- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04132973
Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions
An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Zjednoczone Królestwo, S1 2LT
- The University of Sheffield
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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).
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Acceptability of Intervention Overall
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Elaine N Clarke, PhD, University of Sheffield
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 163781
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .