Anxiety DisordersNCT05402306
The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
A study testing Treatment group in people with Anxiety Disorders, run by University of Oslo at 1 site in Norway.
Trial summary
Long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 28 Feb 2022to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between 18 and 30 years
- Meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia
- Provide written consent to partake in the study
Who cannot join
- Ongoing drug abuse
- History of psychotic episodes
- Current suicidality
- Participants not able to adapt to an intensive group format
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Modum Bad
Vikersund
Sverre Urnes Johnson, PhD
About this study
Long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. To overcome these challenges intensive treatments are currently emerging and several research studies have shown significant and lasting results of diagnosis-specific intensive treatments. A transdiagnostic treatment in a group setting can contribute to a more efficient course of treatment for patients.
Research suggests that Metacognitive Therapy (MCT) is an effective treatment for anxiety disorders. However, MCT has not previously been used on inpatients over a two-week period. To make the treatment tangible for patients and easy to administer for therapists over a short time, attention training technique (ATT) will mainly be used as a changing technique.
The main aim of the study is to explore the feasibility and efficacy of intensive and short-term MCT for anxiety disorders in a group setting.
Read the detailed description
Design: The study will use randomized control trial with a waitlist control. Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after the two-week waiting period.
Inclusion criteria: Adults ranging from 18 to 30 years of age meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia will be included in the study. Further the participants must be able to communicate in Norwegian and provide written consent.
Exclusion criteria: Exclusion criteria will be ongoing drug abuse, history of psychotic episodes, current suicidality, or participants not able to adapt to an intensive group format.
- Conditions
- Anxiety Disorders
- Being tested
- Treatment group
- Keywords
- Metacognitive therapy, Attention training technique
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupOther
Group metacognitive therapy, mainly with attention training technique over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | A two-week intensive group treatment with MCT mainly focusing on attention training. The participants will be allocated into treatment in groups of six. Group sessions will be conducted two times a day for approximately 60 minutes. Receives: Other: Treatment group |
| Waitlist control group | No intervention | Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after four-week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7 (Change)
The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) will be used to measure anxiety symptoms. GAD-7 is a seven-item, self-report measure which assess the severity of anxiety symptoms within the last two weeks. The items are scored on a four-point Likert scale (0-3), with the scores ranging from minimum 0 to maximum 21. Higher scores means worse outcome.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Secondary outcomes (7)
Patient Health Questionnaire-9 (Change)
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) will be used to measure symptoms of depression. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Social Phobia Inventory (Change)
Social Phobia Inventory (SPIN; Connor et al., 2000) will be used to measure symptoms of social phobia. SPIN is a 17-item, self-report measure which assess social phobia symptoms during the last weeks. Items is rated from 0 to 4, from "not at all", "a little bit", "somewhat", "very much" to "extremely". The score ranges from 0 to 68. Higher scores indicate greater social anxiety severity. A cut-off score of 19 assumes to indicate a clinical social phobia.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
CAS-1 (Change)
CAS-1 (Wells, 2009) is a 16-item self-report measure which assess metacognitive strategies and metacognitive beliefs within the last week.The first two items examine time used on worry/rumination and threat monitoring rated on an eight-point scale from "no time" to "all the time". The next six items assess unhelpful coping behaviours on the same likert-scale. The last eight items investigate metacognitive beliefs which is rated from 0 to 100. Higher scores means more time spent on CAS and higher belief in metacognitions.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Inventory of Interpersonal Problems (Change)
Inventory of Interpersonal Problems (IIP-32; Horowitz et al., 2000) is a 32-item self-report questionnaire which measure interpersonal functioning in total and on eight different subscales. The items are rated from 0 "not at all" to 4 "extremely". High scores for the total score and the subscales indicate an increased level of interpersonal problems.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Metacognition questionnaire 30 (Change)
The Metacognition questionnaire (MCQ-30; Wells \& Cartwright-Hatton, 2004) will be used to measure metacognitive beliefs. MCQ-30 is a 30-item self-report measuring general belief in different metacognitions on a scale from 1 to 4, and the responses are "do not agree", "agree slightly", "agree moderately", and "agree very much". The items are divided in five subscales; cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability and danger, and need to control thoughts. The scores for each subscale range from 6 to 24. Summing each subscale gives an overall total score that ranges from 30 to 120, with higher scores indicating higher beliefs in metacognitions.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
The Short Warwick-Edinburgh Mental Well-Being scale (Change)
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS; Stewart-Brown et al., 2009) is a measure of mental well-being. SWEMWBS is a seven-item self-report related to positive aspects of subjective well-being and psychological functioning over the previous two weeks. Items is rated from 1 "none of the time" to 5 "all of the time". Scores range from 7 to 35 and a higher score indicates a higher level of mental well-being.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Work ability score (WAS) (Change)
The single-item Work Ability Score (WAS) will be used to measure work ability. The WAS concerns the first item of the 7-item Work Ability Index (WAI), "Current work ability compared with the lifetime best" (Ilmarines, 2007). The item is rated from 0 "completely unable to work" to 10 "work ability at its best". Higher score indicate greater work ability.
