Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT03307070|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : September 1, 2020
The first aim of this study is to develop a structured, cognitive behavioral treatment manual for major depressive disorder (MDD) adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBTx-TBI), as well as evaluate its acceptability and tolerability in an open 12-week pilot trial (N=10).
The second aim is to evaluate the acceptability and tolerability of, and adherence to, CBTx-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40).
A third, exploratory aim is to evaluate the potential efficacy of CBTx-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Traumatic Brain Injury||Behavioral: Cognitive Behavioral Therapy for individuals with TBI Other: Waitlist Control||Not Applicable|
The primary aim of this study is to develop a highly acceptable, manualized treatment (CBTx-TBI) for MDD in patients with moderate to severe TBI. After developing the manual (Phase 1), a nonrandomized trial (Phase 2) will be conducted to test its acceptability and tolerability. Based on objective and qualitative feedback from participants and input from mentors and consultants, the CBTx-TBI manual will be revised (Phase 3). The investigators will then pilot test the efficacy of the intervention to reduce depressive symptoms (IDS-C) after 12 weeks using the revised CBTx-TBI manual compared to a waitlist control group in a randomized pilot trial (Phase 4). Once the randomized pilot study is complete, the CBTx-TBI manual will be finalized with additional feedback from subjects, mentors, and therapists.
For both phases of recruitment, the same study procedures will be used (unless procedures are modified in Phase 3). The proposed study involves the following points of contact: (1) Obtaining informed consent and screening (may be broken up into multiple visits), (2) biweekly clinician assessments of depressive and neuropsychiatric symptoms (weeks 2, 4, 6, 8, 10), (3) weekly self-report assessments of depressive symptoms for those receiving the intervention, (4) 12 weekly individual CBTx-TBI sessions for those randomized to the intervention, (5) a comprehensive assessment at week 12 (primary endpoint), which includes the neuropsychological battery, and (6) a 3-month follow-up assessment for those who received the intervention (randomized pilot only, phase 4). Assessment visits during the 12 weeks of treatment may be completed by phone. The week 12 visit can be split into two parts, with the neuropsychological assessment occurring during the second part, in order to accommodate subjects' potential limitations due to fatigue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Phase I of the study is an open trial with a single arm. Phase II of the study is a randomized, waitlist controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury|
|Actual Study Start Date :||September 23, 2017|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Active Comparator: Active Group
Participants who are randomized to begin the Cognitive Behavioral Therapy for individuals with TBI immediately after screening. This treatment is a version of Cognitive Behavioral Therapy (CBT) adapted specifically for patients who have experienced a moderate to severe Traumatic Brain Injury (TBI).
Behavioral: Cognitive Behavioral Therapy for individuals with TBI
Cognitive Behavioral Therapy for depression that has been adapted for a population who has experienced a moderate to severe Traumatic Brain Injury. This is a 12 week long treatment for depression with weekly visits that challenges negative thoughts and behaviors. This version has been specifically developed for the study to account for specific cognitive needs of individuals who have experienced a moderate to severe TBI.
Participants who are randomized to be put on a waitlist after screening. After 12 weeks of being on the waitlist, participants will be offered the Cognitive Behavioral Therapy for individuals with TBI
Other: Waitlist Control
Participants will be randomized to a waitlist. They will attend biweekly study sessions for 12 weeks to track progress, but will receive their treatment as usual.
- QIDS-C [ Time Frame: administered biweekly for 12 weeks ]A 16-item, clinician rated scale assessing depression symptom severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307070
|Contact: Sylvie Tuchman, BAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Garrett Thomas 617-724-3222 firstname.lastname@example.org|
|Principal Investigator:||Lauren B Fisher, PHD||Massachusetts General Hospital|