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Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI (MFG-mTBI)

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ClinicalTrials.gov Identifier: NCT02057081
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE February 6, 2014
Results First Submitted Date  ICMJE March 13, 2020
Results First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE October 9, 2014
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Change in Sydney Psychosocial Reintegration Scale [ Time Frame: pre-treatment in study month 5, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 ]
A 12-item scale designed to measure psychosocial reintegration after TBI, targeting three domains in which the TBI population experiences particular difficulty: occupational activity (both work and leisure), interpersonal relationships, and independent living skills.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Change in Caregiver Burden Inventory [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Change in Caregiver Burden Inventory [ Time Frame: pre-treatment in study month 5, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 ]
A 24-item scale that will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
Official Title  ICMJE Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Traumatic Brain Injury
  • Posttraumatic Stress Disorders
  • Depression
Intervention  ICMJE
  • Behavioral: 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.
    Other Name: MFG-mTBI-C
  • Behavioral: 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.
    Other Name: GHE
Study Arms  ICMJE
  • Experimental: Treatment
    Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.
    Intervention: Behavioral: Multifamily Group for mTBI for Couples
  • Active Comparator: Control
    Didactic 14-session educational group intervention for families.
    Intervention: Behavioral: Group Health Education (GHE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2020)
249
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
360
Actual Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057081
Other Study ID Numbers  ICMJE D1106-R
1I01RX001106 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy L Drapalski, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
PRS Account VA Office of Research and Development
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP