Dermatologic DiseaseNCT04132973
Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions
A study testing Compassion for Skin Conditions in people with Dermatologic Disease and Depression, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
The study aims to explore whether an online compassion-based guided self-help intervention is perceived as acceptable to people with heterogeneous skin conditions, in terms of retention rates and explicit feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Disease, Depression
- What is being tested?
- Compassion for Skin Conditions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2019to 2 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- self-report of currently having a skin condition that has been present for at least the last six months and has been diagnosed by a medical professional.
- scored 10-20 (inclusive) on DASS-DEP (depression subscale of Depression Anxiety Stress Scales).
Who cannot join
- currently receiving a psychological therapy for a mental health problem.
- current diagnosis of a serious mental illness (e.g. psychosis or bipolar disorder).
- current diagnosis of a drug or alcohol problem.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Sheffield
Sheffield, South Yorkshire, S1 2LT
About this study
Official title: An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
The study aims to explore whether an online compassion-based guided self-help intervention is perceived as acceptable to people with heterogeneous skin conditions, in terms of retention rates and explicit feedback. The study also aims to investigate the feasibility of providing online compassion-based self-help and email guidance. Changes in depression, self-compassion and skin-related distress will be assessed to give an estimate of likely effect sizes for future research
Read the detailed description
The study will investigate an online compassion-based self-help intervention with email guidance with people with skin conditions who are experiencing depressive symptoms. As the study aims to investigate a novel intervention, the study will be an acceptability and feasibility study that uses a pre-post design. Participants with skin conditions will be recruited from the general population using online methods (social media and advertisements on skin condition charities/organisations websites). Participants will complete baseline measures using Qualtrics and then be able to commence a six-week online intervention, consisting of a dedicated website containing six self-help sessions to work through. Regular guidance will be provided by the researcher via email. The self-help exercises in the current study will consist of a number of exercises derived from Compassion Focused Therapy (CFT)/Compassionate Mind Training, such as using soothing rhythm breathing, compassionate imagery and compassionate writing. Explicit feedback will be sought from participants at the end of each session, and at the end of the intervention overall. Engagement with the website will be monitored via user logins and this will be used to calculate the retention rate for the intervention. Post-intervention measures will be collected one week after the end of the intervention. All participants will be provided with signposting information relating to mental health and skin conditions, and advised to see their GP if they require any further support with their physical or mental health.
Intervention The guided self-help intervention will consist of six online sessions of self-help information for participants to work through, plus activities to carry out in-between sessions. The intervention will consist of psycho-education material, self-monitoring, and compassion-inducing exercises from CFT. The self-help exercises in the intervention will be evidence-based as being effective for depression: the compassion-focused imagery exercises and the letter-writing exercise will be based on those used in published studies. Other exercises, such as thought monitoring and relapse prevention planning, are commonly used in cognitive behavioural therapy (CBT) and, as CFT is an adapted form of CBT, will be included in the current self-help intervention. The session content and homework exercises will build on previous sessions and homework, so there will be a clear sense of progression through the intervention. In addition, imagery and written homework exercises will be alternated, to provide variety and keep participants engaged in the intervention. Examples relating to skin conditions will be given throughout the self-help materials. Expert feedback regarding the content of the website has been sourced through personal contacts and social media. Feedback has already been gathered from three people with skin conditions. Changes to the website deemed necessary based on their feedback have been made.
Data analysis strategy Text responses from participants' feedback on the intervention overall will be analysed using content analysis to identify helpful aspects of the intervention and areas for improvement. Quantitative data (outcome measures and acceptability ratings) will be screened for outliers and missing values, and descriptive statistics will be conducted for all variables. The data will be tested for the assumption of normality. Paired t-tests will be used to test for differences in participants' psychological outcome measures before and after the intervention. This information will also be used to calculate effect sizes (dz) for changes in scores on each outcome measure. Intention-to-treat and completer analyses will be carried out.
- Conditions
- Dermatologic Disease, Depression
- Being tested
- Compassion for Skin Conditions
- Keywords
- acceptability, feasibility, self-management
- Medical subject headings
- Skin Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion for Skin ConditionsBehavioural
Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
| Study group | Role | What they receive |
|---|---|---|
| Compassion guided self-help | Experimental | Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Receives: Behavioral: Compassion for Skin Conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Overall
Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).
