Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Study Overview
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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.

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

Intervention / Treatment
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* Drug: Escitalopram
* Behavioral: CBTI
* Behavioral: CTRL


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MED+CBTI<br>Escitalopram plus Cognitive Behavioral Therapy for Insomnia | Drug: Escitalopram<br>* 5 to 20 mg for 12 weeks<br>* Other names: Escitalopram plus Pseudo-desensitization Therapy;Behavioral: CBTI<br>* Cognitive Behavioral Treatment for Insomnia<br>* Other names: Cognitive Behavioral Treatment for Insomnia;|
| Active Comparator: MED+CTRL<br>Escitalopram plus Pseudo-desensitization Therapy for Insomnia | Drug: Escitalopram<br>* 5 to 20 mg for 12 weeks<br>* Other names: Escitalopram plus Pseudo-desensitization Therapy;Behavioral: CTRL<br>* Control Therapy consists of Pseudo-desensitization Therapy for Insomnia<br>* Other names: Pseudo-desensitization Therapy for Insomnia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of Depression (%) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Insomnia, Sleep, Mental Health