NCT00235365

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
3.8 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

October 7, 2005

Last Update Submit

November 21, 2012

Conditions

Secondary Insomnia

Outcome Measures

Primary Outcomes (1)

  • Scores on rating scales for sleep quality

    one year

Secondary Outcomes (1)

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

    one year

Study Arms (2)

meta-cognitive therapy

EXPERIMENTAL

meta-cognitive therapy

Behavioral: meta-cognitive therapy

waiting list

ACTIVE COMPARATOR

waiting list control

Other: waiting list

Interventions

meta-cognitive therapyBEHAVIORAL

Meta-cognitive therapy

meta-cognitive therapy
waiting listOTHER

waiting list control

waiting list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insomnia secondary to a primary psychiatric disorder

You may not qualify if:

  • substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Gunnar Morken, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 10, 2005

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 22, 2012

Record last verified: 2012-11