Adults 18 to 65, any sex, with Mild Traumatic Brain Injury or Posttraumatic Stress Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)Primary· 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).
Baseline: Extent of Participation Subscale
Group
Value
95% CI
Treatment
36.4
± 7.8
Control
35.0
± 5.4
Post-Treatment: Extent of Participation Subscale
Group
Value
95% CI
Treatment
38.2
± 6.4
Control
35.1
± 6.1
6-Month Follow-Up: Extent of Participation Subscal
Group
Value
95% CI
Treatment
37.6
± 7.9
Control
38.0
± 6.5
Baseline: Perceived Limitations Subscale
Group
Value
95% CI
Treatment
41.0
± 4.9
Control
41.0
± 4.9
Post-Treatment: Perceived Limitations Subscale
Group
Value
95% CI
Treatment
41.7
± 5.1
Control
41.3
± 4.8
6-Month Follow-Up: Perceived Limitations Subscale
Group
Value
95% CI
Treatment
41.1
± 4.7
Control
42.3
± 4.5
Baseline: Satisfaction Subscale
Group
Value
95% CI
Treatment
39.8
± 6.0
Control
39.9
± 4.5
Post-Treatment: Satisfaction Subscale
Group
Value
95% CI
Treatment
41.0
± 5.7
Control
40.3
± 4.7
Change in Caregiver Burden InventorySecondary· 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.
Baseline
Group
Value
95% CI
Treatment
24.9
± 20.0
Control
25.8
± 16.5
Post-treatment
Group
Value
95% CI
Treatment
24.8
± 22.3
Control
25.6
± 15.0
6-month Post-Treatment
Group
Value
95% CI
Treatment
21.5
± 19.0
Control
27.1
± 20.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Duration of participants involvement in the study, up to ~ 16 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other recruiting trials for Mild Traumatic Brain Injury
Currently open trials in the same condition.
NCT07246993 — Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
· NA
· recruiting
NCT07356167 — Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
· NA
· recruiting
NCT07097792 — Concussion Recovery and Support Program
· NA
· recruiting
NCT06956417 — REhabilitation of MEMory Symptoms After BRain Concussion
· NA
· recruiting
NCT06217575 — Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
· NA
· recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 4 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02057081.