Depression Clinical Trial
— MFG-mTBIOfficial title:
Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
Verified date | May 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 249 |
Est. completion date | August 31, 2019 |
Est. primary completion date | March 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. Exclusion Criteria: Exclusion criteria for Veterans and partners are: - a lifetime diagnosis of a major psychiatric disorder (schizophrenia, schizoaffective or bipolar disorder with psychotic features) or active psychosis based on the Structured Clinical Interview for DSM-IV-TR (SCID-L) (First et al., 2007). - alcohol or drug abuse or dependence with past 6 months defined by a Short Michigan Alcoholism Screening Test (SMAST) (Selzer, 1975) 3, based on the recommended cut-off for TBI survivors (Gentilello et al.,1995) or a Drug Abuse Screening Test-10 (DAST-10) (Skinner, 1982) 3. - "severe" inter-partner violence as defined by the revised 20-item Conflict Tactics Scale Short Form (CTS2S) (Straus & Douglas, 2004). - a suicide attempt within the past 6 months (aborted and interrupted attempts) as assessed by the Columbia Suicide Severity Rating scale (C-SSRS). - medical condition or life event (e.g., ongoing or pending legal action in another state) that would compromise participation. - participation of either the caregiver or Veteran in another psychosocial intervention trial or couples' treatment six months prior to or during study or follow-up. Participation in individual psychotherapy and pharmacotherapy are permitted: use of and starting/stopping these services will be tracked. Participants will be screened for inclusion/exclusion as described above immediately after giving consent. |
Country | Name | City | State |
---|---|---|---|
United States | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland |
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
United States | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 | |
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. | Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 |
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