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Completed

NCT Number: NCT01955850

Online or Face-to-face Treatment for Insomnia?

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Clinical Psychology

Amsterdam, North Holland, 1018XA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral treatment for insomnia

Behavioral

Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

Primary outcomes

  1. Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)

    Time frame: 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.

  2. Insomnia Severity Index

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

Secondary outcomes

  1. Anxiety (HADS-A)

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

  2. Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

  3. Sleep related arousal measured with the Pre-arousal sleep scale

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

  4. Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

  5. Sleep medication usage per day measured with the sleep diary

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

  6. Depression measured with the CES-D

    Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Collaborators

  • Slaapmakend

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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