Metacognitive Therapy for Comorbid Insomnia

Secondary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00235365
• Other study ID #: S2005.2.gr
• Status: Withdrawn
• Phase: N/A
• First received: October 7, 2005
• Last updated: November 21, 2012
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Secondary Insomnia

Intervention

Behavioral:
• meta-cognitive therapy
Meta-cognitive therapy

Other:
• waiting list
waiting list control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on rating scales for sleep quality		one year	No
Secondary	Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing.		one year	No