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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00211835
Brief Summary:
Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.
Detailed Description:
Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression.
Examine the relationship between improved mood, participation, and life satisfaction.
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment.
Maximize potential application to clinical practice by:
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.
Study:
NCT00211835
Study Brief:
Protocol Section:
NCT00211835