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

European University of Rome

Status: Completed

Conditions: Disclosure; Emotional Stress; Skin Diseases; Psychological Distress

Treatments: Behavioral: Guided Written Disclosure Protocol Group; Behavioral: Active Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04739228

GDP_2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Guided Written Disclosure Protocol Group

Experimental group

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.

Treatment:

Behavioral: Guided Written Disclosure Protocol Group

Active Control Group

Active Comparator group

Treatment:

Behavioral: Active Control Group