Comparative efficacy and durability of continuation phase cognitive therapy for preventing recurrent depression: Design of a double-blinded, fluoxetine- and pill placebo-controlled, randomized trial with 2-year follow-up
Open accessAbstract
Background Major Depressive Disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower vs. higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24 months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12-14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression <or=12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (n=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide.
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- Authors
- Jarrett, R. B., & Thase, M. E.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Veterans Health Administration (US)
- Corresponding author
- Jarrett, Robin B.
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2010-07
- Volume
- 31
- Issue
- 4
- Pages
- 355-377
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC2936266
- OpenAlex
- W2035003660
- Cited by
- 51
- References
- 20
- Citations by year
- 2023: 1 · 2021: 4 · 2020: 3 · 2019: 5 · 2018: 5 · 2017: 3 · 2016: 3 · 2015: 5 · 2014: 6 · 2013: 7 · 2012: 4
- FWCI
- 3.77
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (R01 MH58356, R01MH069618, R01 MH-69219, R01 MH-58397, R01MH069619, L40 MH069219, R01MH69618, K24MH001571, R01MH058397, R01MH058356)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- cognitive therapy, recurrent major depressive disorder, relapse prevention, recurrence risk stratification, fluoxetine, treatment durability, depression prevention
- MeSH terms
- Adolescent, Adult, Aged, Depressive Disorder, Major, Major Depressive Disorder, Double-Blind Method, Female, Fluoxetine, Follow-Up Studies, Humans, Male, Middle Aged, Research Design, Cognitive Behavioral Therapy, Antidepressive Agents, Second-Generation, Secondary Prevention, Young Adult
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