Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621371
• Other study ID #: SLSO-2018/505-31/1
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Metacognitive therapy
Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.
• Intolerance of uncertainty therapy
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.

Locations

Country	Name	City	State
Sweden	Liljeholmen Primary Health Care Center	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn State Worry Questionnaire - measure of symptom change	A self-reported symptom measure of worry	Change from baseline symptoms at 12 weeks