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Clinical Trials/NCT03873155
NCT03873155CompletedNot Applicable

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

University of Sheffield2 sites in 1 country6 target enrollmentStarted: March 14, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
2
Primary Endpoint
Change in social anxiety (idiosyncratic measure)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

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

Eligibility Criteria

Ages
16 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Mindfulness Based Cognitive Therapy (Behavioral)

Outcomes

Primary Outcomes

Change in social anxiety (idiosyncratic measure)

Time Frame: Daily for 20 weeks (baseline-intervention-follow-up)

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

Secondary Outcomes

  • Social Anxiety(Weekly for 21 weeks (baseline-intervention-follow-up))
  • 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))
  • Quality of life (dermatology-related)(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(3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later))
  • 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))
  • Work and social adjustment(3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Mindfulness(Weekly for 21 weeks (baseline-intervention-follow-up))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrew Thompson

Principal Investigator

University of Sheffield

Study Sites (2)

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