Depression, Mild Traumatic Brain Injury, Posttraumatic Stress Disorders
Conditions
Keywords
Stress Disorders, Post-traumatic, Mild Traumatic Brain Injury, Veterans Health, Veterans, Spouses, Couples, Psychotherapy, Group, Depression, Couples Therapy, Family Therapy, PTSD, posttraumatic stress disorder
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMultifamily 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.
BEHAVIORALGroup 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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. * The TBI must be either blast-related or attributable to another discrete event (e.g., fall, fight, injury) sustained during deployment in the OEF/OIF era. * Post-concussive symptoms (e.g., sleep or memory problems, headache) must not be attributable to a subsequent injury or other pre-existing or concurrent neurologic disorder: * Eligible Veterans must also have a consenting, qualifying spouse/cohabiting partner and a Montreal Cognitive Assessment (MoCA) (Nasreddine,2005) score 19. * The 30-item MoCA screens for impairment in specific areas of cognitive functioning deemed necessary for participation in a 90-minute, structured group including attention and concentration, executive functions, language and conceptual thinking. * We have specified a MoCA cut-off at the lower end of the range for mild cognitive dysfunction (19), in order to exclude Veterans with severe memory and/or other cognitive deficits, while admitting those with more mild deficits, as these represent our target population, i.e. Veterans with a history of mTBI. Inclusion criteria-partners: Legally married to or co-residing with Veteran for at least 6 months, with no plans for divorce or separation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden Inventory | Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant was consented but their partner did not consent.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| 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. | 80 |
| Total | 168 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 9.1 | 37.0 years STANDARD_DEVIATION 9.2 | 36.2 years STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 56 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) White | 44 Participants | 80 Participants | 36 Participants |
| Region of Enrollment United States | 88 Participants | 168 Participants | 80 Participants |
| Relationship Status Cohabitating | 24 Participants | 48 Participants | 24 Participants |
| Relationship Status Engaged | 8 Participants | 14 Participants | 6 Participants |
| Relationship Status Married | 56 Participants | 106 Participants | 50 Participants |
| Sex: Female, Male Female | 44 Participants | 84 Participants | 40 Participants |
| Sex: Female, Male Male | 44 Participants | 84 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 112 |
| other Total, other adverse events | 0 / 136 | 0 / 112 |
| serious Total, serious adverse events | 6 / 136 | 4 / 112 |
Outcome results
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).
Time frame: baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Extent of Participation Subscal | 37.6 score on a scale | Standard Deviation 7.9 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Extent of Participation Subscale | 36.4 score on a scale | Standard Deviation 7.8 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Extent of Participation Subscale | 38.2 score on a scale | Standard Deviation 6.4 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Perceived Limitations Subscale | 41.0 score on a scale | Standard Deviation 4.9 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Perceived Limitations Subscale | 41.7 score on a scale | Standard Deviation 5.1 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Perceived Limitations Subscale | 41.1 score on a scale | Standard Deviation 4.7 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Satisfaction Subscale | 39.8 score on a scale | Standard Deviation 6 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Satisfaction Subscale | 41.0 score on a scale | Standard Deviation 5.7 |
| Treatment | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Satisfaction Subscale | 39.3 score on a scale | Standard Deviation 3.4 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Satisfaction Subscale | 40.3 score on a scale | Standard Deviation 4.7 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Satisfaction Subscale | 39.9 score on a scale | Standard Deviation 4.5 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Perceived Limitations Subscale | 41.3 score on a scale | Standard Deviation 4.8 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Extent of Participation Subscale | 35.0 score on a scale | Standard Deviation 5.4 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Satisfaction Subscale | 38.9 score on a scale | Standard Deviation 7.9 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Post-Treatment: Extent of Participation Subscale | 35.1 score on a scale | Standard Deviation 6.1 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Extent of Participation Subscal | 38.0 score on a scale | Standard Deviation 6.5 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | 6-Month Follow-Up: Perceived Limitations Subscale | 42.3 score on a scale | Standard Deviation 4.5 |
| Control | Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) | Baseline: Perceived Limitations Subscale | 41.0 score on a scale | Standard Deviation 4.9 |
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.
Time frame: Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44
Population: Only partner/spouse participants were administered and evaluated on this outcome (not veterans).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Change in Caregiver Burden Inventory | Baseline | 24.9 score on a scale | Standard Deviation 20 |
| Treatment | Change in Caregiver Burden Inventory | Post-treatment | 24.8 score on a scale | Standard Deviation 22.3 |
| Treatment | Change in Caregiver Burden Inventory | 6-month Post-Treatment | 21.5 score on a scale | Standard Deviation 19 |
| Control | Change in Caregiver Burden Inventory | Baseline | 25.8 score on a scale | Standard Deviation 16.5 |
| Control | Change in Caregiver Burden Inventory | Post-treatment | 25.6 score on a scale | Standard Deviation 15 |
| Control | Change in Caregiver Burden Inventory | 6-month Post-Treatment | 27.1 score on a scale | Standard Deviation 20.1 |