ClinicalTrials.gg
CompletedNCT03621371Updated Jan 30, 2025Results posted

Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care

An interventional study of Metacognitive therapy and Intolerance of uncertainty therapy in Generalized Anxiety Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Generalized Anxiety Disorder
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In context

Generalized Anxiety Disorder

146 studies on the registry are indexed under Generalized Anxiety Disorder; 86 are open to participants now.

This study's enrollment of 64 is below the median of 100 across 120 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Metacognitive therapy

    Behavioral: Metacognitive therapy

  • Experimental
    Intolerance of uncertainty therapy

    Behavioral: Intolerance of uncertainty therapy

Interventions

  • BehavioralMetacognitive therapy

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

  • BehavioralIntolerance 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.

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What researchers measure

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.

    Time frame: Change from baseline symptoms at 12 weeks

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Results

Posted Jan 30, 2025

Participant flow

Participant flow — Overall Study
MilestoneMetacognitive TherapyIntolerance of Uncertainty Therapy
Started3133
Completed2532
Not completed61

Outcome measures

PrimaryPenn 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.

Time frame:
Change from baseline symptoms at 12 weeks
Reported as:
Mean · score on a scale
Penn State Worry Questionnaire - Measure of Symptom Change
score on a scaleMetacognitive TherapyIntolerance of Uncertainty Therapy
Penn State Worry Questionnaire - Measure of Symptom Change42.1 ± 7.555.8 ± 7.5
Statistical analysis
  • Metacognitive Therapy vs Intolerance of Uncertainty Therapy · Mixed Models Analysis · p = <0.05 · F-test: 9.88

Adverse events

Collected over Not assessed.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Metacognitive Therapy———
Intolerance of Uncertainty Therapy———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Metacognitive TherapyIntolerance of Uncertainty TherapyTotal
Mean35.7 ± 10.837.1 ± 11.636.4 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Metacognitive TherapyIntolerance of Uncertainty TherapyTotal
Female252752
Male6612
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Metacognitive TherapyIntolerance of Uncertainty TherapyTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Metacognitive TherapyIntolerance of Uncertainty TherapyTotal
Sweden313364
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Study locations

1 site
  • Liljeholmen Primary Health Care Center
    Stockholm, 11794, Sweden
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References and documents

Publications

  • 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. PubMed 37315099 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 4, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03621371
Collaborators
Region Stockholm
Responsible party
Benjamin Bohman (Dr, Karolinska Institutet) — Principal investigator
First posted
Aug 8, 2018
Start date
Jun 15, 2018
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Results posted
Jan 30, 2025
Last update
Jan 30, 2025

Study contacts

Benjamin Bohman, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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