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

The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata: A Single Group Case Series.

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety; Alopecia Areata
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S12LT
      • The University of Sheffield
    • Sheffield, South Yorkshire, United Kingdom
      • Royal Hallamshire Hospital (Sheffield Teaching Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness-based cognitive therapy; 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.

Behavioral: Mindfulness Based Cognitive Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Daily for 20 weeks (baseline-intervention-follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	Weekly for 21 weeks (baseline-intervention-follow-up)
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").	Weekly for 21 weeks (baseline-intervention-follow-up)
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").	4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
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").	4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
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").	4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
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").	4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
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.	3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
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.	3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)

Collaborators and Investigators

• Sponsor: University of Sheffield
• Collaborators: Alopecia UK

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Beecham, J. and Knapp, M. (2001) Costing psychiatric interventions, in G. Thornicroft (ed.) Measuring Mental Health Needs, Gaskell, 2nd edition, 200-224.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Anxiety Disorders; Alopecia; Alopecia Areata
• Other Study ID Numbers: 230374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No