Metacognitive Therapy for Comorbid Insomnia
This study has been withdrawn prior to enrollment.
(problems recruiting patients)
Sponsor:
Norwegian University of Science and Technology
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 7, 2005 | ||||
| Last Updated Date | November 21, 2012 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Scores on rating scales for sleep quality [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Scores on rating scales for sleep quality | ||||
| Change History | Complete list of historical versions of study NCT00235365 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ICMJE |
Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Metacognitive Therapy for Comorbid Insomnia | ||||
| Official Title ICMJE | Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia. | ||||
| Brief Summary | The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Secondary Insomnia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00235365 | ||||
| Other Study ID Numbers ICMJE | S2005.2.gr | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Norwegian University of Science and Technology | ||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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