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

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ClinicalTrials.gov Identifier: NCT03873155
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Alopecia UK
Information provided by (Responsible Party):
Andrew Thompson, University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Social Anxiety Behavioral: Mindfulness Based Cognitive Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: No party will be masked in this study. There is only one arm and participants will act as their own controls
Primary Purpose: Treatment
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.
Actual Study Start Date : March 14, 2019
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Social Anxiety [ Time Frame: Weekly for 21 weeks (baseline-intervention-follow-up) ]
    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").

  2. Mindfulness [ Time Frame: Weekly for 21 weeks (baseline-intervention-follow-up) ]
    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").

  3. Mindfulness [ Time Frame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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. Depression [ Time Frame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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").

  5. Anxiety [ Time Frame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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").

  6. Quality of life (dermatology-related) [ Time Frame: 4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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").

  7. Service use [ Time Frame: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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.

  8. Work and social adjustment [ Time Frame: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later) ]
    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.



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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873155


Locations
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United Kingdom
The University of Sheffield
Sheffield, South Yorkshire, United Kingdom, S12LT
Royal Hallamshire Hospital (Sheffield Teaching Hospital)
Sheffield, South Yorkshire, United Kingdom
Sponsors and Collaborators
University of Sheffield
Alopecia UK

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

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Responsible Party: Andrew Thompson, Principal Investigator, University of Sheffield
ClinicalTrials.gov Identifier: NCT03873155     History of Changes
Other Study ID Numbers: 230374
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Anxiety Disorders
Mental Disorders
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical