Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Overview
- Phase
- Phase 2
- Intervention
- Escitalopram
- Conditions
- Major Depressive Disorder
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Remission of Depression (%)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
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.
Investigators
Rachel Manber
Dr. Rachel Manber
Stanford University
Eligibility Criteria
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
Arms & Interventions
MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Intervention: Escitalopram
MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Intervention: CBTI
MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Intervention: Escitalopram
MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Intervention: CTRL
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Remission of Insomnia(After 12 weeks or at the last available time point)