Treatment for Chronic Depression
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|ClinicalTrials.gov Identifier: NCT00204152|
Recruitment Status : Terminated (PI left U of C)
First Posted : September 20, 2005
Last Update Posted : September 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation||Phase 3|
Early-onset unipolar major depression is linked with considerable morbidity and mortality (Birmaher et al., 1996). The goal of this project is to test the efficacy of Behavioral Activation (BA; Jacobson et al., 2001) and an integrated version of Behavioral Activation (BA + Stress Inoculation Coping; BASIC) for the short-term psychotherapy of adults with chronic major depression (onset before age 18) and a history of early life stress before age 18. Exposure to stress during the developmental years has been linked with early-onset depression (Rao et al., 1996), a propensity to generate stress during the life span (Hammen et al., 1998), and a greater psychological sensitivity to stress as an adult (Post et al., 1992). And while incidence of early life stress is high among depressed adults, there are no behavioral treatments designed to address the unique needs of these individuals. We aim to develop a new treatment for a specific group of depressed patients, namely individuals who report early onset of depression and early life stress. We include the critical elements of behavioral activation and stress reduction strategies to address the avoidance, stress sensitivities, and coping deficits often observed in this population.
The specific aims are: 1) to determine if the addition of stress reduction strategies (packaged in BASIC) enhance the effects of BA, as indexed by the rate early remission; 2) to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination, as indexed by reduced rates of relapse by the 3-month follow-up; and, 3) to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills, and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills. Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA (control condition) using a randomized clinical trial design to distinguish between conditions. We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response. We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Treatment for Chronic Depression With Behavioral Interventions|
|Study Start Date :||June 2004|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
- severity of depression, measured by Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al., 1982; Keller et al., 1987), Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996a), and Hamilton Rating Scale for Depression.
- Cognitive functioning, social/behavioral functioning, and stress regulation.
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): NCT00204152
|United States, Illinois|
|The University of Chicago, Department of Psychiatry|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Jackie K Gollan, Ph.D.||The University of Chicago, Department of Psychiatry|