A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205214
• Other study ID #: PSYETH (P/F) 17/18 177
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 13, 2020

Study information

• Verified date: January 2020
• Source: City, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 13, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

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.

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
City, University of London	Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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