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Metacognitive Therapy for Comorbid Insomnia

This study has been withdrawn prior to enrollment.
(problems recruiting patients)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00235365
First received: October 7, 2005
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.


Condition Intervention
Secondary Insomnia
 Behavioral: meta-cognitive therapy
Other: waiting list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

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 ]

Enrollment: 0
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: meta-cognitive therapy
meta-cognitive therapy
 Behavioral: meta-cognitive therapy
Meta-cognitive therapy
Active Comparator: waiting list
waiting list control
 Other: waiting list
waiting list control

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 receives meta-cognitive 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

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
ClinicalTrials.gov Identifier: NCT00235365     History of Changes
Other Study ID Numbers: S2005.2.gr
Study First Received: October 7, 2005
Last Updated: November 21, 2012
Health Authority: Norway: Norwegian Social Science Data Services

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 May 21, 2013