 1 sided | 0.64 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.64 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.76 | Other |
| Week 4 |
|
|
| Week 8 |
|
|
| End of Treatment |
|
|
| Change |
|
|
| 3 Month |
|
|
| 6 Month |
|
|
| Other |
| 8-Week | t-test, 1 sided | 0.74 | Other |
| End of Treatment | t-test, 1 sided | 0.34 | Other |
| Change | t-test, 1 sided | 0.65 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.14 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.18 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Post Tx |
|
|
| 6 Month Post Tx |
|
|
| 0.07 |
| Other |
| Change | t-test, 1 sided | 0.86 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.003 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.03 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Post Tx |
|
|
| 6 Month Post Tx |
|
|
| 0.04 |
| Other |
| Change | t-test, 1 sided | 0.86 | Other |
| 3 Month Post Treatment | t-test, 1 sided | <0.001 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.16 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Post Tx |
|
|
| 6 Month Post Tx |
|
|
| 0.71 |
| Other |
| Change | t-test, 1 sided | 0.60 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.13 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.80 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3-Month Follow Up |
|
|
| 6-Month Follow Up |
|
|
| 0.11 |
| Other |
| Change | t-test, 1 sided | 0.74 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.03 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.22 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3-Month Follow Up |
|
|
| 6-Month Follow Up |
|
|
| 0.15 |
| Other |
| Change | t-test, 1 sided | 0.72 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.04 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.19 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3-Month Follow Up |
|
|
| 6-Month Follow Up |
|
|
| 0.11 |
| Other |
| Change | t-test, 1 sided | 0.88 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.06 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.56 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Post Tx |
|
|
| 6 Month Post Tx |
|
|
| 0.06 |
| Other |
| Change | t-test, 1 sided | 0.46 | Other |
| 3 Month Post Treatment | t-test, 1 sided | 0.001 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.002 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 0.81 |
| Other |
| Change | t-test, 1 sided | 0.24 | Other |
| End of Treatment |
|
|
| Change |
|
|
| 0.21 |
| Other |
| Change | t-test, 1 sided | 0.50 | Other |
| Week 4 |
|
|
| Week 8 |
|
|
| End of Treatment |
|
|
| Change |
|
|
| 3 Month Follow Up |
|
|
| 6 Month Follow Up |
|
|
| Other |
| Week 8 | t-test, 1 sided | 0.59 | Other |
| End of Treatment | t-test, 1 sided | 0.61 | Other |
| Change | t-test, 1 sided | 0.84 | Other |
| 3 Month Follow Up | t-test, 1 sided | 0.30 | Other |
| 6 Month Post Treatment | t-test, 1 sided | 0.16 | Other |