Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00878150
Brief Summary:
The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).
Detailed Description:
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute.
There are also multiple barriers to effective treatment of MDD in persons with TBI, including:
* under-diagnosis and under-treatment 20lack of access to care due to mobility, transportation and health care benefit limitations
* TBI neurocognitive impairments
* comorbid medical and psychiatric problems, including substance abuse
* stressors such as lack of social support and work instability
* inaccurate beliefs about depression and its treatment among TBI survivors.
The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.
The investigators project aims are to
1. develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone
2. conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual
3. refine the intervention and plan a definitive RCT of CBT-TBI if response rate is sufficient.
Participants are randomized to one of three groups: (1) 12 semi-weekly sessions of telephone-based CBT for depression provided by a study therapist, (2) 12 semi-weekly sessions of in-person CBT for depression provided by a study therapist, or (3) Usual Care (control). Randomization is stratified by injury severity to ensure equal proportions in each treatment group. Participants choose one of three randomization options that includes the groups to which he/she would like to be randomized:
* Option 1: Telephone counseling verses usual care
* Option 2: In-person counseling verses usual care
* Option 3: In-person counseling verses Telephone counseling verses usual care
Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline.
Study:
NCT00878150
Study Brief:
Protocol Section:
NCT00878150