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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Psychological Distress; Emotional Stress; Disclosure
• Intervention / Treatment: Behavioral: Guided Written Disclosure Protocol Group; Behavioral: Active Control Group

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00167
    • IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Guided 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.
ACTIVE_COMPARATOR: Active Control Group	Behavioral: Active 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
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.	Psychological distress will be measured with the GHQ-12 (minimum value=1; maximum value=4, with higher score indicating greater outcome).	Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Emotion regulation will be measured with ERQ (minimum value=1; maximum value=7), a questionnaire assessing expressive suppression and cognitive reappraisal.	Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
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.	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.	Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
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.	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	Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)

Collaborators and Investigators

• Sponsor: European University of Rome
• Collaborators: IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Positive Psychology; Psychological Distress; Dermatology; Guided Writing Disclosure Protocol; Randomized-controlled Trial
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: GDP_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Data will become available after the study will be published
• IPD Sharing Access Criteria: Through the depository Figshare
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No