Generalized Anxiety DisorderNCT07579897
Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder
A study testing Individual Metacognitive Therapy and Group Metacognitive Therapy in people with Generalized Anxiety Disorder, run by Sorlandet Hospital HF at 2 sites in Norway.
Trial summary
Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Individual Metacognitive Therapy and Group Metacognitive 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
- 2 sitesNorway
- Study dates
- 27 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a primary diagnosis of generalized anxiety disorder (GAD). GAD-7 score ≥ 10 at screening/baseline. Participants must endorse that they experience problems with excessive worry
Who cannot join
- Bipolar disorder;
- Psychosis;
- Ongoing substance abuse/dependence;
- Intellectual disability based on previous medical history;
- Eating disorder in need of medical attention;
- Unwillingness to refrain from anxiolytic drugs during the treatment;
Show all 11Show fewer
- Current suicidal ideation with plan and intent;
- Taking an unstable dose of antidepressant, with recent dose-change within the last 4 weeks;
- Known cluster A or B personality disorder;
- Serious medical comorbidity (e.g.: cancer, severe renal failure)
- Language difficulties in need of an interpreter.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Sørlandet Hospital HF
Kristiansand, Agder
Anna Sorte Grindvik, MD, +4797771807, Anna.Sorte.Grindvik@sshf.no
- Recruiting
Sørlandet Hospital HF
Kristiansand
Anna Grindvik, MD, Anna.Sorte.Grindvik@sshf.no
About this study
Official title: Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy
Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients.
This randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries.
Read more
The main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care.
This will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.
Read the detailed description
Generalized anxiety disorder (GAD) is a chronic and disabling condition characterized by persistent and uncontrollable worry. Individuals with GAD frequently experience reduced quality of life, impaired daily functioning, and elevated use of health care services. Although effective psychological treatments exist, including metacognitive therapy (MCT), it remains unclear which treatment delivery format provides the best balance of clinical effectiveness and efficient use of resources.
MCT is an evidence-based treatment targeting the metacognitive processes that maintain excessive worry, including beliefs about the usefulness and uncontrollability of worrying and the cognitive-attentional syndrome (CAS), a pattern of worry, rumination, threat monitoring, and unhelpful coping behaviors. Individual MCT has demonstrated strong and consistent effects across several clinical trials, while group-based MCT (g-MCT) has shown promising preliminary results. However, the two formats have never been directly compared in a randomized trial conducted in routine clinical care. This represents a meaningful gap in the research literature and limits the ability of services to make informed decisions about how to organize treatment.
This study addresses this gap by conducting a randomized controlled trial (RCT) comparing individual MCT with group-based MCT for adults with GAD. An RCT design is chosen because it provides the highest level of evidence for causal inference about treatment effects. A non-inferiority framework is used to test whether group MCT is not meaningfully less effective than individual MCT. This design is appropriate when an alternative treatment may offer practical advantages-such as lower cost, greater accessibility, or more efficient resource use-while aiming to demonstrate that clinical outcomes remain comparable.
A total of 64 adults with a primary diagnosis of GAD will be enrolled and randomized to either individual MCT or group MCT. Both interventions follow established MCT protocols and are delivered by trained clinicians. Treatment focuses on reducing worry, modifying maladaptive metacognitive beliefs, and promoting flexible attentional control. Data collection includes validated self-report questionnaires, structured clinical assessments, and-with participant consent-information obtained from official national registers to assess work participation and sick leave pre and post treatment.
Evaluating group-based MCT is particularly important in the context of mental health services, where demand often exceeds available treatment resources. If group MCT is found to be non-inferior to individual MCT, it could make it possible to offer effective therapy to more patients within the same amount of therapist time. This has the potential to reduce waiting times, improve access to evidence-based treatment, and support more sustainable use of clinical resources.
The findings from this trial will contribute to the evidence base for MCT, clarify which treatment format is most appropriate for adults with GAD, and inform clinical guidelines and service organization. As the first randomized study to directly compare individual and group MCT in a real-world clinical setting, the results may have meaningful implications for both clinical practice and mental health policy.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Individual Metacognitive Therapy, Group Metacognitive Therapy
- Keywords
- Generalized Anxiety Disorder, GAD, Anxiety, Metacognitive Therapy, MCT, Group Metacognitive Therapy, Individual Metacognitive Therapy, Worry, Psychotherapy, RCT, Randomized Controlled Trial, Anxiety Treatment, Group Therapy, Adult Mental Health, Cognitive Attentional Syndrome, CAS
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Metacognitive TherapyBehavioural
Individual metacognitive therapy (MCT) is delivered by a trained clinician following the established protocol for generalized anxiety disorder. The treatment focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and promoting flexible attentional control. Participants receive 10 weekly individual sessions, each lasting approximately 45 minutes. The intervention targets excessive worry, unhelpful coping strategies, and beliefs about the uncontrollability and danger of worry.
