Generalized Anxiety Disorder (GAD) Clinical Trials

Find Generalized Anxiety Disorder (GAD) Clinical Trials Near You

Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Sørlandet Hospital HF
RECRUITING
Kristiansand
Sørlandet Hospital HF
RECRUITING
Kristiansand
Contact Information
Primary
Gunvor Launes, MD Phd
Gunvor.Launes@sshf.no
+4747661428
Backup
Anna Sorte Grindvik, MD
Anna.Sorte.Grindvik@sshf.no
+4797771807
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2028-12
Participants
Target number of participants: 64
Treatments
Active_comparator: Individual Metacognitive Therapy (MCT)
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.
Experimental: Group Metacognitive Therapy (g-MCT)
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.
Related Therapeutic Areas
Sponsors
Leads: Sorlandet Hospital HF

This content was sourced from clinicaltrials.gov