Measured: Week 6 for each participant (rolling recruitment).
Acceptability of Session 1
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 1
Acceptability of Session 2
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 8
Acceptability of Session 3
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 15
Acceptability of Session 4
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 22
Acceptability of Session 5
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 29
Acceptability of Session 6
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Measured: Day 36
Secondary outcomes (3)
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
Self-report measure of depression. Measure ranges from 0 to 42, with higher scores indicating higher levels of depressive symptomatology.
Measured: Days 1 and 43.
Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
Self-report measure of self-compassion. Measure ranges from 26 to 130, with higher scores indicating higher levels of self-compassion.
Measured: Days 1 and 43.
Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
Self-report measure of impact of skin condition on quality of life. Measure ranges from 0 to 30, with higher scores indicating higher effect of the skin condition on the person's life.
Measured: Days 1 and 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start12 Nov 2019
- Primary completion23 Mar 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dermatologic DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an acceptability and feasibility study of a novel healthcare intervention, therefore there is only one study group.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine N Clarke, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132973
- Sponsor's protocol ID
- 163781
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 26 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be made available to maintain confidentiality, but aggregated data may be made available from the lead researcher upon reasonable request.
Publications
Kelly AC, Zuroff DC, Shapira LB. Soothing oneself and resisting self-attacks: The treatment of two intrapersonal deficits in depression vulnerability. Cognitive Therapy and Research 33: 301-313, 2009.
Shapira LB, Mongrain M. The benefits of self-compassion and optimism exercises for individuals vulnerable to depression. The Journal of Positive Psychology 5: 337-389, 2010.
McEwan K, Gilbert P. A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. Psychol Psychother. 2016 Jun;89(2):239-43. doi: 10.1111/papt.12078. Epub 2015 Oct 10.
PubMed 26454144Gilbert P, Irons C. Focused therapies and compassionate mind training for shame and self-attacking. In: Gilbert P, editor. Compassion: Conceptualisations, Research and Use in Psychotherapy. Hove: Routledge; 2005. p 263-325.
Gilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.
Clarke EN, Norman P, Thompson AR. Online compassion-based self-help for depression in people with skin conditions: a feasibility study. Pilot Feasibility Stud. 2024 Apr 16;10(1):63. doi: 10.1186/s40814-024-01486-4.
PubMed 38627850
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
- ClinicalTrials.gov ID
- NCT04132973
- Acronym / sponsor ID
- 163781
- Conditions
- Dermatologic Disease, Depression
- Keywords
- acceptability, feasibility, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore whether an online compassion-based guided self-help intervention is perceived as acceptable to people with heterogeneous skin conditions, in terms of retention rates and explicit feedback. The study also aims to investigate the feasibility of providing online compassion-based self-help and email guidance. Changes in depression, self-compassion and skin-related distress will be assessed to give an estimate of likely effect sizes for future research
Detailed description
The study will investigate an online compassion-based self-help intervention with email guidance with people with skin conditions who are experiencing depressive symptoms. As the study aims to investigate a novel intervention, the study will be an acceptability and feasibility study that uses a pre-post design. Participants with skin conditions will be recruited from the general population using online methods (social media and advertisements on skin condition charities/organisations websites). Participants will complete baseline measures using Qualtrics and then be able to commence a six-week online intervention, consisting of a dedicated website containing six self-help sessions to work through. Regular guidance will be provided by the researcher via email. The self-help exercises in the current study will consist of a number of exercises derived from Compassion Focused Therapy (CFT)/Compassionate Mind Training, such as using soothing rhythm breathing, compassionate imagery and compassionate writing. Explicit feedback will be sought from participants at the end of each session, and at the end of the intervention overall. Engagement with the website will be monitored via user logins and this will be used to calculate the retention rate for the intervention. Post-intervention measures will be collected one week after the end of the intervention. All participants will be provided with signposting information relating to mental health and skin conditions, and advised to see their GP if they require any further support with their physical or mental health.
Intervention The guided self-help intervention will consist of six online sessions of self-help information for participants to work through, plus activities to carry out in-between sessions. The intervention will consist of psycho-education material, self-monitoring, and compassion-inducing exercises from CFT. The self-help exercises in the intervention will be evidence-based as being effective for depression: the compassion-focused imagery exercises and the letter-writing exercise will be based on those used in published studies. Other exercises, such as thought monitoring and relapse prevention planning, are commonly used in cognitive behavioural therapy (CBT) and, as CFT is an adapted form of CBT, will be included in the current self-help intervention. The session content and homework exercises will build on previous sessions and homework, so there will be a clear sense of progression through the intervention. In addition, imagery and written homework exercises will be alternated, to provide variety and keep participants engaged in the intervention. Examples relating to skin conditions will be given throughout the self-help materials. Expert feedback regarding the content of the website has been sourced through personal contacts and social media. Feedback has already been gathered from three people with skin conditions. Changes to the website deemed necessary based on their feedback have been made.
Data analysis strategy Text responses from participants' feedback on the intervention overall will be analysed using content analysis to identify helpful aspects of the intervention and areas for improvement. Quantitative data (outcome measures and acceptability ratings) will be screened for outliers and missing values, and descriptive statistics will be conducted for all variables. The data will be tested for the assumption of normality. Paired t-tests will be used to test for differences in participants' psychological outcome measures before and after the intervention. This information will also be used to calculate effect sizes (dz) for changes in scores on each outcome measure. Intention-to-treat and completer analyses will be carried out.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an acceptability and feasibility study of a novel healthcare intervention, therefore there is only one study group.
| Arm | Type | Receives |
|---|---|---|
| Compassion guided self-help | Experimental | Behavioral: Compassion for Skin ConditionsParticipants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-report of currently having a skin condition that has been present for at least the last six months and has been diagnosed by a medical professional.
- scored 10-20 (inclusive) on DASS-DEP (depression subscale of Depression Anxiety Stress Scales).
Key exclusion criteria (3 listed)
- currently receiving a psychological therapy for a mental health problem.
- current diagnosis of a serious mental illness (e.g. psychosis or bipolar disorder).
- current diagnosis of a drug or alcohol problem.
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 |
|---|---|---|
| Compassion for Skin ConditionsOnline guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010). | Behavioural | Compassion guided self-help |
Primary outcome
Acceptability of Intervention Overall
Time frame: Week 6 for each participant (rolling recruitment).
Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).
Acceptability of Session 1
Time frame: Day 1
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Acceptability of Session 2
Time frame: Day 8
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Acceptability of Session 3
Time frame: Day 15
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Acceptability of Session 4
Time frame: Day 22
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Acceptability of Session 5
Time frame: Day 29
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
Acceptability of Session 6
Time frame: Day 36
Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.
3 secondary outcomes
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
Time frame: Days 1 and 43.
Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
Time frame: Days 1 and 43.
Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
Time frame: Days 1 and 43.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundKelly AC, Zuroff DC, Shapira LB. Soothing oneself and resisting self-attacks: The treatment of two intrapersonal deficits in depression vulnerability. Cognitive Therapy and Research 33: 301-313, 2009.
- BackgroundShapira LB, Mongrain M. The benefits of self-compassion and optimism exercises for individuals vulnerable to depression. The Journal of Positive Psychology 5: 337-389, 2010.
- Background: PubMed 26454144McEwan K, Gilbert P. A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. Psychol Psychother. 2016 Jun;89(2):239-43. doi: 10.1111/papt.12078. Epub 2015 Oct 10.
- BackgroundGilbert P, Irons C. Focused therapies and compassionate mind training for shame and self-attacking. In: Gilbert P, editor. Compassion: Conceptualisations, Research and Use in Psychotherapy. Hove: Routledge; 2005. p 263-325.
- BackgroundGilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.
- Derived from this study: PubMed 38627850Clarke EN, Norman P, Thompson AR. Online compassion-based self-help for depression in people with skin conditions: a feasibility study. Pilot Feasibility Stud. 2024 Apr 16;10(1):63. doi: 10.1186/s40814-024-01486-4.
- Individual participant dataSharing planned: No. Individual patient data will not be made available to maintain confidentiality, but aggregated data may be made available from the lead researcher upon reasonable request.
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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.
Elaine N Clarke, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion for Skin Conditions in people with Dermatologic Disease and Depression, run by University of Sheffield 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 3 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 26 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability of Intervention Overall (time frame: Week 6 for each participant (rolling recruitment).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04132973, which also lists 6 linked publications.
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 26 Oct 2021.