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Completed

NCT Number: NCT01955928

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

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.

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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

Not applicable

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

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

Treatment and study plan

Online Cognitive behavioral treatment for insomnia

Behavioral

Primary outcomes

  1. Daytime symptoms of sleep related worry measured with the APSQ

    Time frame: 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.

  2. Daytime symptoms measured with diary consisting of the DASS-21

    Time frame: 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 outcomes

  1. Depression measured with the CES-D

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

  2. Anxiety measured with the HADS-A

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

  3. Sleep related safety behaviors measured with the SRBQ

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

  4. 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

  5. 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

  6. Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire

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

  7. 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

  8. 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

  9. 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

    Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Oct 15, 2018

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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