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

NCT ID: NCT03873155

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2019-09-23

Brief Summary

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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

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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.

Conditions

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Alopecia Areata Social Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No party will be masked in this study. There is only one arm and participants will act as their own controls

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alopecia UK

UNKNOWN

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

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Andrew Thompson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Sheffield

Sheffield, South Yorkshire, United Kingdom

Site Status

Royal Hallamshire Hospital (Sheffield Teaching Hospital)

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 7883407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12786868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21565463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22623334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16443717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10568646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8033378 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11983645 (View on PubMed)

Other Identifiers

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230374

Identifier Type: -

Identifier Source: org_study_id

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