A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

Study Overview
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Brief Summary
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This Randomised Control Trial (RCT) aims to test a novel Alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring Alopecia. The pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.

Detailed Description
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Alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. This pilot RCT aims to test a newly developed Alopecia-specific, psychological intervention with 8 patients diagnosed with enduring Alopecia. The intervention is an Integrative Cognitive Behavioural Therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. The trial will be delivered at The Dermatology Department at the Royal Free Hospital in Hampstead, London. The pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.

Official Title
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A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study

Conditions
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Alopecia

Intervention / Treatment
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* Behavioral: Integrative Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial Fluent in Written and Verbal English Exclusion Criteria: Another more dominant skin condition Another more dominant severe and enduring mental illness Women who are pregnant Learning difficulties, brain injuries or dementia Drug and alcohol dependency Received therapy in the last year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Cognitive Behavioural Therapy Intervention Group<br>The group receive 12 weekly individual Integrative Cognitive Behavioural Therapy sessions from the principal investigator and Trainee counselling Psychologist. The sessions last up to 60 minutes on a weekly basis. The participants in this group are required to complete self-reported questionnaires assessing: anxiety, depression, stress and quality of life. They are also required to attend a scalp assessment and undergo a blood test and medical photography. These assessments occur at the initial assessment prior to beginning the intervention and after the 12-week intervention. | Behavioral: Integrative Cognitive Behavioural Therapy<br>* This intervention involves the psychological intervention of Cognitive Behavioural Therapy. This intervention also includes third wave psychological interventions of Mindfulness and Narrative Therapy which has been found to be helpful for people with chronic health conditions and chronic skin conditions.<br>|
| No Intervention: Wait List Control Group<br>The group do not receive the intervention and are told that they can start the intervention after 12 weeks. The participants in this group are required to complete self-reported questionnaires assessing: anxiety, depression, stress and quality of life. They are also required to attend a scalp assessment and undergo a blood test and medical photography. These assessments occur at the initial assessment prior to beginning the intervention and after the 12-week waiting period. After this 12-week waiting period, they are offered the individual therapy and their data is added to the experimental group data. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety And Depression Scale (HADS) | Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms | 12 weeks | 
| Perceived Stress Scale (PSS) | Psychological Measure: Self-reported questionnaire measuring perceived stress | 12 weeks | 
| Dermatology Life Quality Index (DLQI) | Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life | 12 weeks | 
| Severity of Alopecia Tool (SALT) Scalp Assessment | Physical Measure: Percentage of total hair loss | 12 weeks | 
| Blood Test | Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Measures | Medical Photography | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology