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N/A N=248 Randomized Double-blind Treatment

Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI

Mild Traumatic Brain Injury · Posttraumatic Stress Disorders · Depression

Enrolled (actual)
248
Serious AEs
4.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) — 36.4; 35.0; 38.2; 35.1 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Multifamily Group for mTBI for Couples (Behavioral); Group Health Education (GHE) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
36.4; 35.0; 38.2; 35.1; 37.6; 38.0
SECONDARY
Change in Caregiver Burden Inventory
24.9; 25.8; 24.8; 25.6; 21.5; 27.1

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.

Eligibility Criteria

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 ( 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02057081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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