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

Primary Purpose

Traumatic Brain Injury, Acquired Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Couples counseling
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, acquired brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Couples counseling

Waitlist Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Brief Symptom Inventory-18 (BSI)
The Brief Symptom Inventory-18 (BSI-18) is an 18 item self-report instrument designed to quantify psychological distress in the general population. Increasingly, the measure has been used to quantify individuals and family members' distress after ABI. The instrument is a psychometrically sound, abbreviated version of the SCL-90-R. Frequency ratings for items in three primary symptom dimensions are added to yield scores for Somatization, Depression, and Anxiety. The Global Severity Index (GSI) reflects the sum of scores for the three symptom dimensions. T-scores for each dimension and the GSI are calculated based on community norms. GSI scores, reflecting overall distress levels, will be used in the present investigation.

Full Information

First Posted
August 21, 2013
Last Updated
October 26, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01935609
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 28, 2016 (Actual)
Study Completion Date
September 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Acquired Brain Injury
Keywords
traumatic brain injury, acquired brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Couples counseling
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Couples counseling
Intervention 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.
Primary Outcome Measure Information:
Title
Revised Dyadic Adjustment Scale (RDAS)
Description
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.
Time Frame
Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Secondary Outcome Measure Information:
Title
Brief Symptom Inventory-18 (BSI)
Description
The Brief Symptom Inventory-18 (BSI-18) is an 18 item self-report instrument designed to quantify psychological distress in the general population. Increasingly, the measure has been used to quantify individuals and family members' distress after ABI. The instrument is a psychometrically sound, abbreviated version of the SCL-90-R. Frequency ratings for items in three primary symptom dimensions are added to yield scores for Somatization, Depression, and Anxiety. The Global Severity Index (GSI) reflects the sum of scores for the three symptom dimensions. T-scores for each dimension and the GSI are calculated based on community norms. GSI scores, reflecting overall distress levels, will be used in the present investigation.
Time Frame
Change from Baseline to Post-Treatment (5-6 weeks after Baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Kreutzer, PhD
Organizational Affiliation
Professor, Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31855018
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. 2019 Dec 19. doi: 10.1037/rep0000300. Online ahead of print.
Results Reference
derived

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

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