Depression Clinical Trial
Official title:
Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
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 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |