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

NCT01935609 | Completed

• 2 other identifiers: HM14736H133A120031
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To assess the impact of the TCI on the emotional well-being of persons with ABI and their partners.
3. 3.To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by partners of persons with ABI.
4. 4.To examine the extent to which treatment benefits for survivors and their caregiving partners are sustained in the longer-term.

Conditions

Traumatic Brain Injury; Acquired Brain Injury

Keywords

traumatic brain injury; acquired brain injury

Outcome Measures

Primary Outcomes (1)

• Revised Dyadic Adjustment Scale (RDAS)

  Couples' relationship quality will be measured using the Revised Dyadic Adjustment Scale (RDAS), an improved version of the Dyadic Adjustment Scale (DAS). The RDAS has 14 items which are rated using a Likert type scale with values ranging from 0-5 or 0-4. Total scores range from 0-69 with higher values indicating greater marital quality. Scores \< 48 are indicative of a distressed relationship. The RDAS has been found to be successful at distinguishing between distressed and non-distressed couples and is sensitive to treatment effects. Examples of items include, "Do you ever regret that you married or moved in together?," "Do you and your mate engage in outside interests together?," and "How often do you and your partner have a good conversation?" As done in other studies using the R-DAS, the present investigation will rely on the mean Total Score, incorporating Total Scores from each member of the couple.

  Change from Baseline to Post-Treatment (5-6 weeks after Baseline)

Secondary Outcomes (1)

• Brief Symptom Inventory-18 (BSI)

  Change from Baseline to Post-Treatment (5-6 weeks after Baseline)

Study Arms (2)

Couples counseling

EXPERIMENTAL

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.

Behavioral: Couples counseling

Waitlist Control

NO INTERVENTION

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.

Interventions

Couples counseling BEHAVIORAL

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.

Couples counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 31855018 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jeffrey S Kreutzer, PhD

  Professor, Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: September 5, 2013
• Study Start: March 1, 2013
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)