Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

NCT ID: NCT03621371

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2019-11-30

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metacognitive therapy

Group Type: EXPERIMENTAL

Metacognitive therapy

Intervention Type: BEHAVIORAL

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

Group Type: EXPERIMENTAL

Intolerance of uncertainty therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Metacognitive therapy

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

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Bohman

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Bohman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Liljeholmen Primary Health Care Center

Stockholm, , Sweden

Countries

Sweden

References

Af Winklerfelt Hammarberg S, Toth-Pal E, Jansson-Frojmark M, Lundgren T, Westman J, Bohman B. Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial. PLoS One. 2023 Jun 14;18(6):e0287171. doi: 10.1371/journal.pone.0287171. eCollection 2023.

Reference Type: DERIVED

PMID: 37315099 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SLSO-2018/505-31/1

Identifier Type: -

Identifier Source: org_study_id