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A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

Primary Purpose

Alopecia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Integrative Cognitive Behavioural Therapy
Sponsored by
City, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia focused on measuring Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrative Cognitive Behavioural Therapy Intervention Group

Wait List Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical Measures
Medical Photography

Full Information

First Posted
November 10, 2019
Last Updated
September 21, 2020
Sponsor
City, University of London
Collaborators
Royal Free Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04205214
Brief Title
A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia
Official Title
A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City, University of London
Collaborators
Royal Free Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants are not aware of their allocation to the intervention group or control group. All
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Cognitive Behavioural Therapy Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Cognitive Behavioural Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety And Depression Scale (HADS)
Description
Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Time Frame
12 weeks
Title
Perceived Stress Scale (PSS)
Description
Psychological Measure: Self-reported questionnaire measuring perceived stress
Time Frame
12 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life
Time Frame
12 weeks
Title
Severity of Alopecia Tool (SALT) Scalp Assessment
Description
Physical Measure: Percentage of total hair loss
Time Frame
12 weeks
Title
Blood Test
Description
Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical Measures
Description
Medical Photography
Time Frame
12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Other
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Hart, Doctorate
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

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