A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

NCT04205214 | Completed

• 1 other identifier: PSYETH (P/F) 17/18 177
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Physical Measures

  12 weeks

Study Arms (2)

Integrative Cognitive Behavioural Therapy Intervention Group

EXPERIMENTAL

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

Wait List Control Group

NO INTERVENTION

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.

Interventions

Integrative Cognitive Behavioural Therapy BEHAVIORAL

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.

Integrative Cognitive Behavioural Therapy Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Other
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
• Fluent in Written and Verbal English

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Alopecia; Alopecia Areata; Alopecia universalis

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon Hart, Doctorate

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are not aware of their allocation to the intervention group or control group. All
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: December 19, 2019
• Study Start: December 1, 2018
• Primary Completion: February 2, 2020
• Study Completion: February 13, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)