A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

Sponsor

City, University of London (Other)

Overall Status

Completed

CT.gov ID

NCT04205214

Collaborator

Royal Free Hospital NHS Foundation Trust (Other)

Enrollment

Location

Arms

14.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia	Behavioral: Integrative Cognitive Behavioural Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Feb 2, 2020

Actual Study Completion Date :

Feb 13, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hospital Anxiety And Depression Scale (HADS) [12 weeks]
Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Perceived Stress Scale (PSS) [12 weeks]
Psychological Measure: Self-reported questionnaire measuring perceived stress
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)