Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2001-11-30
2009-06-30
Brief Summary
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Detailed Description
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Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine \[Effexor\] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.
Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1 Sertraline/Venlafaxine
Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
Sertraline
Participants will receive sertraline.
Venlafaxine
Participants will receive venlafaxine.
2 Supportive Expressive Therapy
Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy
The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
3 Pill Placebo
Participants receive placebo.
Pill Placebo
Participants will receive a pill placebo.
Interventions
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Supportive Expressive Therapy
The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
Sertraline
Participants will receive sertraline.
Pill Placebo
Participants will receive a pill placebo.
Venlafaxine
Participants will receive venlafaxine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Substance dependence in the last 6 months
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Jacques Barber, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996 Oct;64(5):951-8. doi: 10.1037//0022-006x.64.5.951.
Kuprian N, Aafjes-van Doorn K, Gutterman D, Barber JP. Therapeutic immediacy in psychodynamic psychotherapy for depression: A mixed-method study. Psychotherapy (Chic). 2022 Dec;59(4):554-566. doi: 10.1037/pst0000452. Epub 2022 Aug 1.
Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.
Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.
Zilcha-Mano S, Keefe JR, Chui H, Rubin A, Barrett MS, Barber JP. Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations. J Clin Psychiatry. 2016 Dec;77(12):e1584-e1590. doi: 10.4088/JCP.15m10081.
Zilcha-Mano S, Dinger U, McCarthy KS, Barrett MS, Barber JP. Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder. J Affect Disord. 2014 Jan;152-154:538-42. doi: 10.1016/j.jad.2013.10.015. Epub 2013 Oct 16.
Barber JP, Barrett MS, Gallop R, Rynn MA, Rickels K. Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Jan;73(1):66-73. doi: 10.4088/JCP.11m06831. Epub 2011 Nov 29.
Other Identifiers
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