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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Online Cognitive behavioral treatment for insomnia

• Registration Number: NCT01955928
• Lead Sponsor: VU University of Amsterdam

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-21
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Cognitive behavioral treatment for insomnia	Online Cognitive behavioral treatment for insomnia	Online Cognitive behavioral treatment for insomnia

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	Change from baseline to post-test, 3-months, and 6-months follow-up	Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.

Trial Locations

Locations (1)

Department of Clinical Psychology; 🇳🇱 Amsterdam, Noord Holland, Netherlands