Group Metacognitive TherapyBehavioural
Group Metacognitive Therapy (g-MCT) is delivered by two trained clinicians following the established group MCT protocol for generalized anxiety disorder. Treatment is provided in small groups of 4-6 participants and focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and improving attentional flexibility. Participants attend 10 weekly sessions, each lasting approximately 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Individual Metacognitive Therapy (MCT) | Active comparator | Participants receive individual metacognitive therapy delivered by a trained clinician according to the established MCT protocol for generalized anxiety disorder. Treatment is provided weekly for 10 weeks, each session lasting approximately 45 minutes. Receives: Behavioral: Individual Metacognitive Therapy |
| Group Metacognitive Therapy (g-MCT) | Experimental | Participants receive group-based metacognitive therapy delivered by two trained clinicians according to the established group MCT protocol for generalized anxiety disorder. Treatment is delivered in small groups of 4-6 participants meeting weekly for 10 weeks. Each session lasts approximately 90 minutes. Receives: Behavioral: Group Metacognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a validated 7-item self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater symptom severity. The primary outcome is change in GAD-7 score from pre-treatment (baseline, one week before treatment start) to post-treatment (one week after the last therapy session) and 3- month and 12- month follow up. The measure is widely used in clinical research and has demonstrated strong reliability, sensitivity to change, and clinical validity in GAD populations.
Measured: Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy session), 3-month follow-up, 12-month follow-u
Secondary outcomes (10)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item validated self-report measure of depressive symptom severity over the past two weeks. Scores range from 0-27, with higher scores indicating more severe depressive symptoms.
Measured: Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy sessio), 3-month follow-up, 12-month follow-up
Generalized Anxiety Disorder Scale-Revised (GADS-R)
The Generalized Anxiety Disorder Scale-Revised (GADS-R) is a self report questionaire assessing cognitive and behavioral symptoms of generalized anxiety disorder. The scale measures worry severety and maladaptive coping strategies on a 9-point Likert scale (0-8), while metacognitive beliefs about worry are rated on a 0-100 scale. Higher scores indicate greater symptom severity. Secondary outcomes include change in GADS-R score from pre-treatment (baseline) to post-treatment, as well as repeated GADS-R assessments administered during treatment (prior to each therapy session) and at 3-month and 12-month follow-up, to monitor clinical change over time.
Measured: Pre-treatment (baseline; one week before treatment start) , one day before each therapy session session, post-treatment (one week after last therapy session), 3-month follow-up, 12-month follow-up.
Work and Social Adjustment Scale (WSAS)
The Work and Social Adjustment Scale (WSAS) is a 5-item self-report questionnaire assessing functional impairment in work, home management, social leisure, private leisure, and close relationships. Scores range from 0-40, with higher scores indicating greater impairment. Secondary outcomes include change in WSAS score from pre-treatment (baseline) to post-treatment (one week after the last therapy session), as well as WSAS scores at 3-month and 12-month follow-up.
Measured: Pre-treatment (baseline; one week before treatment start) post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Metacognitions Questionnaire- 30 (MCQ-30)
The Metacognitions Questionnaire- 30 (MCQ-30) is a 30-item self-report measure assessing maladaptive metacognitive beliefs across five domains.Total scores range from 30 to 120, with higher scores indicating stronger dysfunctional metacognitive beliefs.
Measured: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure assessing satisfaction with treatment. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Measured: Post-treatment (one week after the last therapy session)
Working Alliance Inventory - Short, Client Version (WAI-C-S)
The Working Alliance Inventory - Short, Client Version (WAI-C-S) is a 12-item validated measure assessing the therapeutic alliance across goals, tasks, and bond. Total scores range from 12 to 84, with higher scores indicating a stronger therapeutic alliance.
Measured: Mid-treatment A (the day after therapy session 4), mid-treatment B (the day after therapy session 7), and post-treatment (one week after the last therapy session).
EQ-5D-5L
The EQ-5D-5L is a standardized self-report measure assessing health-related quality of life across five domains and includes a visual analogue scale (VAS). Higher scores indicate better perceived health.
Measured: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up.
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) is a 17-item measure evaluating fear, avoidance, and physiological symptoms of social anxiety. Scores range from 0-68, with higher scores indicating greater social anxiety.
Measured: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Work Ability Score (WAS)
The Work Ability Score (WAS) is a single-item measure rating current work ability compared to lifetime best on a scale of 0-10. Higher scores reflect better work ability.
