Depression, Dermatologic Disease
Conditions
Keywords
acceptability, feasibility, self-management
Brief 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. 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.
Interventions
BEHAVIORALCompassion for Skin Conditions
Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Sponsors
University of Sheffield
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is an acceptability and feasibility study of a novel healthcare intervention, therefore there is only one study group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Session 6 | 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. |
| Acceptability of Session 3 | 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 | 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 | 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 Intervention Overall | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks. | Days 1 and 43. | Self-report measure of self-compassion. Measure ranges from 26 to 130, with higher scores indicating higher levels of self-compassion. |
| Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks. | Days 1 and 43. | 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. |
| Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks. | Days 1 and 43. | Self-report measure of depression. Measure ranges from 0 to 42, with higher scores indicating higher levels of depressive symptomatology. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Compassion Guided Self-help Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.
Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010). | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Compassion Guided Self-help |
|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized British African | 1 participants |
| Race/Ethnicity, Customized British Pakistani | 1 participants |
| Race/Ethnicity, Customized Japanese | 1 participants |
| Race/Ethnicity, Customized Mixed heritage | 2 participants |
| Race/Ethnicity, Customized Not specified | 1 participants |
| Race/Ethnicity, Customized White | 28 participants |
| Region of Enrollment Italy | 1 participants |
| Region of Enrollment Malaysia | 1 participants |
| Region of Enrollment Spain | 1 participants |
| Region of Enrollment United Kingdom | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 3 Participants |
| Skin condition (self-reported) Eczema | 16 participants |
| Skin condition (self-reported) Other | 11 participants |
| Skin condition (self-reported) Psoriasis | 13 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Acceptability of Intervention Overall
Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).
Time frame: Week 6 for each participant (rolling recruitment).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassion Guided Self-help | Acceptability of Intervention Overall | 11 Participants |
Primary
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 1 | 2.35 score on a scale | Standard Deviation 1.28 |
Primary
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 2 | 2.35 score on a scale | Standard Deviation 1.3 |
Primary
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.
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 3 | 2.56 score on a scale | Standard Deviation 1.13 |
Primary
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.
Time frame: Day 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 4 | 2.7 score on a scale | Standard Deviation 1.29 |
Primary
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.
Time frame: Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 5 | 2.43 score on a scale | Standard Deviation 1.36 |
Primary
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.
Time frame: Day 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Acceptability of Session 6 | 2.97 score on a scale | Standard Deviation 1.25 |
Secondary
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.
Time frame: Days 1 and 43.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks. | -7.75 score on a scale | Standard Deviation 7.03 |
Secondary
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.
Time frame: Days 1 and 43.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks. | -6.38 score on a scale | Standard Deviation 6.61 |
Secondary
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.
Time frame: Days 1 and 43.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Guided Self-help | Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks. | 17.88 score on a scale | Standard Deviation 27.82 |