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Energy in Balance: an intervention aimed at migrant women with medically unexplained symptoms

Energy in Balance: the cost effectiveness of an intervention aimed at migrant women with medically unexplained symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47401844
Enrollment
180
Registered
2018-07-10
Start date
2013-01-15
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically unexplained symptoms in general practice Signs and Symptoms

Interventions

The study has been conducted in Rotterdam, the second largest city of the Netherlands. In Rotterdam 37,4% of the population has a non-western background. The study has been carried out in general prac

Sponsors

Erasmus School of Health Policy and Management
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. All female patients, aged between 26 and 64 years of age that had a contact with the general practice participating in this study in the year before a reference day, depending on the date a GP was included 2. Having at least 6 contacts in the year preceding the study 3. Having been diagnosed by the GP by means of preferable 4 or more ICPC codes below 30 in the last 60 or 12 months This inclusion process was performed by the researchers, based on the information obtained from the Health Information System (HIS) of the participating practices. 4. Having a migrant background Since the HIS does not include this information, this part of the inclusion process was carried out by the participating GPs

Exclusion criteria

Exclusion criteria: 1. Patients not able to communicate in Dutch 2. Patients in treatment at a mental health or social welfare service. Again, the HIS does not include this information, therefore this part of the selection process was carried out by the participating GPs 3. All those suffering at any point in time from: 3.1. Serous psychopathology 3.2. Multiple sclerosis, Parkinson’s disease and epilepsy 3.3. Down syndrome, HIV/Aids, blindness and liver cirrhosis 4. All those who suffered in the year in which they also had 6 contacts or more with their GP: 4.1. Acute alcohol abuse, drug and medication abuse, memory and concentration disorders 4.2. Unwanted pregnancy, abortus provocatus, delivery of a death child 4.3. Anorexia, boulimia 4.4. Problems as a consequence of violence 4.5. Any form of cancer This part of the exclusion process again was performed by the researchers, based on the information obtained from the Health Information System of the participating practices. 5. Patients suffering from the following chronic diseases, because frequent consultations may be associated with such diseases: 5.1. Diabetes 5.2. Hypertension 5.3. Cardiovascular disease 5.4. Asthma 5.5. COPD 5.6. Anxiety 5.7. Depression

Design outcomes

Primary

MeasureTime frame
1. Quality of life measured by SF-12 at baseline and follow-up (14 months later) 2. Costs (medical and non-medical) measured at baseline and follow-up

Secondary

MeasureTime frame
1. Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9). It assesses the presence of depressive symptoms in the past two weeks with four response options (‘not at all’, ‘several days’, ‘more than half the days’, ‘nearly every day’) and is often used in primary care settings The PHQ-9 score ranges from 0 to 27, because each of the 9 items can be scored from 0 (‘not at all’) to 3 (‘nearly every day’) . The PHQ-9 is part of the full PHQ for assessment of mental disorders. 2. Somatic symptoms, assessed using the Patient Health Questionnaire-15. The PHQ-15 is a validated instrument for detecting somatization disorders. The PHQ-15 comprises 15 somatic symptoms derived from the full PHQ. In this study 13 of the PHQ-15 somatic symptoms are included in the somatic symptom subscale. In this subscale patients are asked to rate the severity of each symptom as ‘not bothered at all’, ‘bothered a little’ or ‘bothered a lot’. Thus, in determining the score, each individual symptom is coded as 0, 1 or 2 and the total score ranges from 0 to 26. For Turkish speaking participants we made use of an existing Turkish translation of the PHQ. 2. Loneliness, measured using the De Jong Gierveld Loneliness Scale, a validated and reliable instrument for measurement of overall, emotional and social loneliness. The 6-item scale was used in which the patients are asked to what extent the statements apply to them. The scale consists of 6 statements on a 3-points scale (yes, more or less and no). Scale scores range from 0 to 6. Higher scores indicate higher loneliness. 3. Self-esteem, measured using the Rosenberg Self-Esteem Scale, a 10-item scale in which patients are asked to rate their agreement with 5 positively and 5 negatively worded self-statements on a 4-points scale ranging from ‘strongly agree’ to ‘strongly disagree’ The total score (that ranges from 0 to 30) is calculated such that higher scores reflect higher self-

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026