Measured: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Clinical Severity Rating (CSR)
The Clinical Severity Rating (CSR) is a clinician-rated measure of overall diagnostic severity on a 0-8 scale, where higher scores indicate greater symptom severity and functional impairment. An external, independent clinician (physician or psychologist not involved in treatment or study procedures) conducts a brief structured assessment with each participant. The CSR evaluates both the primary diagnosis of generalized anxiety disorder (GAD) and any comorbid conditions, providing a standardized, observer-based measure of clinical severity and change over time.
Measured: Pre-treatment (baseline; one week before treatment start), post-treatment (1 week after the last therapy session), 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start27 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies 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
- Model description
- Participants are randomized to one of two parallel treatment arms: individual metacognitive therapy (MCT) or group-based MCT (g-MCT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gunvor Launes, MD, PhD, Principal investigator, Sørlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579897
- Sponsor's protocol ID
- 931881
- Other IDs
- PEIK 3797
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our ethical approval from the Regional Committees for Medical and Health Research Ethics (REK) does not allow us to share individual participant data (IPD). In accordance with the conditions set by REK, all data are stored securely and cannot be made available to external researchers. Data sharing is further restricted by Norwegian privacy legislation (GDPR) and institutional data protection requirements.
Publications
Brown TA, Barlow DH: Anxiety and related disorders interview schedule for DSM-5 (ADIS-5)-adult and lifetime version: Clinician manual, Oxford University Press; 2014
Lundin A, Leijon O, Vaez M, Hallgren M, Torgen M. Predictive validity of the Work Ability Index and its individual items in the general population. Scand J Public Health. 2017 Jun;45(4):350-356. doi: 10.1177/1403494817702759. Epub 2017 Apr 7.
PubMed 28385066Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
PubMed 10827888Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
PubMed 10245370Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5.
PubMed 14998733Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
PubMed 2076086Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy
- ClinicalTrials.gov ID
- NCT07579897
- Acronym / sponsor ID
- 931881
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, Anxiety, Metacognitive Therapy, MCT, Group Metacognitive Therapy, Individual Metacognitive Therapy, Worry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 May 2026 (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.
Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients.
This randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries.
The main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care.
This will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.
Detailed description
Generalized anxiety disorder (GAD) is a chronic and disabling condition characterized by persistent and uncontrollable worry. Individuals with GAD frequently experience reduced quality of life, impaired daily functioning, and elevated use of health care services. Although effective psychological treatments exist, including metacognitive therapy (MCT), it remains unclear which treatment delivery format provides the best balance of clinical effectiveness and efficient use of resources.
MCT is an evidence-based treatment targeting the metacognitive processes that maintain excessive worry, including beliefs about the usefulness and uncontrollability of worrying and the cognitive-attentional syndrome (CAS), a pattern of worry, rumination, threat monitoring, and unhelpful coping behaviors. Individual MCT has demonstrated strong and consistent effects across several clinical trials, while group-based MCT (g-MCT) has shown promising preliminary results. However, the two formats have never been directly compared in a randomized trial conducted in routine clinical care. This represents a meaningful gap in the research literature and limits the ability of services to make informed decisions about how to organize treatment.
This study addresses this gap by conducting a randomized controlled trial (RCT) comparing individual MCT with group-based MCT for adults with GAD. An RCT design is chosen because it provides the highest level of evidence for causal inference about treatment effects. A non-inferiority framework is used to test whether group MCT is not meaningfully less effective than individual MCT. This design is appropriate when an alternative treatment may offer practical advantages-such as lower cost, greater accessibility, or more efficient resource use-while aiming to demonstrate that clinical outcomes remain comparable.
A total of 64 adults with a primary diagnosis of GAD will be enrolled and randomized to either individual MCT or group MCT. Both interventions follow established MCT protocols and are delivered by trained clinicians. Treatment focuses on reducing worry, modifying maladaptive metacognitive beliefs, and promoting flexible attentional control. Data collection includes validated self-report questionnaires, structured clinical assessments, and-with participant consent-information obtained from official national registers to assess work participation and sick leave pre and post treatment.
Evaluating group-based MCT is particularly important in the context of mental health services, where demand often exceeds available treatment resources. If group MCT is found to be non-inferior to individual MCT, it could make it possible to offer effective therapy to more patients within the same amount of therapist time. This has the potential to reduce waiting times, improve access to evidence-based treatment, and support more sustainable use of clinical resources.
