Metacognitive Therapy for Comorbid Insomnia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 7, 2005

Last Updated Date

February 11, 2009

Start Date ^†

August 2009

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00235365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Metacognitive Therapy for Comorbid Insomnia

Official Title ^†

Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.

Brief Summary

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^†

Secondary Insomnia

Intervention ^†

Behavioral: Metacognitive therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Estimated Completion Date

December 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

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

Location Countries ^†

Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00235365

Responsible Party

Gunnar Morken, MD, PhD, Norwegian University of Science and Technology

Secondary IDs ^††

Study Sponsor ^†

Norwegian University of Science and Technology

Collaborators ^††

Investigators ^†

Principal Investigator:

Gunnar Morken, PhD MD

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.