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The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata

Primary Purpose

Alopecia Areata, Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • AA is the main presenting physical health problem
  • Participant self-identifies as experiencing social anxiety
  • Sufficient English to participate in group sessions and discussion.
  • Aged 16 and over

Exclusion Criteria:

  • Primary psychiatric diagnosis affecting skin (e.g., trichotillomania)
  • Hair loss as a result of medical intervention or surgery (e.g., chemotherapy)
  • The skin condition is secondary to other physical health problems (e.g., arthritis, cancer, chronic pain)
  • Patient does not report any social distress as a result of their AA
  • Currently undergoing other psychological therapy

Sites / Locations

  • The University of Sheffield
  • Royal Hallamshire Hospital (Sheffield Teaching Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-based cognitive therapy

Arm Description

There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in an MBCT intervention whilst the same variables are measured. Following the intervention,there will be a 4-week follow-up period, and MBCT groups will not run during this time.

Outcomes

Primary Outcome Measures

Change in social anxiety (idiosyncratic measure)
The primary outcome measures for the proposed study are idiosyncratic measures of social anxiety which will be assessed daily by text message. Participants will be asked to identify one social anxiety-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale

Secondary Outcome Measures

Social Anxiety
The Brief Fear of Negative Evaluation straight forward items (BFNE-S: Carleton, Collimore, McCabe, & Antony, 2011) will be used to assess social anxiety. The measure consists of 8 questions rated on a 5-point Likert scale (from "not at all characteristic of me" to "entirely characteristic of me").
Mindfulness
The Five Factor Mindfulness Questionnaire-15 (FFMQ-15; Baer, Carmody, & Hunsinger, 2012) will be used to measure mindfulness. Items are rated on a five-point Likert scale (from "never or very rarely true" to "very often or always true").
Mindfulness
The Five Factor Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer & Toney, 2006) will also be used to measure mindfulness. Items are rated on a five-point Likert scale (from "never or very rarely true" to "very often or always true").
Depression
The 9-item self-report Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999) will be used to measure symptoms of depression. Items are rated on a four-point Likert scale (from "not at all" to "nearly every day").
Anxiety
The Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kronke, Williams, & Lowe, 2006) is a 7 item self-report scale to measure generalized anxiety symptoms. Items are rated on a four-point Likert scale (from "not at all" to "nearly every day").
Quality of life (dermatology-related)
The Dermatology Quality of Life Index (DLQI: Findlay & Khan, 1994) consists of 10 questions concerning the impact of the skin condition over the last week. Questions relate to symptoms and feelings, daily activity, leisure, work/school, personal relationships and side effects of treatment. Items are rated on a 4-point Likert scale (from "not at all" to "very much").
Service use
The Client Service and Receipt Inventory (CSRI; Beecham & Knapp, 2001) is a 6 question measure of client service utilization. More specifically, the CSRI measures how often participants have met with a healthcare professional, visited A & E, been an inpatient, used an ambulance, received a diagnostic test, and days spent away from work due to ill health.
Work and social adjustment
The Work and Social Adjustment Scale (WSAS; Mundt & Marks, 2002) is a 5-item measure of the impact of mental health issues on an individual's social life and ability to work.

Full Information

First Posted
March 4, 2019
Last Updated
September 30, 2019
Sponsor
University of Sheffield
Collaborators
Alopecia UK
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1. Study Identification

Unique Protocol Identification Number
NCT03873155
Brief Title
The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata
Official Title
The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata: A Single Group Case Series.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
Collaborators
Alopecia UK

