Prophylactic Cognitive Therapy for Depression.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 523
- Locations
- 2
- Primary Endpoint
- Depressive Relapse or MDD
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Participants received acute phase and continuation phase cognitive therapy
Intervention: Continuation phase cognitive therapy (Behavioral)
1
Participants received acute phase and continuation phase cognitive therapy
Intervention: Acute phase cognitive therapy (Behavioral)
2
Participants received acute phase cognitive therapy and continuation phase pill placebo
Intervention: Continuation phase pill placebo (Other)
2
Participants received acute phase cognitive therapy and continuation phase pill placebo
Intervention: Acute phase cognitive therapy (Behavioral)
3
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Intervention: Continuation phase fluoxetine (Drug)
3
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Intervention: Acute phase cognitive therapy (Behavioral)
Outcomes
Primary Outcomes
Depressive Relapse or MDD
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Robin Jarrett
Professor of Psychiatry
University of Texas Southwestern Medical Center