Impact of an Intervention with a Narrative Approach in Overusers: a Clinical Trial
1 other identifier
interventional
264
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 26, 2024
August 1, 2024
9 months
February 6, 2024
August 22, 2024
Conditions
Keywords
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
EXPERIMENTALIntervention 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.
control with standard care
NO INTERVENTIONParticipants 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.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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