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

NCT04739228 | Completed DMC

• 1 other identifier: GDP_2016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Emotional Stress; Skin Diseases; Disclosure

Keywords

Dermatology; Guided Writing Disclosure Protocol; Psychological Distress; Positive Psychology; Randomized-controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Guided Written Disclosure Protocol Group

EXPERIMENTAL

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

Active Control Group

ACTIVE COMPARATOR

Behavioral: Active Control Group

Interventions

Guided Written Disclosure Protocol Group BEHAVIORAL

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.

Guided Written Disclosure Protocol Group

Active Control Group BEHAVIORAL

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.

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years;
• Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

Rome, 00167, Italy

Location

Related Publications (2)

• 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.

  PMID: 11906981 RESULT

• 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.

  PMID: 19742069 RESULT

MeSH Terms

Conditions

Stress, Psychological; Skin Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Skin and Connective Tissue Diseases

Study Officials

• Luca Iani, PhD

  European University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: July 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after the study will be published
• Access Criteria: Through the depository Figshare

Locations

IT (1)