Traumatic Brain InjuryNCT04192227
Comparison of Two Group Wellness Interventions in TBI Partner Caregivers
A study testing EnHAncing BehavIors through wellness TreatmentS (HABITS) in people with Traumatic Brain Injury and Partner Caregiver, run by Kessler Foundation at 2 sites in United States.
Trial summary
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Partner Caregiver
- What is being tested?
- EnHAncing BehavIors through wellness TreatmentS (HABITS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2019to 31 Oct 2022
- 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
- at least 18 years of age.
- read and speak English fluently.
- have been in an intimate relationship with a person with TBI for at least one year prior to their injury.
- partner was discharged from inpatient rehabilitation at least 3 months ago.
- provide care to partner on a daily basis.
- have access to the internet in a private location.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kessler Foundation
East Hanover, New Jersey, 07936
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
Official title: Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.
Read the detailed description
A multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). 92 participants will be recruited. Participants are randomly assigned to one of two wellness groups. Each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. Participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. Intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.
- Conditions
- Traumatic Brain Injury, Partner Caregiver
- Being tested
- EnHAncing BehavIors through wellness TreatmentS (HABITS)
- Keywords
- Spouse, Partner, Caregivers, Brain Injuries
- 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.
EnHAncing BehavIors through wellness TreatmentS (HABITS)Behavioural
Six 75-minute sessions via live video conference wherein participants will receive training in areas of health, wellness and quality of life. Classes will be supplemented with independent homework assignments and discussion on a closed social media forum with peers and facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Wellness Group 1 | Experimental | Administered by wellness facilitator and co-facilitator. Receives: Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS) |
| Wellness Group 2 | Active comparator | Administered by wellness facilitator and co-facilitator. Receives: Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Behavioral Inhibition Scale (BIS)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Measured: 6 weeks (between pre- and post testing)
Change on Behavioral Activation Scale (BAS)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.
Measured: 6 weeks (between pre- and post testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Dec 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana
- Responsible party
- Principal investigator, Denise Krch, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192227
- Sponsor's protocol ID
- E-1076-19
- Status last verified
- Jun 2023
- First submitted
- 5 Dec 2019
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04192227
- Acronym / sponsor ID
- E-1076-19
- Conditions
- Traumatic Brain Injury, Partner Caregiver
- Keywords
- Spouse, Partner, Caregivers, Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- 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.
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.
Detailed description
A multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). 92 participants will be recruited. Participants are randomly assigned to one of two wellness groups. Each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. Participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. Intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness Group 1 | Experimental | Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)Administered by wellness facilitator and co-facilitator. |
| Wellness Group 2 | Active comparator | Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)Administered by wellness facilitator and co-facilitator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age.
- read and speak English fluently.
- have been in an intimate relationship with a person with TBI for at least one year prior to their injury.
- partner was discharged from inpatient rehabilitation at least 3 months ago.
- provide care to partner on a daily basis.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EnHAncing BehavIors through wellness TreatmentS (HABITS)Six 75-minute sessions via live video conference wherein participants will receive training in areas of health, wellness and quality of life. Classes will be supplemented with independent homework assignments and discussion on a closed social media forum with peers and facilitators. | Behavioural | Wellness Group 1, Wellness Group 2 |
Primary outcome
Change on Behavioral Inhibition Scale (BIS)
Time frame: 6 weeks (between pre- and post testing)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Change on Behavioral Activation Scale (BAS)
Time frame: 6 weeks (between pre- and post testing)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.
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 12 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnHAncing BehavIors through wellness TreatmentS (HABITS) in people with Traumatic Brain Injury and Partner Caregiver, run by Kessler Foundation at 2 sites 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 6 inclusion and 0 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change on Behavioral Inhibition Scale (BIS) (time frame: 6 weeks (between pre- and post testing)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.