Insomnia Comorbid to Psychiatric Disorder, Primary Insomnia
Conditions
Brief summary
Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared the psychological/behavioral therapies and BzRAs for insomnia treatment. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more clinically relevant indicators of remission. Finally, studies have yet to test the benefits of treatment sequencing for those who do not respond to initial their insomnia therapy. This multi-site project will address these limitations. Two study sites will enroll a total of 224 participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder. Participants will be evaluated with clinical assessments and PSG, and then will be randomly assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT) or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered re-randomization to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score \< 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our over-arching goal is to obtain new information that aids in the development of clinical guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.
Interventions
BEHAVIORALBehavioral Insomnia Therapy
Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
DRUGZolpidem
5mg or 10mg
DRUGTrazodone
50mg to 150mg
BEHAVIORALCognitive Therapy
Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions.
Sponsors
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Jack Edinger, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a complaint of persistent (i.e., \> 1 month) difficulties initiating or maintaining sleep despite adequate opportunity for sleep; * a sleep onset latency or wake time after sleep onset \> 30 minutes 3 or more nights per week during two weeks sleep diary monitoring; * an Insomnia Severity Index (ISI) score \> 10 indicating at least mild insomnia; and * a score ≥ 2 on either the interference or distress item of the screening ISI, indicating the insomnia causes significant distress or impairment in social, occupational, or other areas of functioning. These criteria represent those provided in the DSM-IV-TR87, Research Diagnostic Criteria3 and the International Classification of Sleep Disorders4, and will ensure a sample with clinically relevant insomnia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months | The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-drug Sleep Therapy 1 Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions. | 104 |
| Sleep Medication 1 Zolpidem: 5mg or 10mg | 107 |
| Total | 211 |
Baseline characteristics
| Characteristic | Sleep Medication 1 | Total | Non-drug Sleep Therapy 1 |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 15.5 | 45.6 years STANDARD_DEVIATION 14.9 | 45.9 years STANDARD_DEVIATION 14.4 |
| Race/Ethnicity, Customized Black | 8 Participants | 14 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 12 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 93 Participants | 187 Participants | 94 Participants |
| Sex: Female, Male Female | 68 Participants | 132 Participants | 64 Participants |
| Sex: Female, Male Male | 39 Participants | 79 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 134 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 131 | 0 / 134 | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 131 | 0 / 134 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index
The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8.
Time frame: 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-drug Sleep Therapy 1 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 40.00 percent remitted |
| Sleep Medication 1 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 34.94 percent remitted |
| Sleep Medication 1 Plus Non-drug Sleep Therapy 1 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 37.04 percent remitted |
| Sleep Medication 1 Plus Sleep Medication 2 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 48.15 percent remitted |
| Non-drug Sleep Therapy 1 Plus Non-drug Sleep Therapy 1 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 44.44 percent remitted |
| Non-drug Sleep Therapy 1 Plus Sleep Medication 1 | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 55.56 percent remitted |