Cognitive Therapy for Recurrent Depression

Phase 3

Completed

• Conditions: Depression
• Interventions: Behavioral: Continuation phase cognitive therapy; Drug: Continuation phase fluoxetine; Other: Continuation phase pill placebo; Behavioral: Acute phase cognitive therapy

• Registration Number: NCT00118404
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Detailed Description

Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

This study lasted approximately 36 months and comprised three phases. For the first 12 weeks, all participants received between 16 and 20 CT sessions. Participants were then randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2005-07-06
• Study First Submitted QC: 2005-07-06
• Study First Posted: 2005-07-11
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2013-12-12
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Results First Posted: 2014-06-05
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

Inclusion Criteria

• Recurrent unipolar major depressive disorder
• Have experienced at least two episodes of major depression
• Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
• Willing and able to comply with all study requirements
• Able to speak and read English

Exclusion Criteria

• Active alcohol or other substance dependence within 6 months prior to study entry
• Currently at risk for suicide
• Mood disorders due to a medical condition or substance abuse
• Bipolar, schizoaffective, obsessive compulsive, or eating disorders
• Schizophrenia
• Unable to stop mood-altering medications
• Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
• Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
• Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
• Pregnancy or plan to become pregnant in the next 11-12 months
• Unable to attend clinic twice weekly during business hours
• Unable to complete questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Acute phase cognitive therapy	Participants received acute phase cognitive therapy and continuation phase pill placebo
1	Acute phase cognitive therapy	Participants received acute phase and continuation phase cognitive therapy
1	Continuation phase cognitive therapy	Participants received acute phase and continuation phase cognitive therapy
3	Continuation phase fluoxetine	Participants received acute phase cognitive therapy and continuation phase fluoxetine
2	Continuation phase pill placebo	Participants received acute phase cognitive therapy and continuation phase pill placebo
3	Acute phase cognitive therapy	Participants received acute phase cognitive therapy and continuation phase fluoxetine

Primary Outcome Measures

Name	Time	Method
Depressive Relapse or MDD	Measured at month 8	Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment; LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder.; 2. = Mild symptoms; 3. = Considerably less psychopathology than full criteria with no more than moderate impairment; 4. = Does not meet full criteria but has major symptoms of impairment; 5. = Meets criteria without extreme impairment in functioning; 6. = Meets criteria with extreme impairment in functioning; The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)
Depressive Relapse/Recurrence or MDD	Measured at month 32	Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment; LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder.; 2. = Mild symptoms; 3. = Considerably less psychopathology than full criteria with no more than moderate impairment; 4. = Does not meet full criteria but has major symptoms of impairment; 5. = Meets criteria without extreme impairment in functioning; 6. = Meets criteria with extreme impairment in functioning; Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481).

Trial Locations

Locations (2)

University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States