Clinical trial NCT04739228: Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial
Official title: Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Emotional Stress
Skin Diseases
Disclosure
Keywords: Dermatology
Guided Writing Disclosure Protocol
Psychological Distress
Positive Psychology
Randomized-controlled Trial
Lead sponsor: European University of Rome
Sponsor class: OTHER
Collaborators: name: IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
First posted: 2021-02-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
measure: 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.
timeFrame: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Secondary outcomes:
measure: 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.
timeFrame: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
measure: 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.
timeFrame: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
measure: 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.
timeFrame: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
Study officials:
affiliation: European University of Rome
name: Luca Iani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gidron Y, Duncan E, Lazar A, Biderman A, Tandeter H, Shvartzman P. Effects of guided written disclosure of stressful experiences on clinic visits and symptoms in frequent clinic attenders. Fam Pract. 2002 Apr;19(2):161-6. doi: 10.1093/fampra/19.2.161.
citation: Mogk C, Otte S, Reinhold-Hurley B, Kroner-Herwig B. Health effects of expressive writing on stressful or traumatic experiences - a meta-analysis. Psychosoc Med. 2006 Nov 16;3:Doc06.