Predictive validity of the Work Ability Index and its individual items in the general population.
Andreas Lundin, Ola Leijon, Marjan Vaez...
https://pubmed.ncbi.nlm.nih.gov/28385066Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07579897
Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy
Led by Sorlandet Hospital HF · Updated on 2026-05-12
64
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two ways to deliver metacognitive therapy (MCT) for adults with generalized anxiety disorder (GAD), a long-lasting condition that causes excessive worry and reduces quality of life and work functioning. This randomized controlled trial aims to find out if group-based MCT is not less effective than individual MCT. The study's goal is to provide evidence that could help make therapy more accessible and efficient in real-world clinical care. Participants will receive either individual MCT with a trained clinician in weekly 45-minute sessions for 10 weeks or group-based MCT delivered by two clinicians in small groups of 4-6 participants meeting weekly for 90 minutes over 10 weeks. Both treatments follow established protocols focusing on reducing worry, changing unhelpful beliefs about worry, and improving attention control. During the study, participants will complete questionnaires and clinical assessments before, during, and after treatment, including follow-ups at 3 and 12 months. Researchers will collect data on anxiety symptoms, work participation, and social functioning using validated tools like the GAD-7. The study will also gather health information from official registries. The total participation includes treatment and long-term follow-up to assess outcomes and satisfaction.
CONDITIONS
Brief Title
Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults with a primary diagnosis of generalized anxiety disorder (GAD)
- GAD-7 score of 10 or higher at screening or baseline
- Experience problems with excessive worry
You will not qualify if you...
- Bipolar disorder
- Psychosis
- Ongoing substance abuse or dependence
- Intellectual disability based on medical history
- Eating disorder requiring medical attention
- Unwillingness to avoid anxiolytic drugs during treatment
- Current suicidal thoughts with a plan and intent
- Unstable antidepressant dose or recent dose change within 4 weeks
- Known cluster A or B personality disorder
- Serious medical conditions such as cancer or severe kidney failure
- Language difficulties requiring an interpreter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 10 weeks
Participants receive metacognitive therapy for generalized anxiety disorder either individually or in small groups. Treatment focuses on reducing worry, modifying maladaptive metacognitive beliefs, and promoting flexible attentional control.
Weekly visits for 10 weeks
Follow-up
Duration - Up to 12 months after treatment
Participants are followed up to assess treatment outcomes and maintain improvements after therapy ends.
Visits at 3 months and 12 months post-treatment
Trial Site Locations
Total: 2 locations
1
Sørlandet Hospital HF
Kristiansand, Agder, Norway
Actively Recruiting
2
Sørlandet Hospital HF
Kristiansand, Norway
Actively Recruiting
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Research Team
G
Gunvor Launes, MD Phd
A
Anna Sorte Grindvik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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D L Larsen, C C Attkisson, W A Hargreaves...
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https://pubmed.ncbi.nlm.nih.gov/14998733The Work and Social Adjustment Scale: a simple measure of impairment in functioning.
James C Mundt, Isaac M Marks, M Katherine Shear...
https://pubmed.ncbi.nlm.nih.gov/11983645Development and validation of the Penn State Worry Questionnaire.
T J Meyer, M L Miller, R L Metzger...
https://pubmed.ncbi.nlm.nih.gov/2076086A brief measure for assessing generalized anxiety disorder: the GAD-7.
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