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Implementation and effectiveness of an Integrative Practice Protocol as an aid to common treatment in reducing symptoms of Depression for patients in primary health care

Implementation and effectiveness of an Integrative Practice Protocol as an adjuvant to usual treatment in reducing depressive symptoms for patients of primary healthcare

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4qv57kj
Enrollment
Unknown
Registered
2024-07-11
Start date
2024-03-26
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Anxiety

Interventions

This is a Quasi-Experimental Clinical Trial of the Stepped Wedge type. The study will be conducted in 5 Family Health Strategies of Primary Health Care in Barretos and in an affiliated health care uni
the group drawn for sequence 2 will receive the intervention in the third period (months 8-11) and, finally, the remaining group will receive the intervention in the fourth period (months 12-15). The
G11.427.410.698.277

Sponsors

Hospital do Câncer de Barretos/Fundação PIO XII
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: Participants between 18 and 69 years old; be part of the coverage area of ??the Primary Health Care territories managed by Social Organization Pio XII or be part of the staff or dependent on medical health care; being treated with antidepressants in a therapeutic dosage and/or undergoing individual psychotherapy for at least one month

Exclusion criteria

Exclusion criteria: Patients diagnosed with Bipolar Affective Disorder and/or psychotic disorders; patients who presented suicidal ideation with planning; patients with a history of trauma to the brain region; patients with neurocognitive disorders; patients who are using psychoactive substances in a pattern of risk and/or dependence; been recently bereaved (less than 6 months), or have symptoms of complicated grief; patients who have a score greater than 15 on the PHQ-9; patients who report frequent meditation practice in the last year

Design outcomes

Primary

MeasureTime frame
Assess the depressive symptoms score, determined from the Patient Health Questionnaire 9 (PHQ-9). It is expected to find a change in the patient's depression category (no depression, mild depression or moderate depression), according to the scale.;Evaluate the depressive symptoms score, based on the parameter established as a reliable change in symptoms, determined from the Patient Health Questionnaire 9 (PHQ-9). It is expected to find a reduction of at least 5 points in the questionnaire, after the patient's participation in the protocol.;To evaluate the score of depressive symptoms in relation to sustained recovery, determined from the Patient Health Questionnaire 9 (PHQ-9). It is expected that patients who changed the severity category of depressive symptoms will remain in this category 6 months after the start of interventions.

Secondary

MeasureTime frame
Assess the anxiety symptom score, determined from the Generalized Anxiety Scale 7 (GAD-7). It is expected to find a change in the patient's anxiety category (normal anxiety, mild and moderate anxiety), according to the scale.;Evaluate the patient's Quality of Life score, determined from the World Health Organization Quality Scale (WHOQOL-bref). It is expected to find an increase in the total scale score at the end of the protocol.;It is expected that the units that receive the protocol will make fewer referrals to the municipality's specialized mental health services. The number of referrals will be extracted from the Barretos city hall information system.

Countries

Brazil

Contacts

Public ContactCaroline Krauser

Hospital do Câncer de Barretos/Fundação PIO XII

caroline.krauser@unifesp.br+55 (017)33216600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)