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| ID | Type | Description | Link |
|---|---|---|---|
| IK2CX001589 | U.S. NIH Grant/Contract | View source |
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This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.
The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study.
Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment.
Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief family intervention | Experimental | Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. |
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| No intervention | No Intervention | Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Family Intervention | Behavioral | Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale, 5th Edition | A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome. | 16 weeks |
| Treatment Attendance/Dropout | A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Significant Others' Responses to Trauma Scale (SORTS) | A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome. | 16 weeks |
| Revised Dyadic Adjustment Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna Thompson-Hollands, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
Data may be released to other researchers as VA policy allows.
Entire study (baseline to 16 weeks)
As per VA policy and local IRB approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Family Intervention - Veterans | The family members of these veterans will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals. |
| FG001 | No Intervention - Veterans | The family members of these veterans will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. |
| FG002 | Brief Family Intervention - Family Members | Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals. |
| FG003 | No Intervention - Family Members | These family members will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Individuals (Veterans or family members) assigned to each group. The arms are paired -- the two Brief Family Intervention groups are paired dyad members, and the Usual-care CPT/PE Veterans and the No Intervention Family Members are also paired dyad members.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Family Intervention - Veterans | Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD. Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE. |
| BG001 | Usual-care CPT/PE - Veterans |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Clinician-Administered PTSD Scale, 5th Edition | A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome. | Only Veterans | Posted | Mean | Standard Deviation | score on a scale | 16 weeks |
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16 weeks
No difference in definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Family Intervention - Veterans | Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD. Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication overdose | Psychiatric disorders | Non-systematic Assessment | Participant took more of their (non-study) psychiatric medication than was prescribed. No intervention was required. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johanna Thompson-Hollands | VA Boston Healthcare System | 857-364-2311 | johanna.thompson-hollands@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 | Jul 2, 2021 | Sep 7, 2021 | Prot_SAP_000.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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A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.
| 16 weeks |
Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD. Their chosen family member will NOT receive the BFI. |
| BG002 | Brief Family Intervention - Family Members | Family members will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals. |
| BG003 | No Intervention - Family Members | Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| CAPS-5 | Min value = 0, max value = 80. Higher scores mean worse outcome. | Only Veterans were administered the CAPS-5 | Mean | Standard Deviation | units on a scale |
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| SORTS | Min value = 0, max value = 112. Higher scores mean worse outcome. | Only family members completed the SORTS | Mean | Standard Deviation | units on a scale |
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| Primary | Treatment Attendance/Dropout | A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment. | Only veterans | Posted | Count of Participants | Participants | 16 weeks |
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| Secondary | Significant Others' Responses to Trauma Scale (SORTS) | A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome. | Only family members | Posted | Mean | Standard Deviation | score on a scale | 16 weeks |
|
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| Secondary | Revised Dyadic Adjustment Scale | A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome. | Only family members | Posted | Mean | Standard Deviation | score on a scale | 16 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Usual-care CPT/PE - Veterans | Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD. Their chosen family member will NOT receive the BFI. | 0 | 10 | 2 | 10 | 0 | 10 |
| EG002 | Brief Family Intervention - Family Members | Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | No Intervention - Family Members | Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant was involuntarily hospitalized following an aggressive episode |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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