4. Oversight

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

5. Study Description

Brief Summary
This study investigates the impact of mindfulness based cognitive therapy (MBCT) on social anxiety in adults with alopecia areata. A single-group case-series design will be adopted.
Detailed Description
Alopecia areata (AA) is an immunological disorder which is characterised by round/oval patches of non-scarring hair loss. People living with AA are at higher risk of developing depression, anxiety and social phobia than the general population (Koo et al., 1994; Ruiz-Doblado, Carrizosa, & García-Hernández, 2003). Interventions that aim to reduce engagement in negative appearance related thoughts, and attentional bias towards negative self-referential information may be helpful for this population. Mindfulness-based cognitive therapy (MBCT) offers one potential method of reducing social anxiety in individuals with AA. MBC is a structured eight-week programme that has been recommended by the National Institute of Clinical Excellence as an effective intervention to reduce the risk of relapse in depression since 2009. The main aim of the current study is to investigate whether an MBCT course can reduce social anxiety in individuals with AA. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Semi-structured interviews will be carried out at the end of the study to investigate participants experiences of the intervention. The investigators predict that MBCT will reduce social anxiety in individuals with AA. More specifically, the hypothesis are: (i) participants will experience an increase in mindfulness during the intervention period, relative to the baseline phase and this will be maintained at follow-up (ii) increases in mindfulness will be associated with decreases in social anxiety, anxiety and depression, and increases in dermatology quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata, Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-group case-series design will be adopted, whereby one group of participants will complete daily and weekly measures over the course of 1) a 4-week randomised multi-baseline period; 2) a 9-week intervention period (one introductory week added on to usual structure); 3) a 4-week follow up-period. Variables collected during the intervention and follow-up period will be compared with those from the baseline period.
Masking
None (Open Label)
Masking Description
No party will be masked in this study. There is only one arm and participants will act as their own controls
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based cognitive therapy
Arm Type
Experimental
Arm Description
There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in an MBCT intervention whilst the same variables are measured. Following the intervention,there will be a 4-week follow-up period, and MBCT groups will not run during this time.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Description
Mindfulness based cognitive group therapy (MBCT) is a structured eight-week programme (although an extra introductory week will be added in the current study) that combines mindfulness-based exercises with cognitive therapy.
Primary Outcome Measure Information:
Title
Change in social anxiety (idiosyncratic measure)
Description
The primary outcome measures for the proposed study are idiosyncratic measures of social anxiety which will be assessed daily by text message. Participants will be asked to identify one social anxiety-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale
Time Frame
Daily for 20 weeks (baseline-intervention-follow-up)
Secondary Outcome Measure Information:
Title
Social Anxiety
Description
The Brief Fear of Negative Evaluation straight forward items (BFNE-S: Carleton, Collimore, McCabe, & Antony, 2011) will be used to assess social anxiety. The measure consists of 8 questions rated on a 5-point Likert scale (from "not at all characteristic of me" to "entirely characteristic of me").
Time Frame
Weekly for 21 weeks (baseline-intervention-follow-up)
Title
Mindfulness
Description
The Five Factor Mindfulness Questionnaire-15 (FFMQ-15; Baer, Carmody, & Hunsinger, 2012) will be used to measure mindfulness. Items are rated on a five-point Likert scale (from "never or very rarely true" to "very often or always true").
Time Frame
Weekly for 21 weeks (baseline-intervention-follow-up)
Title
Mindfulness
Description
The Five Factor Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer & Toney, 2006) will also be used to measure mindfulness. Items are rated on a five-point Likert scale (from "never or very rarely true" to "very often or always true").
Time Frame
4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
Title
Depression
Description
The 9-item self-report Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999) will be used to measure symptoms of depression. Items are rated on a four-point Likert scale (from "not at all" to "nearly every day").
Time Frame
4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
Title
Anxiety
Description
The Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kronke, Williams, & Lowe, 2006) is a 7 item self-report scale to measure generalized anxiety symptoms. Items are rated on a four-point Likert scale (from "not at all" to "nearly every day").
Time Frame
4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
Title
Quality of life (dermatology-related)
Description
The Dermatology Quality of Life Index (DLQI: Findlay & Khan, 1994) consists of 10 questions concerning the impact of the skin condition over the last week. Questions relate to symptoms and feelings, daily activity, leisure, work/school, personal relationships and side effects of treatment. Items are rated on a 4-point Likert scale (from "not at all" to "very much").
Time Frame
4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
Title
Service use
Description
The Client Service and Receipt Inventory (CSRI; Beecham & Knapp, 2001) is a 6 question measure of client service utilization. More specifically, the CSRI measures how often participants have met with a healthcare professional, visited A & E, been an inpatient, used an ambulance, received a diagnostic test, and days spent away from work due to ill health.
Time Frame
3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
Title
Work and social adjustment
Description
The Work and Social Adjustment Scale (WSAS; Mundt & Marks, 2002) is a 5-item measure of the impact of mental health issues on an individual's social life and ability to work.
Time Frame
3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AA is the main presenting physical health problem Participant self-identifies as experiencing social anxiety Sufficient English to participate in group sessions and discussion. Aged 16 and over Exclusion Criteria: Primary psychiatric diagnosis affecting skin (e.g., trichotillomania) Hair loss as a result of medical intervention or surgery (e.g., chemotherapy) The skin condition is secondary to other physical health problems (e.g., arthritis, cancer, chronic pain) Patient does not report any social distress as a result of their AA Currently undergoing other psychological therapy
Facility Information:
Facility Name
The University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S12LT
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital (Sheffield Teaching Hospital)
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7883407
Citation
Koo JY, Shellow WV, Hallman CP, Edwards JE. Alopecia areata and increased prevalence of psychiatric disorders. Int J Dermatol. 1994 Dec;33(12):849-50. doi: 10.1111/j.1365-4362.1994.tb01018.x.
Results Reference
background
PubMed Identifier
12786868
Citation
Ruiz-Doblado S, Carrizosa A, Garcia-Hernandez MJ. Alopecia areata: psychiatric comorbidity and adjustment to illness. Int J Dermatol. 2003 Jun;42(6):434-7. doi: 10.1046/j.1365-4362.2003.01340.x.
Results Reference
background
PubMed Identifier
21565463
Citation
Carleton RN, Collimore KC, McCabe RE, Antony MM. Addressing revisions to the Brief Fear of Negative Evaluation scale: measuring fear of negative evaluation across anxiety and mood disorders. J Anxiety Disord. 2011 Aug;25(6):822-8. doi: 10.1016/j.janxdis.2011.04.002. Epub 2011 Apr 16.
Results Reference
background
PubMed Identifier
22623334
Citation
Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.
Results Reference
background
PubMed Identifier
16443717
Citation
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
Results Reference
background
PubMed Identifier
10568646
Citation
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
Results Reference
background
PubMed Identifier
8033378
Citation
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
Results Reference
background
Citation
Beecham, J. and Knapp, M. (2001) Costing psychiatric interventions, in G. Thornicroft (ed.) Measuring Mental Health Needs, Gaskell, 2nd edition, 200-224.
Results Reference
background
PubMed Identifier
11983645
Citation
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
Results Reference
background

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The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata

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