Insomnia, Insomnia Disorder
Conditions
Keywords
insomnia, online systems
Brief summary
Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia. Design This is a randomized controlled trial with online treatment and waiting list control conditions. Participants Participants are adults in Manitoba Canada with chronic insomnia. Setting Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
Interventions
BEHAVIORALCognitive Behavioral Therapy
6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Access to high speed internet, insomnia duration \> 6 months and occurring at least 4 nights per week, sleep-onset latency \> 30 minutes and/or time awake at night \> 30 minutes, and/or early morning awakening \> 30 minutes before desired time, at least one type of daytime impairment.
Exclusion criteria
* Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake \> 14 drinks/week for males, \> 12 drinks per week for females, current or past behavioral treatment for insomnia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 6 weeks | Sleep Quality was assessed by taking the average of two items: How well do you feel this morning? And How enjoyable was your sleep last night? (0 = not at all, 4 = very). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Sleep Arousal | 6 weeks | Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. |
| Beliefs and Attitudes About Sleep | 6 weeks | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Waiting List Control | 59 |
| Cognitive Behavioral Therapy | 59 |
| Total | 118 |
Baseline characteristics
| Characteristic | Waiting List Control | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Age Continuous | 50.45 Years STANDARD_DEVIATION 13.26 | 48.56 Years STANDARD_DEVIATION 11.39 | 49.54 Years STANDARD_DEVIATION 12.32 |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 39 Participants |
| Total Sleep Time | 5.54 Hours | 5.61 Hours | 5.58 Hours |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Sleep Quality
Sleep Quality was assessed by taking the average of two items: How well do you feel this morning? And How enjoyable was your sleep last night? (0 = not at all, 4 = very).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waiting List Control | Sleep Quality | 1.77 0-4 scale of sleep quality | Standard Deviation 0.77 |
| Cognitive Behavioral Therapy | Sleep Quality | 2.18 0-4 scale of sleep quality | Standard Deviation 0.87 |
Secondary
Beliefs and Attitudes About Sleep
Time frame: 6 weeks
Secondary
Pre-Sleep Arousal
Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waiting List Control | Pre-Sleep Arousal | 25.46 PSA Scale | Standard Deviation 7.53 |
| Cognitive Behavioral Therapy | Pre-Sleep Arousal | 22.42 PSA Scale | Standard Deviation 7.97 |