NCT06258512

Brief Summary

The goal of this clinical trial is to compare an intervention with a narrative therapy-based approach with standard care in overusers in general practice . The main question it aims to answer are: • An intervention with an approach based on narrative therapy can improve the perception of emotional support, and reduce the probability of suffering from anxiety and/or depression, the number of consultations, and the number of medications in primary care overusers. Participants will 10 individual sessions carried out over five months. The interval between sessions will be two weeks with a specific duration of fifty minutes per session.. If there is a comparison group: Researchers will compare two groups of overusers to see if reduces the number of visits to the primary care doctor.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

February 6, 2024

Last Update Submit

August 22, 2024

Conditions

Keywords

Healthcare utilisationPsychosocial determinants of healthPrimary careAffective social supportFrequent attenders

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in affective social support at 1 month, 6 months, and 18 months

    \- Health-related social support: Affective social support: between 5-14 poor social support / between 15 and 25 good social support. Confidential social support: between 6-17 no confidential social support / between 18 and 30 good social support. Total social support: between 11-32 no social support / between 33-55 social support It is a variable that values people's perception, from a person-centered approach to care: For its measurement we will use the DUKE-UNC functional social support scale. This is a questionnaire self-assessment consisting of 11 items that evaluates perceived social support using a five-point Likert scale. This scale provides three indicators: Affective social support with a range between 25 and 5, being the point of cut of 15; Confidential social support with a range between 30 and 6 points, being cut-off point of 18 and total social support with a range between 55 and 11 points, the cut-off point being 33. If the final score is below 33, the considers absence

    Before randomization and at the end of treatment at 1 month, six months and 18 months

Secondary Outcomes (3)

  • Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months

    Before randomization and at the end of treatment at 1 month, six months and 18 months

  • Change from baseline in variables related to drug exposure at 1 month, 6 months, and 18 months

    Before randomization and at the end of treatment at 1 month, six months and 18 months

  • Number of visits patient self-initiated consultations with PHC services, and totals, per year

    Before randomization and at the end of treatment at 1 month, six months and 18 months

Other Outcomes (2)

  • Sociodemographic data

    Before randomization

  • Clinical variables

    Before randomization

Study Arms (2)

Intervention with narrative approach + standard care

EXPERIMENTAL

Intervention with a narrative approach. The objectives will be: 1. Know significant moments in the personal history of the participant and her family according to her life cycle. as well as structural elements. 2. Know information regarding symptoms of non-organic origin, pain crises, personal and family resources for their management. 3. Implement a narrative technique as an alternative for the management of symptoms of non-organic origin, including the following strategies: the participant will be able to tell and retell their story, recognize situations or moments that exacerbate the pain, feel the pain and name it, externalization of the pain. problem, the problem is the problem, absolving oneself from traumatic life experiences, constructing meaning to one\'s dominant stories through the organization of the experience, to obtain a new meaning of what was experienced through the story, construction of alternative stories.

Other: Intervention with a narrative approach.

control with standard care

NO INTERVENTION

Participants randomly assigned to the control group will receive usual care from their primary care professionals.

Interventions

Health social workers will carry out a intervention with a narrative approach, through its training profile based on transversal skills, which will consist of 10 sessions carried out over five months. The interval between sessions will be of two weeks with a specific duration of fifty minutes per session. This type of intervention, with the objective of reorienting and redefining the demand or the initial problems that motivated the consultation, gives space to the patient\'s subjective complaint, as well as to locate the understanding of the discomfort and the symbolic meaning of the symptoms. That is, recognizing the physical symptoms while listening to stories of chaos to legitimize both the user and his symptoms, an encounter that allows return the user to its context without feeling rejected or judged by the health system.

Also known as: Narrative therapy
Intervention with narrative approach + standard care

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Users in the 95th percentile in the distribution of consultations face-to-face, patient self-initiated consultations with PHC services within the period of 1 year.

You may not qualify if:

  • Drug abuse or dependence, except for nicotine and tetrahydrocannabinol.
  • Comorbidity with DSM-IV-TR (American Psychiatric Association, 2000) severe mental disorders.
  • Comorbidity with ICD-10 (World Health Organization, 2008) severe cognitive disorders or sensory disabilities.
  • Major locomotor mobility limitations or terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Spain

Barcelona, Catalonia, 08029, Spain

RECRUITING

MeSH Terms

Conditions

Cumulative Trauma Disorders

Interventions

MethodsNarrative Therapy

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative TechniquesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Valentin Calvo-Rojas Phd, Social Worker

CONTACT

Calvo-Rojas Phd, Social Worker

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The interventions of the health social workers rely on listening in the clinical interview, They give space to the patient's subjective complaint, they locate the understanding of the discomfort and the symbolic meaning of the symptoms. The difficulties are focused as elements of the relationship between the professional and the user and does not refer to pharmacological treatments. Since social work identifies discomfort psychosocial as an object of study, we would like to demonstrate that, establishing locally an intervention with a narrative approach implemented in the area of primary health care with the aim of improving the perception of emotional support of users with excessive use of self-initiated consultation, we can reduce the use of medical consultations, and, most importantly, the suffering and discontent of said users who do not find an answer appropriate to your discomforts.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

October 18, 2023

Primary Completion

June 30, 2024

Study Completion

December 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations