Clinical trial NCT03873155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Social Anxiety
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Alopecia UK
First posted: 2019-03-13
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in social anxiety (idiosyncratic measure)
timeFrame: Daily for 20 weeks (baseline-intervention-follow-up)
Secondary outcomes:
measure: Social Anxiety
timeFrame: Weekly for 21 weeks (baseline-intervention-follow-up)
measure: Mindfulness
timeFrame: Weekly for 21 weeks (baseline-intervention-follow-up)
measure: Mindfulness
timeFrame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
measure: Depression
timeFrame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
measure: Anxiety
timeFrame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
measure: Quality of life (dermatology-related)
timeFrame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later)
measure: Service use
timeFrame: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
measure: Work and social adjustment
timeFrame: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital (Sheffield Teaching Hospital)
state: South Yorkshire
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
citation: Beecham, J. and Knapp, M. (2001) Costing psychiatric interventions, in G. Thornicroft (ed.) Measuring Mental Health Needs, Gaskell, 2nd edition, 200-224.
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.