The findings from this trial will contribute to the evidence base for MCT, clarify which treatment format is most appropriate for adults with GAD, and inform clinical guidelines and service organization. As the first randomized study to directly compare individual and group MCT in a real-world clinical setting, the results may have meaningful implications for both clinical practice and mental health policy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two parallel treatment arms: individual metacognitive therapy (MCT) or group-based MCT (g-MCT).
| Arm | Type | Receives |
|---|---|---|
| Individual Metacognitive Therapy (MCT) | Active comparator | Behavioral: Individual Metacognitive TherapyParticipants receive individual metacognitive therapy delivered by a trained clinician according to the established MCT protocol for generalized anxiety disorder. Treatment is provided weekly for 10 weeks, each session lasting approximately 45 minutes. |
| Group Metacognitive Therapy (g-MCT) | Experimental | Behavioral: Group Metacognitive TherapyParticipants receive group-based metacognitive therapy delivered by two trained clinicians according to the established group MCT protocol for generalized anxiety disorder. Treatment is delivered in small groups of 4-6 participants meeting weekly for 10 weeks. Each session lasts approximately 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a primary diagnosis of generalized anxiety disorder (GAD). GAD-7 score ≥ 10 at screening/baseline. Participants must endorse that they experience problems with excessive worry
Key exclusion criteria (11 listed)
- Bipolar disorder;
- Psychosis;
- Ongoing substance abuse/dependence;
- Intellectual disability based on previous medical history;
- Eating disorder in need of medical attention;
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 |
|---|---|---|
| Individual Metacognitive TherapyIndividual metacognitive therapy (MCT) is delivered by a trained clinician following the established protocol for generalized anxiety disorder. The treatment focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and promoting flexible attentional control. Participants receive 10 weekly individual sessions, each lasting approximately 45 minutes. The intervention targets excessive worry, unhelpful coping strategies, and beliefs about the uncontrollability and danger of worry. | Behavioural | Individual Metacognitive Therapy (MCT) |
| Group Metacognitive TherapyGroup Metacognitive Therapy (g-MCT) is delivered by two trained clinicians following the established group MCT protocol for generalized anxiety disorder. Treatment is provided in small groups of 4-6 participants and focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and improving attentional flexibility. Participants attend 10 weekly sessions, each lasting approximately 90 minutes. | Behavioural | Group Metacognitive Therapy (g-MCT) |
Primary outcome
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy session), 3-month follow-up, 12-month follow-u
The Generalized Anxiety Disorder-7 (GAD-7) is a validated 7-item self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater symptom severity. The primary outcome is change in GAD-7 score from pre-treatment (baseline, one week before treatment start) to post-treatment (one week after the last therapy session) and 3- month and 12- month follow up. The measure is widely used in clinical research and has demonstrated strong reliability, sensitivity to change, and clinical validity in GAD populations.
10 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy sessio), 3-month follow-up, 12-month follow-up
Generalized Anxiety Disorder Scale-Revised (GADS-R)
Time frame: Pre-treatment (baseline; one week before treatment start) , one day before each therapy session session, post-treatment (one week after last therapy session), 3-month follow-up, 12-month follow-up.
Work and Social Adjustment Scale (WSAS)
Time frame: Pre-treatment (baseline; one week before treatment start) post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Metacognitions Questionnaire- 30 (MCQ-30)
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment (one week after the last therapy session)
Working Alliance Inventory - Short, Client Version (WAI-C-S)
Time frame: Mid-treatment A (the day after therapy session 4), mid-treatment B (the day after therapy session 7), and post-treatment (one week after the last therapy session).
EQ-5D-5L
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up.
Social Phobia Inventory (SPIN)
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Work Ability Score (WAS)
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Clinical Severity Rating (CSR)
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (1 week after the last therapy session), 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- BackgroundBrown TA, Barlow DH: Anxiety and related disorders interview schedule for DSM-5 (ADIS-5)-adult and lifetime version: Clinician manual, Oxford University Press; 2014
- Background: PubMed 28385066Lundin A, Leijon O, Vaez M, Hallgren M, Torgen M. Predictive validity of the Work Ability Index and its individual items in the general population. Scand J Public Health. 2017 Jun;45(4):350-356. doi: 10.1177/1403494817702759. Epub 2017 Apr 7.
- Background: PubMed 10827888Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 10245370Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- Background: PubMed 14998733Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5.
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- Individual participant dataSharing planned: No. Our ethical approval from the Regional Committees for Medical and Health Research Ethics (REK) does not allow us to share individual participant data (IPD). In accordance with the conditions set by REK, all data are stored securely and cannot be made available to external researchers. Data sharing is further restricted by Norwegian privacy legislation (GDPR) and institutional data protection requirements.
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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.
Gunvor Launes, MD, PhD principal investigator
Sørlandet Hospital HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Metacognitive Therapy and Group Metacognitive Therapy in people with Generalized Anxiety Disorder, run by Sorlandet Hospital HF at 2 sites 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunvor Launes, MD Phd (+4747661428, Gunvor.Launes@sshf.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 (GAD-7) (time frame: Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy session), 3-month follow-up, 12-month follow-u). 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 NCT07579897, which also lists 10 linked publications.
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 12 May 2026.