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Randomized controlled clinical trial evaluating a complementary Spiritual Intervention adjunctive to conventional psychiatric inpatient treatment

Effectiveness of a complementary Spiritual Intervention to conventional psychiatric treatment in hospitalized patients with suicidal behavior: an observational intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-82fjc5f
Enrollment
Unknown
Registered
2025-10-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Feeding and Eating Disorders

Interventions

This is a double-blinded, parallel, randomized, controlled clinical trial conducted with two groups. Participants will be randomized and allocated in a 1:1 ratio to one of the two groups. Block random

Sponsors

Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients admitted to a psychiatric inpatient unit

Exclusion criteria

Exclusion criteria: Significant cognitive disorganization that prevents the participant from understanding and adequately responding to the questionnaires used for data collection

Design outcomes

Primary

MeasureTime frame
A greater reduction in mental symptoms from baseline to the end of hospitalization is expected in the experimental group compared to the control group, as measured by the BPRS (Brief Psychiatric Rating Scale) and CGI (Clinical Global Impression) scale, when controlled for sex, age, and educational level.

Secondary

MeasureTime frame
A greater reduction from baseline to the end of hospitalization in suicidal ideation and depressive symptoms is expected in the experimental group compared to the control group, as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale) and HAM-D (Hamilton Depression Rating Scale), respectively, while controlling for sex, age, and educational level. ;It is expected that the specific items provided during the mediumistic meeting will coincide with the patient’s data collected in their clinical history.;It is expected that the team’s assessment of the need for the patient’s participation in the spiritual intervention, the outcome of the mediumistic meeting as reported by the medium team, the patient’s primary psychiatric diagnosis, and the patient’s level of religiosity will be independent predictors of clinical improvement in the experimental group at the end of the study, as measured by the BPRS (Brief Psychiatric Rating Scale) and CGI (Clinical Global Impression) scales.;A greater increase from baseline to the end of hospitalization in quality of life, reasons for living, and spirituality is expected in the experimental group compared to the control group, as measured by the WHOQOL-Bref (World Health Organization Quality of Life – Brief Version), RLI (Reasons for Living Inventory), and WHOQOL-SRPB (World Health Organization Quality of Life – Spirituality, Religiosity, and Personal Beliefs) scales, respectively, while controlling for sex, age, and educational level.

Countries

Brazil

Contacts

Public ContactHomero Vallada

Faculdade de Medicina da Universidade de São Paulo

hvallada@usp.br+55 (11) 2661 - 0000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)