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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH066131 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATAS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MED+CBTI | Experimental | Escitalopram plus Cognitive Behavioral Therapy for Insomnia |
|
| MED+CTRL | Active Comparator | Escitalopram plus Pseudo-desensitization Therapy for Insomnia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 5 to 20 mg for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Manber, PhD | Stanford University Medical School, Department of Psychiatry and Behavioral Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19616140 | Background | 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. | |
| 18457236 | Result | 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. |
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Enrolled participants were screened to determine if inclusion exclusion criteria were met. This process included structured clinical interviews, completion of sleep logs, and an ambulatory screening sleep study to rule out other sleep disorders.
Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | MED+CBTI | Escitalopram plus cognitive behavioral therapy for insomnia |
| FG001 | MED+CTRL | Escitalopram plus control therapy for insomnia in depression |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MED+CBTI | Escitalopram plus cognitive behavioral therapy for insomnia |
| BG001 | MED+CTRL | Escitalopram plus control therapy for insomnia in depression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | percent of participants | After 12 weeks or at the last available time point |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MED+CBTI | Escitalopram plus cognitive behavioral therapy for insomnia |
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Limitations of the current pilot study include a small sample size, relative racial homogeneity, and exclusion of patients with comorbidity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Manber, PhD | Stanford University, School of Medicine | 650-724-2377 | Rmanber@stanford.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| CBTI | Behavioral | Cognitive Behavioral Treatment for Insomnia |
|
|
| CTRL | Behavioral | Control Therapy consists of Pseudo-desensitization Therapy for Insomnia |
|
|
| Not liking insomnia therapy |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Escitalopram plus control therapy for insomnia in depression |
|
|
|
| Secondary | 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. | Included in the analysis were all participants who attended at least one post randomization visit. | Posted | Number | percent | After 12 weeks or at the last available time point |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 13 |
| EG001 | MED+CTRL | Escitalopram plus control therapy for insomnia in depression | 0 | 0 | 0 | 15 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |