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



Status:Active, not recruiting
Conditions:Depression, Depression, Hospital, Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 65
Updated:3/3/2019
Start Date:October 9, 2014
End Date:August 31, 2019

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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.

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: 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.

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.
We found this trial at
3
sites
New York, New York 10010
Phone: 212-686-7500
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Baltimore, Maryland 21201
Principal Investigator: Amy Lynne Drapalski, PhD
Phone: (410) 637-1855
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Bronx, New York 10468
Phone: 718-584-9000
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Bronx, NY
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