Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

NCT07579897 | Recruiting

• 2 other identifiers: 931881PEIK 3797
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Generalized Anxiety Disorder

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  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)

  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)

  Post-treatment (one week after the last therapy session)

Study Arms (2)

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.

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.

Behavioral: Group Metacognitive Therapy

Interventions

Individual Metacognitive Therapy BEHAVIORAL

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.

Individual Metacognitive Therapy (MCT)

Group Metacognitive Therapy BEHAVIORAL

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.

Group Metacognitive Therapy (g-MCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (2)

Sørlandet Hospital HF

Kristiansand, Agder, Norway

RECRUITING

Sørlandet Hospital HF

Kristiansand, Norway

RECRUITING

Related Publications (10)

• 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

  BACKGROUND

• 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.

  PMID: 28385066 BACKGROUND

• Connor 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.

  PMID: 10827888 BACKGROUND

• Herdman 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.

  PMID: 21479777 BACKGROUND

• Larsen 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.

  PMID: 10245370 BACKGROUND

• Wells 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.

  PMID: 14998733 BACKGROUND

• Mundt 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.

  PMID: 11983645 BACKGROUND

• Meyer 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.

  PMID: 2076086 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Gunvor Launes, MD, PhD

  Sørlandet Hospital HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunvor Launes, MD Phd

CONTACT

+4747661428; Gunvor.Launes@sshf.no

Anna Sorte Grindvik, MD

CONTACT

+4797771807; Anna.Sorte.Grindvik@sshf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The raters conducting the CSR rating are trained independent clinicans, and are masked regarding treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two parallel treatment arms: individual metacognitive therapy (MCT) or group-based MCT (g-MCT).

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 12, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)