Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Traumatic Brain Injury; Acquired Brain Injury

Treatments: Behavioral: Couples counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01935609

HM14736

H133A120031 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Couples counseling

Experimental group

Description:

Intervention to promote couples' adjustment (TCI) - The TCI was developed based upon considerable clinical experience and research review. The TCI is a structured approach to helping couples after brain injury address issues related to relationship quality and emotional well-being. The TCI is implemented in five or six (optional parenting session) session. Each session is in-person and lasts for 120 minutes.

Treatment:

Behavioral: Couples counseling

Waitlist Control

No Intervention group

Description:

Couples are randomly assigned to the treatment group or waitlist control (WLC) group. Couples will complete the study measures on 2 occasions, 5 weeks apart. In fairness, WLC couples will then be offered the opportunity to participate in the intervention.