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Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

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ClinicalTrials.gov Identifier: NCT03621371
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Benjamin Bohman, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Metacognitive therapy Behavioral: Intolerance of uncertainty therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Metacognitive therapy 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.

Experimental: Intolerance of uncertainty therapy 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.




Primary Outcome Measures :
  1. Penn State Worry Questionnaire - measure of symptom change [ Time Frame: Change from baseline symptoms at 12 weeks ]
    A self-reported symptom measure of worry



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621371


Contacts
Contact: Benjamin Bohman, PhD 72-244 49 00 ext +46 benjamin.bohman@ki.se
Contact: Eva Toth-Pal, PhD 73-688 0552 ext +46 evatothpal@gmail.com

Locations
Sweden
Liljeholmen Primary Health Care Center Recruiting
Stockholm, Sweden, 11794
Contact: Sandra af Winklerfelt Hammarberg, MD    8-123 677 51 ext +46    sandra.afwinklerfelt-hammarberg@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Benjamin Bohman, PhD Karolinska Institutet

Responsible Party: Benjamin Bohman, Dr, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03621371     History of Changes
Other Study ID Numbers: SLSO-2018/505-31/1
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders