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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

ClinicalTrials.gov processed this record on November 20, 2014