Generalized Anxiety DisorderNCT03621371
Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care
A study testing Metacognitive therapy and Intolerance of uncertainty therapy in people with Generalized Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Metacognitive therapy and Intolerance of uncertainty therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of generalized anxiety disorder
- Age 18 years or above
- Being able to understand and speak Swedish without interpreter support
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study
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
- Being tested
- Metacognitive therapy, Intolerance of uncertainty therapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive therapyBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive therapy | Experimental | Not described Receives: Behavioral: Metacognitive therapy |
| Intolerance of uncertainty therapy | Experimental | Not described Receives: Behavioral: Intolerance of uncertainty therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline symptoms at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Jun 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Benjamin Bohman, Karolinska Institutet
- Investigators
- Benjamin Bohman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621371
- Sponsor's protocol ID
- SLSO-2018/505-31/1
- Status last verified
- Jan 2025
- First submitted
- 28 Jun 2018
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03621371
- Acronym / sponsor ID
- SLSO-2018/505-31/1
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive therapy | Experimental | Behavioral: Metacognitive therapy |
| Intolerance of uncertainty therapy | Experimental | Behavioral: Intolerance of uncertainty therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of generalized anxiety disorder
- Age 18 years or above
- Being able to understand and speak Swedish without interpreter support
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive therapyMetacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder. | Behavioural | Metacognitive therapy |
| Intolerance of uncertainty therapyIntolerance 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. | Behavioural | Intolerance of uncertainty therapy |
Primary outcome
Penn State Worry Questionnaire - Measure of Symptom Change
Time frame: Change from baseline symptoms at 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37315099Af 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Bohman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive therapy and Intolerance of uncertainty therapy in people with Generalized Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire - Measure of Symptom Change (time frame: Change from baseline symptoms at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.