Measured: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start28 Feb 2022
- Primary completion28 Jan 2023 (estimated)
- Study completion28 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Sverre Urnes Johnson, PhD, Principal investigator, University of Oslo & Modum BadHenrik Nordahl, PhD, Principal investigator, Norwegian University of Science and TechnologyKariAnne Vrabel, PhD, Principal investigator, Modum bad & University of OsloAsle Hoffart, PhD, Principal investigator, Modum Bad & University of OsloTherese R. Snuggerud, Masters, Principal investigator, Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402306
- Sponsor's protocol ID
- REK269896
- Status last verified
- May 2022
- First submitted
- 28 Feb 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snuggerud TR, Nordahl H, Vrabel K, Hoffart A, Johnson SU. The feasibility and preliminary outcomes of a two-week attention training technique intervention for young adults with mixed anxiety disorders. Cogn Behav Ther. 2026 May;55(3):372-390. doi: 10.1080/16506073.2025.2509168. Epub 2025 May 27.
PubMed 40424353
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
- ClinicalTrials.gov ID
- NCT05402306
- Acronym / sponsor ID
- REK269896
- Conditions
- Anxiety Disorders
- Keywords
- Metacognitive therapy, Attention training technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Jan 2023 (estimated)
- Study completion
- 28 Jan 2023 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. To overcome these challenges intensive treatments are currently emerging and several research studies have shown significant and lasting results of diagnosis-specific intensive treatments. A transdiagnostic treatment in a group setting can contribute to a more efficient course of treatment for patients.
Research suggests that Metacognitive Therapy (MCT) is an effective treatment for anxiety disorders. However, MCT has not previously been used on inpatients over a two-week period. To make the treatment tangible for patients and easy to administer for therapists over a short time, attention training technique (ATT) will mainly be used as a changing technique.
The main aim of the study is to explore the feasibility and efficacy of intensive and short-term MCT for anxiety disorders in a group setting.
Detailed description
Design: The study will use randomized control trial with a waitlist control. Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after the two-week waiting period.
Inclusion criteria: Adults ranging from 18 to 30 years of age meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia will be included in the study. Further the participants must be able to communicate in Norwegian and provide written consent.
Exclusion criteria: Exclusion criteria will be ongoing drug abuse, history of psychotic episodes, current suicidality, or participants not able to adapt to an intensive group format.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Treatment groupA two-week intensive group treatment with MCT mainly focusing on attention training. The participants will be allocated into treatment in groups of six. Group sessions will be conducted two times a day for approximately 60 minutes. |
| Waitlist control group | No intervention | –Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after four-week waiting period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults between 18 and 30 years
- Meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia
- Provide written consent to partake in the study
Key exclusion criteria (4 listed)
- Ongoing drug abuse
- History of psychotic episodes
- Current suicidality
- Participants not able to adapt to an intensive group format
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 |
|---|---|---|
| Treatment groupGroup metacognitive therapy, mainly with attention training technique over two weeks. | Other | Treatment group |
Primary outcome
Generalized Anxiety Disorder-7 (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) will be used to measure anxiety symptoms. GAD-7 is a seven-item, self-report measure which assess the severity of anxiety symptoms within the last two weeks. The items are scored on a four-point Likert scale (0-3), with the scores ranging from minimum 0 to maximum 21. Higher scores means worse outcome.
7 secondary outcomes
Patient Health Questionnaire-9 (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Social Phobia Inventory (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
CAS-1 (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Inventory of Interpersonal Problems (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Metacognition questionnaire 30 (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
The Short Warwick-Edinburgh Mental Well-Being scale (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Work ability score (WAS) (Change)
Time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 40424353Snuggerud TR, Nordahl H, Vrabel K, Hoffart A, Johnson SU. The feasibility and preliminary outcomes of a two-week attention training technique intervention for young adults with mixed anxiety disorders. Cogn Behav Ther. 2026 May;55(3):372-390. doi: 10.1080/16506073.2025.2509168. Epub 2025 May 27.
- 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.
Sverre Urnes Johnson, PhD principal investigator
University of Oslo & Modum Bad
Henrik Nordahl, PhD principal investigator
Norwegian University of Science and Technology
KariAnne Vrabel, PhD principal investigator
Modum bad & University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group in people with Anxiety Disorders, run by University of Oslo at 1 site in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sverre Urnes Johnson, PhD (+4741633313, s.u.johnson@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (Change) (time frame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.). 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 NCT05402306, 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 2 Jun 2022.