Insomnia, Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Insomnia, Sleep, Mental Health
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.
Interventions
Sponsors
National Institute of Mental Health (NIMH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| MED+CBTI Escitalopram plus cognitive behavioral therapy for insomnia | 15 |
| MED+CTRL Escitalopram plus control therapy for insomnia in depression | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Intolerance to medication side effects | 1 | 2 |
| Overall Study | Not liking insomnia therapy | 1 | 0 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Time commitments | 2 | 1 |
Baseline characteristics
| Characteristic | MED+CTRL | MED+CBTI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Continuous | 47.8 years STANDARD_DEVIATION 13.4 | 49.5 years STANDARD_DEVIATION 13.6 | 48.6 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: After 12 weeks or at the last available time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MED+CBTI | Remission of Depression (%) | 61.5 percent of participants |
| MED+CTRL | Remission of Depression (%) | 33.3 percent of participants |
Comparison: We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depressionp-value: 0.13Chi-squared
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.
Time frame: After 12 weeks or at the last available time point
Population: Included in the analysis were all participants who attended at least one post randomization visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MED+CBTI | Remission of Insomnia | 50.0 percent |
| MED+CTRL | Remission of Insomnia | 7.7 percent |
Comparison: We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.p-value: 0.05Chi-squared