AlopeciaNCT04205214
A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia
A study testing Integrative Cognitive Behavioural Therapy in people with Alopecia, run by City, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Integrative Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2018to 13 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
- Fluent in Written and Verbal English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study
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.
Read the 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.
- Conditions
- Alopecia
- Being tested
- Integrative Cognitive Behavioural Therapy
- Keywords
- Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology
- Medical subject headings
- Alopecia, Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety And Depression Scale (HADS)
Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Measured: 12 weeks
Perceived Stress Scale (PSS)
Psychological Measure: Self-reported questionnaire measuring perceived stress
Measured: 12 weeks
Dermatology Life Quality Index (DLQI)
Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life
Measured: 12 weeks
Severity of Alopecia Tool (SALT) Scalp Assessment
Physical Measure: Percentage of total hair loss
Measured: 12 weeks
Blood Test
Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)
Measured: 12 weeks
Secondary outcomes (1)
Physical Measures
Medical Photography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Dec 2018
- Primary completion2 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sharon Hart, Doctorate, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205214
- Sponsor's protocol ID
- PSYETH (P/F) 17/18 177
- Status last verified
- Jan 2020
- First submitted
- 10 Nov 2019
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04205214
- Acronym / sponsor ID
- PSYETH (P/F) 17/18 177
- Conditions
- Alopecia
- Keywords
- Cognitive Behavioural Therapy, Mindfulness, Narrative Therapy, Alopecia Areata, Alopecia Universalis, Alopecia Totalis, Psychology, Health Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Cognitive Behavioural Therapy Intervention Group | Experimental | Behavioral: Integrative Cognitive Behavioural TherapyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
- Fluent in Written and Verbal English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Cognitive Behavioural TherapyThis 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. | Behavioural | Integrative Cognitive Behavioural Therapy Intervention Group |
Primary outcome
Hospital Anxiety And Depression Scale (HADS)
Time frame: 12 weeks
Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Perceived Stress Scale (PSS)
Time frame: 12 weeks
Psychological Measure: Self-reported questionnaire measuring perceived stress
Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks
Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life
Severity of Alopecia Tool (SALT) Scalp Assessment
Time frame: 12 weeks
Physical Measure: Percentage of total hair loss
Blood Test
Time frame: 12 weeks
Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)
1 secondary outcome
Physical Measures
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Hart, Doctorate principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Cognitive Behavioural Therapy in people with Alopecia, run by City, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety And Depression Scale (HADS) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.