Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental Study

NCT07007013 | Active Not Recruiting

• 1 other identifier: CSAPG-75
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to study the effectiveness of the intervention for medically unexplained symptoms(MUS) in terms of changes in emotional well-being before and after the intervention (humor therapy)

Conditions

Medically Unexplained Symptoms

Keywords

Medically unexplained symptoms

Outcome Measures

Primary Outcomes (1)

• emotional well-being

  Emotional well-being will be measured before-after intervention through the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Range scale: 14-70. Higher scores indicate greater well-being.

  From baseline to 6 months after ending the intervention

Study Arms (1)

humor therapy

EXPERIMENTAL

All participants will receive an intervention based on humor therapy

Other: Humor therapy

Interventions

Humor therapy OTHER

The intervention consists of a cycle of 8 group sessions (one per week) led by trained professionals specialized in humor ('clown doctors'). Each session will last approximately 90 to 120 minutes

humor therapy

Eligibility Criteria

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

You may qualify if:

• Men and women over 18 years of age.
• Diagnosed with the condition under study (see Section 2: Definitions).
• Expected to undergo follow-up for their condition at the study center.
• Ability to participate in the required assessments.
• Legal capacity to provide informed consent.

You may not qualify if:

• Participants diagnosed with any of the following conditions:
• Severe mental health disorder, as determined by the investigator
• Cognitive impairment of any etiology, as recorded in the medical history
• Treatment for the condition under study using community-based resources prescribed in Primary Care within the past 6 months.
• Cognitive or affective disorders that limit the ability to comply with study procedures.
• Participation in another study involving an experimental intervention during the period of the present trial and/or requiring visit schedules that are incompatible with this trial.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

CAPI Baix A Mar (CSAPG)

Vilanova i la Geltrú, Barcelona, 08800, Spain

Location

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarai Cuevas

  CSAPG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: September 1, 2025
• Primary Completion: November 19, 2025
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)