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

27 de setembro de 2021 atualizado por: University of Sheffield

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

Visão geral do estudo

Status

Concluído

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

34

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • South Yorkshire
      • Sheffield, South Yorkshire, Reino Unido, S1 2LT
        • The University of Sheffield

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Compassion guided self-help
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher.
Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of Intervention Overall
Prazo: 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).
Week 6 for each participant (rolling recruitment).
Acceptability of Session 1
Prazo: 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.
Day 1
Acceptability of Session 2
Prazo: 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.
Day 8
Acceptability of Session 3
Prazo: 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.
Day 15
Acceptability of Session 4
Prazo: 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.
Day 22
Acceptability of Session 5
Prazo: 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.
Day 29
Acceptability of Session 6
Prazo: 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.
Day 36

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
Prazo: Days 1 and 43.
Self-report measure of depression. Measure ranges from 0 to 42, with higher scores indicating higher levels of depressive symptomatology.
Days 1 and 43.
Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
Prazo: 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.
Days 1 and 43.
Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
Prazo: 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.
Days 1 and 43.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Elaine N Clarke, PhD, University of Sheffield

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de novembro de 2019

Conclusão Primária (Real)

23 de março de 2020

Conclusão do estudo (Real)

2 de abril de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

17 de outubro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de outubro de 2019

Primeira postagem (Real)

21 de outubro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de setembro de 2021

Última verificação

1 de outubro de 2019

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Compassion for Skin Conditions

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