Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
MED+CBTI	CBTI	Escitalopram plus Cognitive Behavioral Therapy for Insomnia
MED+CTRL	CTRL	Escitalopram plus Pseudo-desensitization Therapy for Insomnia
MED+CBTI	Escitalopram	Escitalopram plus Cognitive Behavioral Therapy for Insomnia
MED+CTRL	Escitalopram	Escitalopram plus Pseudo-desensitization Therapy for Insomnia

Primary Outcome Measures

Name	Time	Method
Remission of Depression (%)	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 Outcome Measures

Name	Time	Method
Remission of Insomnia	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.