Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
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|ClinicalTrials.gov Identifier: NCT00149825|
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 14, 2009
Last Update Posted : May 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Insomnia||Drug: Escitalopram Behavioral: CBTI Behavioral: CTRL||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||June 2004|
|Primary Completion Date :||August 2007|
|Study Completion Date :||August 2007|
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
5 to 20 mg for 12 weeks
Other Names:Behavioral: CBTI
Cognitive Behavioral Treatment for Insomnia
Other Name: Cognitive Behavioral Treatment for Insomnia
Active Comparator: MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
5 to 20 mg for 12 weeks
Other Names:Behavioral: CTRL
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Other Name: Pseudo-desensitization Therapy for Insomnia
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149825
|United States, California|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Rachel Manber, PhD||Stanford University Medical School, Department of Psychiatry and Behavioral Sciences|