Clinical trial NCT01935609: Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples
Official title: Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples (a Research Project Within the Traumatic Brain Injury Model System Grant)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Acquired Brain Injury
Keywords: traumatic brain injury
acquired brain injury
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2013-09-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. To evaluate the efficacy of a structured outpatient couples intervention program (Therapeutic Couples Intervention, TCI) on couples' marital quality after acquired brain injury (ABI).
2. To assess the impact of the TCI on the emotional well-being of persons with ABI and their partners.
3. To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by partners of persons with ABI.
4. To examine the extent to which treatment benefits for survivors and their caregiving partners are sustained in the longer-term.

Detailed description: Much of the research on acquired brain injury (ABI) has focused on survivors, especially functional and neurobehavioral outcomes. In recent years, researchers have begun to develop and evaluate interventions designed to improve whole family functioning. Studies have demonstrated that intervention can increase survivors' and family members' problem solving skills, met needs, emotional adjustment, and perceptions about the quality of rehabilitation services.

Research suggests at least one of every three survivors is in a martial or coupled relationship at the time of injury. The literature examining postinjury marital breakdown has yielded widely varying results with estimates of breakdown rates ranging from 15%-78%. Whereas early studies suggested a majority of marriages ended in divorce, more recent studies have indicated that marital breakdown rates for people with brain injury are substantially lower than the general population. At the same time, research has generated concern that while many people remain together the quality of the relationship is sorely diminished.

There is little doubt that healthy marriages and intimate relationships are important elements of our society. Further, research in other medical disciplines has proven the positive impact marital quality has on marital stability, emotional well-being, caregiver burden, and family needs. Existing study has similarly established the sustained benefits of promoting marital quality through intervention. Given the documented adverse impacts of brain injury, there is a clear need for effective interventions to improve and maintain the quality of coupled relationships.

To improve couples' relationship quality after ABI, and to target emotional well-being and caregiver burden, VCU researchers developed a curriculum-based program for couples (Therapeutic Couples Intervention, TCI). The study addresses issues and challenges commonly confronting couples after brain injury. Relationship quality is a primary focus of the study with the perceptions of both partners analyzed, allowing an understanding of individual viewpoints and those of the couple as a whole. Objectives include:

1. to evaluate the efficacy of a structured outpatient couples intervention program (TCI) on couples' marital quality
2. to assess the impact of the TCI on the emotional well-being of persons with ABI and their partners
3. to ascertain the impact of the TCI on caregiver burden and unmet needs as reported by partners of persons with ABI
4. to examine the extent to which treatment benefits for survivors and their caregiving partners are sustained in the longer-term

Eligibility criteria: Inclusion Criteria:

* partners and persons with ABI who are at least three months post-injury or post-diagnosis
* ABI is defined as damage to brain tissue caused by aneurysm, brain abscess, stroke, anoxia, or non-progressive brain tumor, or an external mechanical force as evidenced by: loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to ABI on physical examination or mental status examination.
* a "partner" is defined as a person described by the individual with the injury as a spouse, partner, or significant other
* able to understand and provide consent

Exclusion Criteria:

* active substance abusers (e.g., intoxicated at arrival to intake)
* at imminent risk of psychiatric hospitalization
* in imminent danger of hurting themselves or others
* individuals without a partner

Primary outcomes:
measure: Revised Dyadic Adjustment Scale (RDAS)
timeFrame: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Secondary outcomes:
measure: Brief Symptom Inventory-18 (BSI)
timeFrame: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Professor, Virginia Commonwealth University
name: Jeffrey S Kreutzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graham KM, Kreutzer JS, Marwitz JH, Sima AP, Hsu NH. Can a couples' intervention reduce unmet needs and caregiver burden after brain injury? Rehabil Psychol. 2020 Nov;65(4):409-417. doi: 10.1037/rep0000300. Epub 2019 Dec 19.