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Online or Face-to-face Treatment for Insomnia?

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ClinicalTrials.gov Identifier: NCT01955850
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
Slaapmakend
Information provided by (Responsible Party):
Jaap Lancee, 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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Cognitive behavioral treatment for insomnia Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Internet-delivered CBT for insomnia
Online Cognitive behavioral treatment for insomnia
Behavioral: Cognitive behavioral treatment for insomnia
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

Experimental: Face-to-face CBT for insomnia
Face-to-face Cognitive behavioral treatment for insomnia
Behavioral: Cognitive behavioral treatment for insomnia
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

No Intervention: Waiting-list
Waiting-list



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955850


Locations
Netherlands
Department of Clinical Psychology
Amsterdam, Noord Holland, Netherlands, 1018XA
Sponsors and Collaborators
VU University of Amsterdam
Slaapmakend
Investigators
Principal Investigator: Jaap Lancee, PhD University of Amsterdam

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaap Lancee, PhD, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01955850     History of Changes
Other Study ID Numbers: UvA-2013-KP-3125
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders