Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial

Not Applicable

Completed

• Conditions: Disclosure; Psychological Distress; Emotional Stress; Skin Diseases
• Interventions: Behavioral: Guided Written Disclosure Protocol Group; Behavioral: Active Control Group

• Registration Number: NCT04739228
• Lead Sponsor: European University of Rome

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Written Disclosure Protocol Group	Guided Written Disclosure Protocol Group	Guided Written Disclosure Protocol is a short-term psychological intervention that stimulates emotional expression, promotes a cognitive reworking of stressful illness events and facilitates the integration between emotional and cognitive processing of traumatic experiences. Intervention aimed at enhancing patients' quality of life, psychological well-being, and emotional regulation, and reducing psychosocial distress.
Active Control Group	Active Control Group	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti; 🇮🇹 Rome, Italy