Clinical trial NCT04132973: Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions
Official title: An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatologic Disease
Depression
Keywords: acceptability
feasibility
self-management
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an acceptability and feasibility study of a novel healthcare intervention, therefore there is only one study group.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of Intervention Overall
timeFrame: Week 6 for each participant (rolling recruitment).
measure: Acceptability of Session 1
timeFrame: Day 1
measure: Acceptability of Session 2
timeFrame: Day 8
measure: Acceptability of Session 3
timeFrame: Day 15
measure: Acceptability of Session 4
timeFrame: Day 22
measure: Acceptability of Session 5
timeFrame: Day 29
measure: Acceptability of Session 6
timeFrame: Day 36
Secondary outcomes:
measure: Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
timeFrame: Days 1 and 43.
measure: Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
timeFrame: Days 1 and 43.
measure: Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
timeFrame: Days 1 and 43.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Elaine N Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Gilbert 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.
citation: Gilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.