Overuse SyndromeNCT06258512
Impact of an Intervention with a Narrative Approach in Overusers: a Clinical Trial
A study testing Intervention with a narrative approach. in people with Overuse Syndrome, run by Catalan Institute of Health at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Overuse Syndrome
- What is being tested?
- Intervention with a narrative approach.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Spain
Barcelona, Catalonia, 08029
Valentin Calvo-Rojas Phd, 800-555-5555, valenticalvo.bcn.ics@gencat.cat
Calvo-Rojas Phd, Social Worker, 800-555-5555, valenticalvo.bcn.ics@gencat.cat
About this study
Official title: Impact of an Intervention with a Narrative Approach in Overusers in Primary Health Care: a Controlled and Randomized Trial
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.
Read more
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.
Read the detailed 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.
- Conditions
- Overuse Syndrome
- Being tested
- Intervention with a narrative approach.
- Keywords
- Healthcare utilisation, Psychosocial determinants of health, Primary care, Affective social support, Frequent attenders
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with a narrative approach.Other
Also called Narrative therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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,
Measured: 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
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
Measured: 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
They will be extracted from the electronic medical records
Measured: Before randomization and at the end of treatment at 1 month, six months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start18 Oct 2023
- Primary completion30 Jun 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overuse SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalan Institute of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valentin Calvo Rojas, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258512
- Sponsor's protocol ID
- CatalanIH
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intervention with a Narrative Approach in Overusers in Primary Health Care: a Controlled and Randomized Trial
- ClinicalTrials.gov ID
- NCT06258512
- Acronym / sponsor ID
- CatalanIH
- Conditions
- Overuse Syndrome
- Keywords
- Healthcare utilisation, Psychosocial determinants of health, Primary care, Affective social support, Frequent attenders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Catalan Institute of HealthOther government
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention with narrative approach + standard care | Experimental | Other: Intervention with a narrative approach.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. |
| control with standard care | No intervention | –Participants randomly assigned to the control group will receive usual care from their primary care professionals. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with a narrative approach.Also: Narrative therapyHealth 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. | Other | Intervention with narrative approach + standard care |
Primary outcome
Change from baseline in affective social support at 1 month, 6 months, and 18 months
Time frame: Before randomization and at the end of treatment at 1 month, six 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
3 secondary outcomes
Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months
Time frame: 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
Time frame: 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
Time frame: Before randomization and at the end of treatment at 1 month, six months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with a narrative approach. in people with Overuse Syndrome, run by Catalan Institute of Health at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentin Calvo-Rojas Phd, Social Worker (800-555-5555, valenticalvo.bcn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in affective social support at 1 month, 6 months, and 18 months (time frame: Before randomization and at the end of treatment at 1 month, six months and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.