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
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.
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 - 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 |
Country | Name | City | State |
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Spain | Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Spain | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
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Catalan Institute of Health |
Spain,
Type | Measure | Description | Time frame | Safety issue |
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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 |
Status | Clinical Trial | Phase | |
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Completed |
NCT00042419 -
Work and Health Disparities Among Rural Women
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N/A |