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

NCT04132973 | Completed Results

• 1 other identifier: 163781
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Dermatologic Disease; Depression

Keywords

acceptability; feasibility; self-management

Outcome Measures

Primary Outcomes (7)

• Acceptability of Intervention Overall

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

  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.

  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.

  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.

  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.

  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.

  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.

  Day 36

Secondary Outcomes (3)

• Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.

  Days 1 and 43.

• Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.

  Days 1 and 43.

• Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.

  Days 1 and 43.

Study Arms (1)

Compassion guided self-help

EXPERIMENTAL

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

Behavioral: Compassion for Skin Conditions

Interventions

Compassion for Skin Conditions BEHAVIORAL

Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).

Compassion guided self-help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

The University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26454144 BACKGROUND

• 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.

  BACKGROUND

• Gilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.

  BACKGROUND

• 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.

  PMID: 38627850 DERIVED

MeSH Terms

Conditions

Skin Diseases; Depression

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Elaine Clarke
• Organization: The University of Sheffield

e.n.clarke@shef.ac.uk

01142226533

Study Officials

• Elaine N Clarke, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an acceptability and feasibility study of a novel healthcare intervention, therefore there is only one study group.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: November 12, 2019
• Primary Completion: March 23, 2020
• Study Completion: April 2, 2020
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)