Cognitive Therapy for Recurrent Depression

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Other: Continuation phase pill placebo; Behavioral: Continuation phase cognitive therapy; Drug: Continuation phase fluoxetine; Behavioral: Acute phase cognitive therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00118404

R01MH058356 (U.S. NIH Grant/Contract)

R01MH069618 (U.S. NIH Grant/Contract)

R01MH058397 (U.S. NIH Grant/Contract)

R01MH069619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 523 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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523 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Participants received acute phase and continuation phase cognitive therapy

Treatment:

Behavioral: Acute phase cognitive therapy

Behavioral: Continuation phase cognitive therapy

2

Placebo Comparator group

Description:

Participants received acute phase cognitive therapy and continuation phase pill placebo

Treatment:

Other: Continuation phase pill placebo

Behavioral: Acute phase cognitive therapy

3

Active Comparator group

Description:

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Treatment:

Behavioral: Acute phase cognitive therapy

Drug: Continuation phase fluoxetine