Cognitive Therapy for Recurrent Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylactic Cognitive Therapy for Depression.

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Continuation phase cognitive therapy
* Drug: Continuation phase fluoxetine
* Other: Continuation phase pill placebo
* Behavioral: Acute phase cognitive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants received acute phase and continuation phase cognitive therapy | Behavioral: Continuation phase cognitive therapy<br>* Continuation phase cognitive therapy included 10 sessions over 8 months.<br>Behavioral: Acute phase cognitive therapy<br>* For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.<br>|
| Placebo Comparator: 2<br>Participants received acute phase cognitive therapy and continuation phase pill placebo | Other: Continuation phase pill placebo<br>* The dosage of pill placebo was increased to 40 mg over 8 months.<br>Behavioral: Acute phase cognitive therapy<br>* For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.<br>|
| Active Comparator: 3<br>Participants received acute phase cognitive therapy and continuation phase fluoxetine | Drug: Continuation phase fluoxetine<br>* The dosage of fluoxetine was increased to 40 mg over 8 months.<br>* Other names: Prozac;Behavioral: Acute phase cognitive therapy<br>* For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Relapse or MDD | 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: = No residual symptoms, no current evidence of the disorder. = Mild symptoms = Considerably less psychopathology than full criteria with no more than moderate impairment = Does not meet full criteria but has major symptoms of impairment = Meets criteria without extreme impairment in functioning = 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) | Measured at month 8 | 
| Depressive Relapse/Recurrence or MDD | 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: = No residual symptoms, no current evidence of the disorder. = Mild symptoms = Considerably less psychopathology than full criteria with no more than moderate impairment = Does not meet full criteria but has major symptoms of impairment = Meets criteria without extreme impairment in functioning = 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) | Measured at month 20 | 
| Depressive Relapse/Recurrence or MDD | 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: = No residual symptoms, no current evidence of the disorder. = Mild symptoms = Considerably less psychopathology than full criteria with no more than moderate impairment = Does not meet full criteria but has major symptoms of impairment = Meets criteria without extreme impairment in functioning = 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). | Measured at month 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive therapy, Antidepressants, Psychotherapy