Alopecia AreataNCT03873155
The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata
A study testing Mindfulness Based Cognitive Therapy in people with Alopecia Areata and Social Anxiety, run by University of Sheffield at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata, Social Anxiety
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Mar 2019to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The University of Sheffield
Sheffield, South Yorkshire, S12LT
Royal Hallamshire Hospital (Sheffield Teaching Hospital)
Sheffield, South Yorkshire
About this study
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.
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.
Read the 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.
- Conditions
- Alopecia Areata, Social Anxiety
- Being tested
- Mindfulness Based Cognitive Therapy
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Daily for 20 weeks (baseline-intervention-follow-up)
Secondary outcomes (8)
Social Anxiety
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").
Measured: Weekly for 21 weeks (baseline-intervention-follow-up)
Mindfulness
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").
Measured: Weekly for 21 weeks (baseline-intervention-follow-up)
Mindfulness
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").
Measured: 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
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").
Measured: 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
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").
Measured: 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)
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").
Measured: 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
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.
Measured: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
Work and social adjustment
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.
Measured: 3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start14 Mar 2019
- Primary completion20 Aug 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Alopecia UK
- Responsible party
- Principal investigator, Andrew Thompson, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873155
- Sponsor's protocol ID
- 230374
- Status last verified
- Sep 2019
- First submitted
- 4 Mar 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7883407Ruiz-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.
PubMed 12786868Carleton 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.
PubMed 21565463Baer 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.
PubMed 22623334Baer 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.
PubMed 16443717Spitzer 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.
PubMed 10568646Finlay 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.
PubMed 8033378Beecham, J. and Knapp, M. (2001) Costing psychiatric interventions, in G. Thornicroft (ed.) Measuring Mental Health Needs, Gaskell, 2nd edition, 200-224.
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.
PubMed 11983645
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03873155
- Acronym / sponsor ID
- 230374
- Conditions
- Alopecia Areata, Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Alopecia UK
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based cognitive therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyThere 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. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyMindfulness 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. | Behavioural | Mindfulness-based cognitive therapy |
Primary outcome
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
8 secondary outcomes
Social Anxiety
Time frame: Weekly for 21 weeks (baseline-intervention-follow-up)
Mindfulness
Time frame: Weekly for 21 weeks (baseline-intervention-follow-up)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 7883407Koo 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.
- Background: PubMed 12786868Ruiz-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.
- Background: PubMed 21565463Carleton 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.
- Background: PubMed 22623334Baer 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.
- Background: PubMed 16443717Baer 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.
- Background: PubMed 10568646Spitzer 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.
- Background: PubMed 8033378Finlay 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.
- BackgroundBeecham, J. and Knapp, M. (2001) Costing psychiatric interventions, in G. Thornicroft (ed.) Measuring Mental Health Needs, Gaskell, 2nd edition, 200-224.
- Background: PubMed 11983645Mundt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Alopecia Areata and Social Anxiety, run by University of Sheffield at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social anxiety (idiosyncratic measure) (time frame: Daily for 20 weeks (baseline-intervention-follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873155, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.