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

NCT03873155 | Completed

• 1 other identifier: 230374
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Alopecia Areata; Social Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Social Anxiety

  Weekly for 21 weeks (baseline-intervention-follow-up)

• Mindfulness

  Weekly for 21 weeks (baseline-intervention-follow-up)

• Mindfulness

  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

  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

  4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)

Study Arms (1)

Mindfulness-based cognitive therapy

EXPERIMENTAL

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

Interventions

Mindfulness Based Cognitive Therapy 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.

Mindfulness-based cognitive therapy

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sheffield: lead
• Alopecia UK: collaborator

Study Sites (2)

The University of Sheffield

Sheffield, South Yorkshire, S12LT, United Kingdom

Location

Royal Hallamshire Hospital (Sheffield Teaching Hospital)

Sheffield, South Yorkshire, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 7883407 BACKGROUND

• 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.

  PMID: 12786868 BACKGROUND

• 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.

  PMID: 21565463 BACKGROUND

• 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.

  PMID: 22623334 BACKGROUND

• 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.

  PMID: 16443717 BACKGROUND

• 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.

  PMID: 10568646 BACKGROUND

• 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.

  PMID: 8033378 BACKGROUND

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

  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.

  PMID: 11983645 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No party will be masked in this study. There is only one arm and participants will act as their own controls
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 13, 2019
• Study Start: March 14, 2019
• Primary Completion: August 20, 2019
• Study Completion: September 23, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

GB (2)