Online or Face-to-face Treatment for Insomnia?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Slaapmakend
Information provided by (Responsible Party):
Jaap Lancee, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01955850
First received: September 20, 2013
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Insomnia
Behavioral: Cognitive behavioral treatment for insomnia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.

  • Insomnia Severity Index [ Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety (HADS-A) [ Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Depression measured with the CES-D [ Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 VU University of Amsterdam
  More Information

Additional Information:
Publications:
Responsible Party: Jaap Lancee, PhD, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01955850     History of Changes
Other Study ID Numbers: UvA-2013-KP-3125
Study First Received: September 20, 2013
Last Updated: March 15, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on April 21, 2014