A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

Not Applicable

Completed

• Conditions: Alopecia
• Interventions: Behavioral: Integrative Cognitive Behavioural Therapy

• Registration Number: NCT04205214
• Lead Sponsor: City, University of London

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Status Verified: 2020-01
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-13
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrative Cognitive Behavioural Therapy Intervention Group	Integrative Cognitive Behavioural Therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physical Measures	12 weeks	Medical Photography

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom