Online or Face-to-face Treatment for Insomnia?

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 face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face 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 fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.

Official Title
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Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: 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 Possibility to travel to one of the treatment sites Exclusion Criteria: Earlier cognitive behavioral treatment for insomnia Start other psychological treatment in the last 6 months Doing shift work Major depression disorder 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: Internet-delivered CBT for insomnia<br>Online Cognitive behavioral treatment for insomnia | Behavioral: Cognitive behavioral treatment for insomnia<br>* Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.<br>|
| Experimental: Face-to-face CBT for insomnia<br>Face-to-face Cognitive behavioral treatment for insomnia | Behavioral: Cognitive behavioral treatment for insomnia<br>* Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.<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 |
| --- | --- | --- |
| Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time) | For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary. | Change from baseline to post-test, 3-months, and 6-months follow-up | 
| Insomnia Severity Index |  | Change from baseline to post-test, 3-months, and 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (HADS-A) |  | 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 | 
| 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 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 | 
| Depression measured with the CES-D |  | Change from baseline to post-test, 3-months, and 6-months follow-up |