The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Other: Treatment group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Ongoing drug abuse History of psychotic episodes Current suicidality Participants not able to adapt to an intensive group format

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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. | Other: Treatment group<br>* Group metacognitive therapy, mainly with attention training technique over two weeks.<br>|
| No Intervention: Waitlist control group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacognitive therapy, Attention training technique