Back to resultsCombining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Primary Purpose
Major Depressive Disorder, Insomnia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
CBTI
CTRL
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Insomnia, Sleep, Mental Health
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 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)
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MED+CBTI
MED+CTRL
Arm Description
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00149825
First Posted
September 6, 2005
Last Updated
May 12, 2014
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00149825
Brief Title
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Insomnia
Keywords
Major Depressive Disorder, Insomnia, Sleep, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MED+CBTI
Arm Type
Experimental
Arm Description
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Arm Title
MED+CTRL
Arm Type
Active Comparator
Arm Description
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Escitalopram plus Cognitive behavioral Therapy, Escitalopram plus Pseudo-desensitization Therapy
Intervention Description
5 to 20 mg for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
CBTI
Other Intervention Name(s)
Cognitive Behavioral Treatment for Insomnia
Intervention Description
Cognitive Behavioral Treatment for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
CTRL
Other Intervention Name(s)
Pseudo-desensitization Therapy for Insomnia
Intervention Description
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Primary Outcome Measure Information:
Title
Remission of Depression (%)
Description
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).
Time Frame
After 12 weeks or at the last available time point
Secondary Outcome Measure Information:
Title
Remission of Insomnia
Description
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.
Time Frame
After 12 weeks or at the last available time point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Manber, PhD
Organizational Affiliation
Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19616140
Citation
Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25.
Results Reference
background
PubMed Identifier
18457236
Citation
Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. doi: 10.1093/sleep/31.4.489.
Results Reference
result
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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
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