Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

NCT03621371 | Completed Results

• 1 other identifier: SLSO-2018/505-31/1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Penn State Worry Questionnaire - Measure of Symptom Change

  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.

  Change from baseline symptoms at 12 weeks

Study Arms (2)

Metacognitive therapy

EXPERIMENTAL

Behavioral: Metacognitive therapy

Intolerance of uncertainty therapy

EXPERIMENTAL

Behavioral: Intolerance of uncertainty therapy

Interventions

Metacognitive therapy BEHAVIORAL

Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.

Metacognitive therapy

Intolerance of uncertainty therapy 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.

Intolerance of uncertainty therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Liljeholmen Primary Health Care Center

Stockholm, 11794, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37315099 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Benjamin Bohman
• Organization: Karolinska Institutet

benjamin.bohman@ki.se

701713443

Study Officials

• Benjamin Bohman, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 8, 2018
• Study Start: June 15, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)