Traumatic Brain InjuryNCT01935609
Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples
A study testing Couples counseling in people with Traumatic Brain Injury and Acquired Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acquired Brain Injury
- What is being tested?
- Couples counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 28 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples (a Research Project Within the Traumatic Brain Injury Model System Grant)
- 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.
Read the 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
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury
- Being tested
- Couples counseling
- Keywords
- traumatic brain injury, acquired brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Secondary outcomes (1)
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.
Measured: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startMar 2013
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Kreutzer, PhD, Principal investigator, Professor, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935609
- Sponsor's protocol ID
- HM14736
- Other IDs
- H133A120031
- Status last verified
- Oct 2017
- First submitted
- 21 Aug 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31855018
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Skill-Building, Supportive, and Educational Intervention for Couples (a Research Project Within the Traumatic Brain Injury Model System Grant)
- ClinicalTrials.gov ID
- NCT01935609
- Acronym / sponsor ID
- HM14736
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury
- Keywords
- traumatic brain injury, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Mar 2013
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples counseling | Experimental | Behavioral: Couples counselingIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples counselingIntervention 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. | Behavioural | Couples counseling |
Primary outcome
Revised Dyadic Adjustment Scale (RDAS)
Time frame: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
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.
1 secondary outcome
Brief Symptom Inventory-18 (BSI)
Time frame: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 31855018Graham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Kreutzer, PhD principal investigator
Professor, Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples counseling in people with Traumatic Brain Injury and Acquired Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Dyadic Adjustment Scale (RDAS) (time frame: Change from Baseline to Post-Treatment (5-6 weeks after Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.