Online or Face-to-face Treatment for Insomnia?

Phase 3

Completed

• Conditions: Insomnia

• Registration Number: NCT01955850
• Lead Sponsor: VU University of Amsterdam

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-20
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2014-04
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Insomnia Severity Index	Change from baseline to post-test, 3-months, and 6-months follow-up

Secondary Outcome Measures

Name	Time	Method
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
Anxiety (HADS-A)	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
Sleep related arousal measured with the Pre-arousal sleep scale	Change from baseline to post-test, 3-months, and 6-months follow-up

Trial Locations

Locations (1)

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