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Clinical Trials/NCT03621371
NCT03621371
Completed
Not Applicable

Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study

Karolinska Institutet1 site in 1 country64 target enrollmentJune 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Karolinska Institutet
Enrollment
64
Locations
1
Primary Endpoint
Penn State Worry Questionnaire - Measure of Symptom Change
Status
Completed
Last Updated
last year

Overview

Brief Summary

The feasibilty and preliminary comparative effectiveness of two methods of cognitive-behavioral therapy - metacognitive therapy and intolerance of uncertainty therapy - for primary care patients with generalized anxiety disorder is investigated in a pilot study using a randomized controlled design. Purpose of the study is to examine the feasibility of a full-scale randomized controlled trial. Research questions primarily concern recruitment, measurement, and adherence.

Registry
clinicaltrials.gov
Start Date
June 15, 2018
End Date
November 30, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benjamin Bohman

Dr

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Primary diagnosis of generalized anxiety disorder
  • Age 18 years or above
  • Being able to understand and speak Swedish without interpreter support

Exclusion Criteria

  • Psychosis, bipolar disorder, severe depressive symptoms, risk of suicid, substance use disorder, intellectual disability
  • Simultaneous psychological treatment
  • If pharmacological treatment, it needs to be stable prior to and during treatment

Outcomes

Primary Outcomes

Penn State Worry Questionnaire - Measure of Symptom Change

Time Frame: Change from baseline symptoms at 12 weeks

Penn State Worry Questionnaire, a self-reported symptom measure of worry. Scale ranges: 16-80 scores on a scale; higher values represent a worse outcome.

Study Sites (1)

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