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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402306
• Other study ID #: REK269896
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: January 28, 2023

Study information

• Verified date: May 2022
• Source: University of Oslo
• Contact: Sverre Urnes Johnson, PhD
• Phone: +4741633313
• Email: s.u.johnson[@]psykologi.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Other:
• Treatment group
Group metacognitive therapy, mainly with attention training technique over two weeks.

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ecological Momentary Assessment-questions	Single item questions capturing anxiety and depression symptoms, and different mechanisms of change.	4 times per day before, during and after treatment. The collection will go on for a total of six weeks.
Other	Mini-International Neuropsychiatric Interview	Mini-International Neuropsychiatric Interview (M.I.N.I.; Sheehan et al., 1998) will be used for diagnostic evaluation of the participants.	Evaluation at baseline, two weeks after the intervention and follow up at 6 months.
Other	ADIS Severity Scale in Anxiety Disorders Interview Schedule IV (Brown, DiNardo & Barlow, 1996)	We will use the ADIS Diagnostic severity Scale to evaluate the severity of the diagnoses.	Evaluation at baseline, two weeks after the intervention and follow up at 6 months.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.