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

Alopecia Areata Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873155
• Other study ID #: 230374
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: September 23, 2019

Study information

• Verified date: September 2019
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 23, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Anxiety Disorders
• Social Anxiety

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital (Sheffield Teaching Hospital)	Sheffield	South Yorkshire
United Kingdom	The University of Sheffield	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Sheffield	Alopecia UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

Ruiz-Doblado S, Carrizosa A, García-Hernández MJ. Alopecia areata: psychiatric comorbidity and adjustment to illness. Int J Dermatol. 2003 Jun;42(6):434-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)