Depression Clinical Trial
Official title:
An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
NCT number | NCT04132973 |
Other study ID # | 163781 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 12, 2019 |
Est. completion date | April 2, 2020 |
Verified date | October 2019 |
Source | University of Sheffield |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 34 |
Est. completion date | April 2, 2020 |
Est. primary completion date | March 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The University of Sheffield | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Sheffield |
United Kingdom,
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.
Gilbert P. Compassion Focused Therapy: The CBT distinctive features series. Hove: Routledge; 2010. 237 p.
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.
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. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
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. | Day 1 | |
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. | Day 8 | |
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. | Day 15 | |
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. | Day 22 | |
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. | Day 29 | |
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. | Day 36 | |
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. | Days 1 and 43. | |
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. | Days 1 and 43. | |
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. | Days 1 and 43. |
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