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NCT Number: NCT04739228

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.

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Key information

Conditions

Psychological Distress Behavior Behavioral Symptoms Disclosure Emotional Stress Skin Diseases Skin and Connective Tissue Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

Rome, 00167, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

European University of Rome

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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