Disclosure, Emotional Stress, Psychological Distress, Skin Diseases
Conditions
Keywords
Dermatology, Guided Writing Disclosure Protocol, Psychological Distress, Positive Psychology, Randomized-controlled Trial
Brief summary
We conducted a randomized-controlled trial of Guided Written Disclosure Protocol for dermatological patients with the aim of reducing psychological distress, expressive suppression, and skin-related symptoms, and improving spiritual well-being, cognitive reappraisal, and sense of coherence.
Detailed description
Sample size assessment: A recent meta-analysis reported a study which showed that Guided Written Disclosure Protocol reach on effect size of 0.89 on psychosocial outcomes (Gidron et al., 2002; Mogk et al., 2006). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 34 participants to detect effect sizes of 0.89 and higher. Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced. Statistical analysis plan: We conducted a 2 (group) X 2 (time \[pre-treatment vs. post-treatment\]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables.
Interventions
BEHAVIORALGuided Written Disclosure Protocol Group
The writing task consists of three sessions of 20 minutes each, with an interval of one week between each other. In the first session, patients were asked to describe the onset of illness, describing chronologically and detailed places, images, sounds and actions, as they are followed and detached from the emotions. In the second session, the patients were asked to write about thoughts and emotions felt during the illness experience, talking about the impact that illness had on their daily lives and how it had changed their personal attitude to life itself. In the third and final session, the patients were asked to analyze subjective new skills acquired.
BEHAVIORALActive Control Group
The writing task also consists of three sessions of 20 minutes each, with an interval of one week between each other. In all three writing sessions, patients were asked to report the daily activities during the last week, without focusing on the emotional aspects.
Sponsors
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
European University of Rome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years; * Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.
Exclusion criteria
* Patients with certified mental disorders (e.g., psychotic illness, major depressive disorder) * Patients undergoing psychotherapy for at least 6 months in the last 3 years; * Patients who currently receive psychopharmacological treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Pre-test to Post-test and Follow-up in Spiritual Well-Being, which will be reported in the outcome measure results data table as means and standard deviations. | Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment) | Spiritual well-being will be measured with the FACIT-Sp (minimum value=0; maximum value=48, with higher scores indicating a better outcome), a questionnaire assessing faith, peace and meaning |
| Change from Pre-test to Post-test and Follow-up in Psychological Distress, which will be reported in the outcome measure results data table as means and standard deviations. | Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment) | Psychological distress will be measured with the GHQ-12 (minimum value=1; maximum value=4, with higher score indicating greater outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Pre-test to Post-test and Follow-up in Emotion Regulation, which will be reported in the outcome measure results data table as means and standard deviations. | Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment) | Emotion regulation will be measured with ERQ (minimum value=1; maximum value=7), a questionnaire assessing expressive suppression and cognitive reappraisal. |
| Change from Pre-test to Post-test and Follow-up in Skin-related Quality of Life, which will be reported in the outcome measure results data table as means and standard deviations. | Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment) | Skin-related Quality of Life will be measured with Skindex 29 (minimum value=1; maximum value=5, with higher score indicating a worse outcome), a questionnaire assessing symptoms, emotions, and functioning. |
| Change from Pre-test to Post-test and Follow-up in Sense of Coherence, which will be reported in the outcome measure results data table as means and standard deviations. | Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment) | Sense of Coherence will be measured with SOC-13 (minimum value=1; maximum value=7, with higher score indicating a greater outcome), a questionnaire assessing comprehensibility and meaningfulness of human experience |
Countries
Italy
Outcome results
None listed