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Metacognitive Therapy for Comorbid Insomnia

Primary Purpose

Secondary Insomnia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
meta-cognitive therapy
waiting list
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    meta-cognitive therapy

    waiting list

    Arm Description

    meta-cognitive therapy

    waiting list control

    Outcomes

    Primary Outcome Measures

    Scores on rating scales for sleep quality

    Secondary Outcome Measures

    Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing.

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    November 21, 2012
    Sponsor
    Norwegian University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00235365
    Brief Title
    Metacognitive Therapy for Comorbid Insomnia
    Official Title
    Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    problems recruiting patients
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect of meta-cognitive 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 receives meta-cognitive therapy, whereas the second group will be assigned to a waiting list control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    meta-cognitive therapy
    Arm Type
    Experimental
    Arm Description
    meta-cognitive therapy
    Arm Title
    waiting list
    Arm Type
    Active Comparator
    Arm Description
    waiting list control
    Intervention Type
    Behavioral
    Intervention Name(s)
    meta-cognitive therapy
    Intervention Description
    Meta-cognitive therapy
    Intervention Type
    Other
    Intervention Name(s)
    waiting list
    Intervention Description
    waiting list control
    Primary Outcome Measure Information:
    Title
    Scores on rating scales for sleep quality
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gunnar Morken, PhD MD
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Metacognitive Therapy for Comorbid Insomnia

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