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Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions

Primary Purpose

Dermatologic Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compassion for Skin Conditions
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatologic Disease focused on measuring acceptability, feasibility, self-management

Eligibility Criteria

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

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.

Sites / Locations

  • The University of Sheffield

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compassion guided self-help

Arm Description

Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.

Outcomes

Primary Outcome Measures

Acceptability of Intervention Overall
Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 17, 2019
Last Updated
September 27, 2021
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT04132973
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
April 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sheffield

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Disease, Depression
Keywords
acceptability, feasibility, self-management

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion guided self-help
Arm Type
Experimental
Arm Description
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.
Intervention Type
Behavioral
Intervention Name(s)
Compassion for Skin Conditions
Intervention Description
Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Primary Outcome Measure Information:
Title
Acceptability of Intervention Overall
Description
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).
Title
Acceptability of Session 1
Description
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
Title
Acceptability of Session 2
Description
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
Title
Acceptability of Session 3
Description
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
Title
Acceptability of Session 4
Description
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
Title
Acceptability of Session 5
Description
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
Title
Acceptability of Session 6
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
Description
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.
Title
Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
Description
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.
Title
Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine N Clarke, PhD
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S1 2LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
26454144
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.
Results Reference
background
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.
Results Reference
background
Citation
Gilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.
Results Reference
background

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Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions

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