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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04205214
Enrollment
15
Registered
2019-12-19
Start date
2018-12-01
Completion date
2020-02-13
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Keywords

Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology

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.

Interventions

BEHAVIORALIntegrative 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.

Sponsors

Royal Free Hospital NHS Foundation Trust
CollaboratorOTHER
City, University of London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The participants are not aware of their allocation to the intervention group or control group. All

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety And Depression Scale (HADS)12 weeksPsychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Perceived Stress Scale (PSS)12 weeksPsychological Measure: Self-reported questionnaire measuring perceived stress
Dermatology Life Quality Index (DLQI)12 weeksPsychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life
Severity of Alopecia Tool (SALT) Scalp Assessment12 weeksPhysical Measure: Percentage of total hair loss
Blood Test12 weeksPhysical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)

Secondary

MeasureTime frameDescription
Physical Measures12 weeksMedical Photography

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026