Chronic Insomnia
Conditions
Brief summary
The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.
Interventions
This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week * Above Criteria occurring every week for greater than or equal to 3 months * At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired) * Able to provide valid consent * Willing to participate in an internet-based cognitive behavioral therapy for insomnia * English speaking
Exclusion criteria
* Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder * Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation) * Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine. * Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (Total), Change From Baseline to Follow-up | pre-intervention, intervention completion (expected average of 7 weeks) | Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia. |
| Completion of All 7 Modules of the Intervention | on average 7 weeks | Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program. |
Countries
United States
Participant flow
Recruitment details
100 Individuals were recruited between October 2013 and May 2014.
Pre-assignment details
A single subject completed informed consent procedures and signed the informed consent document, but then was found not to meet exclusion criteria on review of the medical record. The individual was disenrolled.
Participants by arm
| Arm | Count |
|---|---|
| Internet-based Cognitive Behavioral Therapy for Insomnia This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Internet-based Cognitive Behavioral Therapy for Insomnia |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized African American | 19 participants |
| Race/Ethnicity, Customized Other Race/Ethnicity | 5 participants |
| Race/Ethnicity, Customized White | 27 participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Completion of All 7 Modules of the Intervention
Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program.
Time frame: on average 7 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Internet-based Cognitive Behavioral Therapy for Insomnia | Completion of All 7 Modules of the Intervention | 21 participants |
Primary
Insomnia Severity Index (Total), Change From Baseline to Follow-up
Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia.
Time frame: pre-intervention, intervention completion (expected average of 7 weeks)
Population: The number of individuals provided access to the program and reporting baseline and follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet-based Cognitive Behavioral Therapy for Insomnia | Insomnia Severity Index (Total), Change From Baseline to Follow-up | 6.3 units on a scale | Standard Deviation 2.3 |