Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

May 12, 2014 updated by: Rachel Manber, Stanford University
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Drug: Escitalopram
5 to 20 mg for 12 weeks
Other Names:
  • Escitalopram plus Cognitive behavioral Therapy
  • Escitalopram plus Pseudo-desensitization Therapy
Behavioral: CBTI
Cognitive Behavioral Treatment for Insomnia
Other Names:
  • Cognitive Behavioral Treatment for Insomnia
Active Comparator: MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Drug: Escitalopram
5 to 20 mg for 12 weeks
Other Names:
  • Escitalopram plus Cognitive behavioral Therapy
  • Escitalopram plus Pseudo-desensitization Therapy
Behavioral: CTRL
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Other Names:
  • Pseudo-desensitization Therapy for Insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of Depression (%)
Time Frame: After 12 weeks or at the last available time point

Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.

The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.

The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).
After 12 weeks or at the last available time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of Insomnia
Time Frame: After 12 weeks or at the last available time point
Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.
After 12 weeks or at the last available time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Rachel Manber, PhD, Stanford University Medical School, Department of Psychiatry and Behavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH066131 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAS (NIMH Program Class Code)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe