Back to resultsCognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Metacognitive therapy
Intolerance of uncertainty therapy
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
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
Sites / Locations
- Liljeholmen Primary Health Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Metacognitive therapy
Intolerance of uncertainty therapy
Arm Description
Outcomes
Primary Outcome Measures
Penn State Worry Questionnaire - measure of symptom change
A self-reported symptom measure of worry
Secondary Outcome Measures
Full Information
NCT ID
NCT03621371
First Posted
June 28, 2018
Last Updated
February 1, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT03621371
Brief Title
Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care
Official Title
Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metacognitive therapy
Arm Type
Experimental
Arm Title
Intolerance of uncertainty therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive therapy
Intervention Description
Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.
Intervention Type
Behavioral
Intervention Name(s)
Intolerance of uncertainty therapy
Intervention Description
Intolerance of uncertainty therapy is a form av cognitive-behavioral therapy which aims to reduce cognitive and behavioral avoidance of uncertain situations or cognitions which lead to worry in patients with generalized anxiety disorder.
Primary Outcome Measure Information:
Title
Penn State Worry Questionnaire - measure of symptom change
Description
A self-reported symptom measure of worry
Time Frame
Change from baseline symptoms at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Bohman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liljeholmen Primary Health Care Center
City
Stockholm
ZIP/Postal Code
11794
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care
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