Online or Face-to-face Treatment for Insomnia?

VU University of Amsterdam

Status and phase: Completed; Phase 3

Conditions: Insomnia

Treatments: Behavioral: Cognitive behavioral treatment for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT01955850

UvA-2013-KP-3125

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Internet-delivered CBT for insomnia

Experimental group

Description:

Online Cognitive behavioral treatment for insomnia

Treatment:

Behavioral: Cognitive behavioral treatment for insomnia

Face-to-face CBT for insomnia

Experimental group

Description:

Face-to-face Cognitive behavioral treatment for insomnia

Treatment:

Behavioral: Cognitive behavioral treatment for insomnia

Waiting-list

No Intervention group

Description:

Waiting-list