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

Primary Purpose

Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Treatment group
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Metacognitive therapy, Attention training technique

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Modum BadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Waitlist control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 28, 2022
Last Updated
May 30, 2022
Sponsor
University of Oslo
Collaborators
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT05402306
Brief Title
The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
Official Title
The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
January 28, 2023 (Anticipated)
Study Completion Date
January 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Modum Bad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Metacognitive therapy, Attention training technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment group
Intervention Description
Group metacognitive therapy, mainly with attention training technique over two weeks.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (Change)
Description
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
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
Social Phobia Inventory (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
CAS-1 (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
Inventory of Interpersonal Problems (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
Metacognition questionnaire 30 (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
The Short Warwick-Edinburgh Mental Well-Being scale (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Title
Work ability score (WAS) (Change)
Description
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.
Time Frame
Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Other Pre-specified Outcome Measures:
Title
Ecological Momentary Assessment-questions
Description
Single item questions capturing anxiety and depression symptoms, and different mechanisms of change.
Time Frame
4 times per day before, during and after treatment. The collection will go on for a total of six weeks.
Title
Mini-International Neuropsychiatric Interview
Description
Mini-International Neuropsychiatric Interview (M.I.N.I.; Sheehan et al., 1998) will be used for diagnostic evaluation of the participants.
Time Frame
Evaluation at baseline, two weeks after the intervention and follow up at 6 months.
Title
ADIS Severity Scale in Anxiety Disorders Interview Schedule IV (Brown, DiNardo & Barlow, 1996)
Description
We will use the ADIS Diagnostic severity Scale to evaluate the severity of the diagnoses.
Time Frame
Evaluation at baseline, two weeks after the intervention and follow up at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sverre Urnes Johnson, PhD
Phone
+4741633313
Email
s.u.johnson@psykologi.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre Urnes Johnson, PhD
Organizational Affiliation
University of Oslo & Modum Bad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Nordahl, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KariAnne Vrabel, PhD
Organizational Affiliation
Modum bad & University of Oslo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asle Hoffart, PhD
Organizational Affiliation
Modum Bad & University of Oslo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Therese R. Snuggerud, Masters
Organizational Affiliation
Modum Bad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Modum Bad
City
Vikersund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sverre Urnes Johnson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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