Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

Study Overview
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Brief Summary
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The object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. Participants in the waiting-list condition receive treatment after the post-test. The interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. In this study we are interested in sleep-related worry and daily complaints measured with a diary. We expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.

Official Title
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Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Online Cognitive behavioral treatment for insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia disorder according to DSM-5 Sleep onset latency/wake after sleep onset > 30 minutes , three times or more a week Insomnia three months or longer Access to internet Exclusion Criteria: Earlier cognitive behavioral treatment for insomnia Start other psychological treatment in the last 6 months Doing shift work Pregnancy or breast feeding Schizophrenia or psychosis Suicidal plans Sleep apnea drugs or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Cognitive behavioral treatment for insomnia<br>Online Cognitive behavioral treatment for insomnia | Behavioral: Online Cognitive behavioral treatment for insomnia<br> <br> |
| No Intervention: Waiting-list<br>Waiting-list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime symptoms of sleep related worry measured with the APSQ | Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire. | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Daytime symptoms measured with diary consisting of the DASS-21 | The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21 | Change from baseline to post-test, 3-months, and 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression measured with the CES-D |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Anxiety measured with the HADS-A |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Sleep related safety behaviors measured with the SRBQ |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Sleep related arousal measured with the Pre-arousal sleep scale |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS) |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Sleep medication usage per day measured with the sleep diary |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time) | Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary. | Change from baseline to post-test, 3-months, and 6-months follow-up |