ClinicalTrials.gg
CompletedNCT07007013Updated Oct 27, 2026

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

An interventional study of Humor therapy in Medically Unexplained Symptoms, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Medically Unexplained Symptoms

Keywords

  • Medically unexplained symptoms
03

In context

Medically Unexplained Symptoms

71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.

This study's enrollment of 28 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.

Browse Medically Unexplained Symptoms studies →

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants may be included in the trial if they meet all of the following inclusion criteria:
  • 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 .
  • Signed informed consent for inclusion in the study, either by the participant or their legal representative.

Exclusion criteria

Exclusion Criteria:

  • Participants will be excluded if they meet any of the following exclusion criteria:
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    humor therapy

    All participants will receive an intervention based on humor therapy

    Other: Humor therapy

Interventions

  • OtherHumor therapy

    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

06

What researchers measure

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.

    Time frame: From baseline to 6 months after ending the intervention

07

Study locations

1 site
  • CAPI Baix A Mar (CSAPG)
    Vilanova i la Geltrú, Barcelona 08800, Spain
08

References and documents

Individual participant data

Plan to share: Yes — IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Oct 2026, 13 months.

Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 13 months is below that.

Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Nov 2025 → Oct 2026 and completion May 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2025
First posted
Jun 5, 2025
StartActual
Sep 1, 2025
Primary completionActual
Oct 2, 2026was Nov 2025
CompletionActual
Oct 2, 2026was May 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Oct 27, 2026
Primary completion
Nov 19, 2025→Oct 2, 2026
Oct 27, 2026
Study completion
May 1, 2026→Oct 2, 2026 (actual)
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Active, not recruiting→Completed
    Primary completion Nov 19, 2025→Oct 2, 2026
    Study completion May 1, 2026→Oct 2, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07007013
Lead sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Sep 1, 2025
Primary completion
Oct 2, 2026
Completion
Oct 2, 2026
Last update
Oct 27, 2026

Study contacts

Sarai Cuevas
principal investigator · CSAPG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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