Metacognitive Therapy for Comorbid Insomnia

This study is not yet open for participant recruitment.

Verified by Norwegian University of Science and Technology, February 2009

First Received: October 7, 2005 Last Updated: February 11, 2009 History of Changes

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00235365

Purpose

The purpose of this study is to determine the effect of metacognitive therapy for insomnia.

Condition	Intervention
Secondary Insomnia	Behavioral: Metacognitive therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Scores on rating scales for sleep quality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Metacognitive therapy

Detailed Description:

This study is a randomized controlled trial with 50 patients with a psychiatric disorder and insomnia. The patients will be randomized into two groups of 25 patients. The first group receive metacognitive therapy, whereas the second group will be assigned to a waiting list control.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Insomnia secondary to a primary psychiatric disorder

Exclusion Criteria:

substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235365

Contacts

Contact: Knut Langsrud, Psychiatrist	+4773864500	knut.langsrud@ntnu.no
Contact: Bjarne Hansen, Psychologist	+4773864604	bjarne.hansen@ntnu.no

Locations

Norway
Norwegian University of Science and Technology, Institute of Neuroscience
Trondheim, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Gunnar Morken, PhD MD

Norwegian University of Science and Technology

More Information

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Gunnar Morken, MD, PhD )
Study ID Numbers:	S2005.2.gr
Study First Received:	October 7, 2005
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00235365 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Neoplasm Metastasis

Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 06, 2009