Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Stanford University

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Insomnia

Treatments: Behavioral: CBTI; Drug: Escitalopram; Behavioral: CTRL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00149825

DSIR 83-ATAS

R21MH066131 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

MED+CBTI

Experimental group

Description:

Escitalopram plus Cognitive Behavioral Therapy for Insomnia

Treatment:

Drug: Escitalopram

Behavioral: CBTI

MED+CTRL

Active Comparator group

Description:

Escitalopram plus Pseudo-desensitization Therapy for Insomnia

Treatment:

Behavioral: CTRL

Drug: Escitalopram