Psychological DistressNCT04739228
Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial
A study testing Guided Written Disclosure Protocol Group in people with Psychological Distress and Emotional Stress, run by European University of Rome at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Emotional Stress, Skin Diseases
- What is being tested?
- Guided Written Disclosure Protocol Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years;
- Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
Rome, 00167
About this study
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.
Read the 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.
- Conditions
- Psychological Distress, Emotional Stress, Skin Diseases, Disclosure
- Being tested
- Guided Written Disclosure Protocol Group, Active Control Group
- Keywords
- Dermatology, Guided Writing Disclosure Protocol, Psychological Distress, Positive Psychology, Randomized-controlled Trial
- Medical subject headings
- Stress, Psychological, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Written Disclosure Protocol GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided Written Disclosure Protocol Group |
| Active Control Group | Active comparator | Not described Receives: Behavioral: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Emotion regulation will be measured with ERQ (minimum value=1; maximum value=7), a questionnaire assessing expressive suppression and cognitive reappraisal.
Measured: 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.
Measured: 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
Measured: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jul 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Rome
- Sponsor type
- University, hospital or other
- Collaborators
- IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
- Responsible party
- Principal investigator, Luca Iani, European University of Rome
- Investigators
- Luca Iani, PhD, Principal investigator, European University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739228
- Sponsor's protocol ID
- GDP_2016
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
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.
PubMed 11906981Mogk 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.
PubMed 19742069
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04739228
- Acronym / sponsor ID
- GDP_2016
- Conditions
- Psychological Distress, Emotional Stress, Skin Diseases, Disclosure
- Keywords
- Dermatology, Guided Writing Disclosure Protocol, Psychological Distress, Positive Psychology, Randomized-controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- European University of RomeUniversity, hospital or other
- Collaborators
- IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Written Disclosure Protocol Group | Experimental | Behavioral: Guided Written Disclosure Protocol GroupGuided 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 comparator | Behavioral: Active Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years;
- Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Written Disclosure Protocol GroupThe 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. | Behavioural | Guided Written Disclosure Protocol Group |
| Active Control GroupThe 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. | Behavioural | Active Control Group |
Primary outcome
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
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).
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Results publication: PubMed 11906981Gidron 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 publication: PubMed 19742069Mogk 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Iani, PhD principal investigator
European University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Written Disclosure Protocol Group in people with Psychological Distress and Emotional Stress, run by European University of Rome at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739228, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.