Impact of an Intervention With a Narrative Approach in Overusers: A Clinical Trial

Overuse Syndrome Clinical Trial

Official title:

Impact of an Intervention With a Narrative Approach in Overusers in Primary Health Care: A Controlled and Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258512
• Other study ID #: CatalanIH
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Catalan Institute of Health
• Contact: Valentin Calvo-Rojas Phd, Social Worker
• Phone: 800-555-5555
• Email: valenticalvo.bcn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: The best treatment for the excessive use of the consultation is currently being discussed.

Hypothesis: An intervention with an approach based on narrative therapy, compared to standard care, leads to reducing psychosocial distress and reducing the number of consultations with the family doctor.

Objective: To evaluate the effectiveness of an intervention based on co-constructing a new narrative of symptoms of non-organic origin compared to usual clinical care, with respect to affective social support, the probability of suffering from anxiety and/or depression, and the use of the medical consultation.

Methodology: Pragmatic, controlled and randomized, non-masked clinical trial. Study subjects:

264 users (132 in each group, intervention and control) with excessive use of the consultation (95th percentile of the distribution of appointment-type and/or urgent visits to the medicine service). Intervention will be compared with narrative approach + standard care / standard care.

Determinations: Symptoms of anxiety and depression, social support, number of consultations, age, sex, marital status, educational level, income level, employment status.

Statistical analysis: In order to determine the discriminant capacity of the variables associated with the intervention, we will build a multiple regression model in which we will include those that were statistically significant in the bivariate analysis and those that are relevant according to the bibliography.

Expected results: The results will provide evidence on the effectiveness of said intervention.

Application and Relevance: This type of intervention would most likely reduce the pressure on medical-health professionals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria: 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

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Exclusion Criteria: 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

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Overuse Syndrome

Intervention

Other:
• Intervention with a narrative approach.
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.

Locations

Country	Name	City	State
Spain	Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Spain	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Catalan Institute of Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic data	We collected the following variables: Age, gender, civil status, educational level, monthly income, employment status, family life cycle and family structure. Employment status was categorised as being active in the workforce with paid work (employee or employer) or inactive/unemployed. Family life cycle was categorised as Stage I (couples with no children); Stage II (couples with children); Stage III (middle-aged parents: stage begins with empty nest) and Stage IV (aging family members: stage begins with spouses' retirement and ends at their deaths). Family structure was categorised as living alone (without close relatives but may share housing with other relations), nuclear family (including single-parent families) and extended family (enlarged nuclear family, including relatives).	Before randomization
Other	Clinical variables	The following symptoms and functional syndromes of interest are identified, which will be extracted from the record of the list of active problems in the computerized medical history: Musculoskeletal pain; Tiredness/asthenia; Headache/migraine/migraine; Dizziness/vertigo; Sleep disturbance/insomnia/difficulty sleeping; Palpitations/tachycardia; Fibromyalgia; Decreased appetite; Dyspnea/difficulty breathing; Irritable Colon; Abdominal pain; Chronic fatigue; Nausea/vomiting.	Before randomization
Primary	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	Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months	Goldberg Anxiety-Depression Scale. This is an 18-item self-report symptom inventory with a yes/no response format (Yes = 1, No = 0). The scores are based on responses to nine anxiety and nine depression items, asking how respondents have felt in the past month. The cut-off points of the Spanish version are =4 for anxiety and =2 for depression; higher scores are indicative of a high probability of having an anxiety or depressive disorder. This scale orients the diagnosis towards anxiety or depression, or both in mixed cases, and discriminates between the two entities while measuring their respective intensities,	Before randomization and at the end of treatment at 1 month, six months and 18 months
Secondary	Change from baseline in variables related to drug exposure at 1 month, 6 months, and 18 months	Drug exposure is analyzed through the primary care medical history prescription database. This database contains all medications dispensed by pharmacies. Medicines are classified according to the anatomical-therapeutic classification system: • Number of medications. We classified patients into five categories according to the number of different pharmaceutical specialties that the patient has been prescribed: 0; 1; 2 to 4; 5 to 9; 10 or more. • Prescription of anxiolytic and antidepressant drugs: the following therapeutic groups of interest are identified according to ATC classification: o Anxiolytics and hypnotics: N05BA Benzodiazepine derivatives; N05CD Benzodiazepine derivatives; N05CF Benzodiazepine-related drugs; N05CH Melatonin receptor agonists; N03AE01 Clonazepam (clonazepam is included given its high use as an anxiolytic and hypnotic agent) o Antidepressants: N06AB Selective serotonin reuptake inhibitors; N06AX Other antidepressants	Before randomization and at the end of treatment at 1 month, six months and 18 months
Secondary	Number of visits patient self-initiated consultations with PHC services, and totals, per year	They will be extracted from the electronic medical records	Before randomization and at the end of treatment at 1 month, six months and 18 months