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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02057081
First received: January 22, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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) 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 mTBI 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 OEF/OIF Veterans with mTBI offered within the VA spectrum of services, this intervention fills a crucial gap in healthcare for our newest Veterans.


Condition Intervention
Mild Traumatic Brain Injury
Posttraumatic Stress Disorders
Depression
Behavioral: Multifamily Group for mTBI for Couples
Behavioral: Group Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in The Computer Adaptive Test version of the Community Reintegration of Injured Service Members (CRIS-CAT) [ 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 ] [ Designated as safety issue: No ]
    The CRIS assesses community reintegration through the assessment of participation in life roles. Items on the CRIS cover 9 aspects of participation: 1) Learning and Applying Knowledge, 2) General Tasks and Demands, 3) Communication, 4) Mobility, 5) Self-care, 6) Domestic Life, 7) Interpersonal Relationships, 8) Major Life Areas, and 9) Community, Social, and Civic Life.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A 24-item scale that will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.


Estimated Enrollment: 360
Study Start Date: September 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Intensive 12-session psychoeducational rehabilitation and skills-building intervention for couples.
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
Active Comparator: Control
Didactic 14-session educational group intervention for families.
Behavioral: Group Health Education
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

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 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=180) with a positive 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 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: 1) 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; 2) that improvement in CI will be mediated by improvement in marital satisfaction and Veteran anger management and social support; 3) that Veterans with more intact cognitive functioning at baseline will show greater improvement in CI, anger management, social support and marital satisfaction. If efficacious, MFG-mTBI-C has the potential to assist Veterans with mTBI and their partners throughout the VA Health Care System.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria-Veterans:

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.
  • Although referrals will be based on a positive DVBIC screen, the diagnosis must be confirmed by Parts A-C of the VA TBI Identification Clinical Interview (Vanderploeg et al., 2012).
  • 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:

    • Veterans with pre-existing or concurrent neurologic conditions (head trauma, seizures, strokes, neurosurgery, other neurologic impairments based on medical record or self-report) will be excluded.
  • 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 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 2-year period of 'worst point' suicidal ideation (including during the past week) at either of the two highest levels of ideation severity (intent or intent with plan) assessed by the Columbia Suicide Severity Rating scale (C-SSRS): "worst point" scoring at these levels of ideation was associated with a fourfold increase in risk of a future attempt compared to the risk associated with current, less severe ideation (Posner et al., 2007).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057081

Contacts
Contact: Deborah A Perlick, PhD (914) 260-7453 deborah.perlick@va.gov
Contact: Erin Hazlett, PhD (718) 584-9000 ext 3701 erin.hazlett@mssm.edu

Locations
United States, Maryland
Rehabilitation R&D Service, Baltimore, MD Not yet recruiting
Baltimore, Maryland, United States, 21202
Contact: Amy Drapalski, PhD    410-637-1880    amy.drapalski@va.gov   
United States, New York
James J. Peters VA Medical Center, Bronx, NY Not yet recruiting
Bronx, New York, United States, 10468
Contact: Deborah A Perlick, PhD    914-260-7453    deborah.perlick@va.gov   
Contact: Erin Hazlett, PhD    (718) 584-9000 ext 3701    erin.hazlett@mssm.edu   
Principal Investigator: Deborah A Perlick, PhD         
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Not yet recruiting
New York, New York, United States, 10010
Contact: Adam Wolkin, MD    212-686-7500 ext 7521    adam.wolkin@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah A Perlick, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02057081     History of Changes
Other Study ID Numbers: D1106-R, 1I01RX001106
Study First Received: January 22, 2014
Last Updated: July 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress Disorders, Post-traumatic
Mild Traumatic Brain Injury
Veterans Health
Veterans
Spouses
Couples
Psychotherapy, Group
Depression
Couples Therapy
Family Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Traumatic
Brain Injuries
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014