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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00235365
Other study ID # S2005.2.gr
Secondary ID
Status Withdrawn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Status Withdrawn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


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
See also
  Status Clinical Trial Phase
Completed NCT00784875 - An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia Phase 2
Active, not recruiting NCT01804036 - Two Contrasting Interventions for Sleep Management Phase 2/Phase 3
Completed NCT00105872 - Behavioral Insomnia Therapy in Primary Care N/A