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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RX001106 | U.S. NIH Grant/Contract | View source |
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This project addresses the rehabilitation and mental health needs of married combat Veterans post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by providing psychoeducation, communication and problem solving skills in a multifamily group (MFG) setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic strategies to help compensate for deficits and promote Veteran community integration, interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of the skills-based MFG will be compared to that of a health education group which offers a supportive environment and basic education without skills training through a randomized clinical trial. As there is currently no family-based intervention for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum of services, this intervention fills a crucial gap in healthcare for our newest Veterans.
Mild traumatic brain injury (mTBI), an injury or concussion associated with brief loss of consciousness or altered mental state, has affected as many as 35% of soldiers wounded during recent military actions in Iraq and Afghanistan. Up to 30% of those injured report persistent somatic, emotional and cognitive post-concussive symptoms (PCS) which may adversely impact family life and community re-integration. Marital conflict and intimate partner violence, reported by 54% of OEF/OIF couples, and co-occurring mental health problems may exacerbate cognitive dysfunction and delay rehabilitation. A key contributor to marital conflict is a lack of knowledge about the Veteran's condition and the skills needed to help him compensate for common deficits in memory and planning which create challenges in household management. Despite a growing evidence base for couples treatment for PTSD, there is no established family-based treatment for OEF/OIF Veterans with mTBI, creating a critical research and services gap. The proposed research aims to fill this gap by evaluating a novel form of multi-family group treatment designed to improve community integration (CI) among married/cohabiting OEF/OIF Veterans with mTBI and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by training spouse/partners to aid with rehabilitation and employing disability-adapted communication and problem-solving skills to reduce marital conflict and improve marital satisfaction.
Veterans (N=150) with a positive Defense and Veterans Brain Injury Center (DVBIC) screen for mTBI sustained during the OEF/OIF era, confirmed by the VA Identification Clinical Interview and a Montreal Cognitive Assessment (MoCA) score 19 or if they either meet diagnostic criteria for PTSD or have trauma- or CS of at least moderate severity, as defined by either a) PTSD Checklist (PCL) score >34 or b) Customer Effort Score (CES) score of >23, will be randomized to receive either: 1) Multifamily Group for TBI for Couples (MFG-mTBI-C), a psychoeducational, rehabilitation and skills-building intervention consisting of a 2-session multifamily educational workshop providing information about TBI and 12 bi-monthly multifamily group meetings providing skills training in problem-solving and communication related to cognitive/emotional deficits; or 2) 14 bi-monthly multifamily group sessions delivering health education without skills training. Both treatments will be preceded by 2-3 individual couples sessions. Participants will be assessed pre- and post-treatment and 6 months post-treatment. Data will be analyzed using an intent-to-treat analysis with paired comparisons between treatment groups on primary (Veteran CI, caregiver burden) and secondary (anger management, use of social supports) outcome variables using mixed effects regression models. It is hypothesized that Veterans treated with MFG-mTBI-C will show improved CI, anger management and use of social support, and spouse/partners will show reduced burden compared with those treated in the health education group. If efficacious, MFG-mTBI-C has the potential to assist Veterans with mTBI and their partners throughout the VA Health Care System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. |
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| Control | Active Comparator | Didactic 14-session educational group intervention for families. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifamily Group for mTBI for Couples | Behavioral | MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | The Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) was used to measure community reintegration. The measure includes 3 subscales: Extent of Participation, Perceived Limitations, and Satisfaction. A total score for each subscale is calculated by summing item responses (range= 10 to 140), with higher scores indicating greater frequency of community participation (extent of participation), greater perceived limitations to community participation (perceived limitations), and greater satisfaction with community participation (satisfaction). | baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Burden Inventory | The Caregiver Burden Inventory is a 24-item scale that measures caregiver burden in four areas: physical, social, emotional and time dependence burden. A total score is calculated by summing the item responses (range= 1 to 100), with higher scores indicating greater caregiver burden. | Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 |
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Inclusion Criteria:
Eligible Veterans must have a diagnosis of mTBI in accordance with the VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury: injury or concussion associated with at least one of the following: brief (< 30 minutes) loss of consciousness or altered state of consciousness or post-traumatic amnesia for < 24 hours following the injury, or they either meet diagnostic criteria for PTSD based on the MINI or have trauma- or CS of at least moderate severity, as defined by either: a) PCL score >34; or b) CES score of >23.
Inclusion criteria-partners: Legally married to or co-residing with Veteran for at least 6 months, with no plans for divorce or separation.
Exclusion Criteria:
Exclusion criteria for Veterans and partners are:
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| Name | Affiliation | Role |
|---|---|---|
| Amy L Drapalski, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States | ||
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One participant was consented but their partner did not consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 22, 2017 |
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| Group Health Education (GHE) | Behavioral | GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas. |
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| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY |
| New York |
| New York |
| 10010 |
| United States |
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468 | United States |
| FG001 |
| Control |
Didactic 14-session educational group intervention for families. Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas. |
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| Completed Baseline | Veterans and partners who were consented, randomized, completed baseline and deemed eligible |
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| Post-Treatment Assessment | Includes both veteran and partner participants |
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| COMPLETED | Includes both veteran and partner participants |
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| NOT COMPLETED |
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Reflects demographic characteristics of those participants who consent, were randomized and completed the baseline assessment (does not include those that were enrolled and did not complete or who were ineligible)
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges. |
| BG001 | Control | Didactic 14-session educational group intervention for families. Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas. |
| BG002 | Total | Total of all reporting groups |
| 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 | Age is missing for one participant assigned to the experimental treatment condition | Mean | Standard Deviation | 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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| Region of Enrollment | Count of Participants | Participants |
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| Relationship Status | Count of Participants | Participants |
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| 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 the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | The Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) was used to measure community reintegration. The measure includes 3 subscales: Extent of Participation, Perceived Limitations, and Satisfaction. A total score for each subscale is calculated by summing item responses (range= 10 to 140), with higher scores indicating greater frequency of community participation (extent of participation), greater perceived limitations to community participation (perceived limitations), and greater satisfaction with community participation (satisfaction). | Only veteran participants were administered and evaluated on this outcome (not their partners). Two participants from the treatment group and 3 participants from the control group were missing data for this outcome at baseline. | Posted | Mean | Standard Deviation | score on a scale | baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 |
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| Secondary | Change in Caregiver Burden Inventory | The Caregiver Burden Inventory is a 24-item scale that measures caregiver burden in four areas: physical, social, emotional and time dependence burden. A total score is calculated by summing the item responses (range= 1 to 100), with higher scores indicating greater caregiver burden. | Only partner/spouse participants were administered and evaluated on this outcome (not veterans). | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 |
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Duration of participants involvement in the study, up to ~ 16 months
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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 | Treatment | Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. Multifamily Group for mTBI for Couples: MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges. | 0 | 136 | 6 | 136 | 0 | 136 |
| EG001 | Control | Didactic 14-session educational group intervention for families. Group Health Education (GHE): GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas. | 0 | 112 | 4 | 112 | 0 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| self-reported interpersonal violence | Social circumstances | Non-systematic Assessment | Self-reported physical altercation with partner |
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| psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| medical hospitalization | Surgical and medical procedures | Non-systematic Assessment |
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| Medical hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Medical hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Medical hospitalization | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Drapalski | VISN 5 Mental Illness Research, Education, and Clinical Center | 410-637-1855 | amy.drapalski@va.gov |
| Mar 12, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Cohabitating |
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| Engaged |
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| Post-Treatment: Extent of Participation Subscale |
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| 6-Month Follow-Up: Extent of Participation Subscal |
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| Baseline: Perceived Limitations Subscale |
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| Post-Treatment: Perceived Limitations Subscale |
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| 6-Month Follow-Up: Perceived Limitations Subscale |
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| Baseline: Satisfaction Subscale |
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| Post-Treatment: Satisfaction Subscale |
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| 6-Month Follow-Up: Satisfaction Subscale |
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