A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Behavioral: Integrative Cognitive Behavioural Therapy

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Royal Free Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Cognitive Behavioural Therapy Intervention Group; 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; 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.
No Intervention: Wait List Control Group; 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?

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

Collaborators and Investigators

• Sponsor: City, University of London
• Collaborators: Royal Free Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Sharon Hart, Doctorate, Royal Free Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Mindfulness; Cognitive Behavioural Therapy; Health Psychology; Alopecia Areata; Psychology; Narrative Therapy; Alopecia Universalis; Alopecia Totalis
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: PSYETH (P/F) 17/18 177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No