Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-08-31

Brief Summary

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This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

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Detailed Description

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Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.

Conditions

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Major Depressive Disorder Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MED+CBTI

Escitalopram plus Cognitive Behavioral Therapy for Insomnia

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

5 to 20 mg for 12 weeks

CBTI

Intervention Type BEHAVIORAL

Cognitive Behavioral Treatment for Insomnia

MED+CTRL

Escitalopram plus Pseudo-desensitization Therapy for Insomnia

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

5 to 20 mg for 12 weeks

CTRL

Intervention Type BEHAVIORAL

Control Therapy consists of Pseudo-desensitization Therapy for Insomnia

Interventions

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Escitalopram

5 to 20 mg for 12 weeks

Intervention Type DRUG

CBTI

Cognitive Behavioral Treatment for Insomnia

Intervention Type BEHAVIORAL

CTRL

Control Therapy consists of Pseudo-desensitization Therapy for Insomnia

Intervention Type BEHAVIORAL

Other Intervention Names

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Escitalopram plus Cognitive behavioral Therapy Escitalopram plus Pseudo-desensitization Therapy Cognitive Behavioral Treatment for Insomnia Pseudo-desensitization Therapy for Insomnia

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of major depressive disorder
* HRSD(17) score of at least 14
* Presence and complaint of insomnia for at least 1 month
* Fluent in English
* Use of an effective form of contraception throughout the study

Exclusion Criteria

* Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
* Psychotic symptoms
* Serious, unstable, or terminal medical condition
* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
* Substance abuse
* Not willing to end other psychiatric treatment
* Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
* Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
* Other sleep disorders
* Currently pregnant or breastfeeding
* History of seizure disorder
* Disease or condition that produces altered metabolism or hemodynamic responses
* Liver or kidney dysfunction
* Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No