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

Primary Purpose

Psychological Distress, Emotional Stress, Skin Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Guided Written Disclosure Protocol Group
Active Control Group
Sponsored by
European University of Rome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological Distress focused on measuring Dermatology, Guided Writing Disclosure Protocol, Psychological Distress, Positive Psychology, Randomized-controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Written Disclosure Protocol Group

Active Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
February 1, 2021
Last Updated
February 3, 2021
Sponsor
European University of Rome
Collaborators
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
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1. Study Identification

Unique Protocol Identification Number
NCT04739228
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University of Rome
Collaborators
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Emotional Stress, Skin Diseases, Disclosure
Keywords
Dermatology, Guided Writing Disclosure Protocol, Psychological Distress, Positive Psychology, Randomized-controlled Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Written Disclosure Protocol Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Guided Written Disclosure Protocol Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control Group
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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
Time Frame
Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Title
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.
Description
Psychological distress will be measured with the GHQ-12 (minimum value=1; maximum value=4, with higher score indicating greater outcome).
Time Frame
Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Secondary Outcome Measure Information:
Title
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.
Description
Emotion regulation will be measured with ERQ (minimum value=1; maximum value=7), a questionnaire assessing expressive suppression and cognitive reappraisal.
Time Frame
Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Title
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.
Description
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.
Time Frame
Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Title
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.
Description
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
Time Frame
Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Iani, PhD
Organizational Affiliation
European University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
City
Rome
ZIP/Postal Code
00167
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
11906981
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.
Results Reference
result
PubMed Identifier
19742069
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.
Results Reference
result

Learn more about this trial

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

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