Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.

NCT ID: NCT04144075

Last Updated: 2019-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

MAIN AIM To check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme, compared with those participating in an active control programme or those following usual treatment.

DESIGN

Randomized clinical trial, three parallel groups:

1. Experimental, which will receive the MSC together with the usual treatment (TAU).
2. Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU.
3. Passive control, which will receive the TAU. STUDY DISORDER

Schizophrenia. DATA FROM THE INTERVENTION UNDER STUDY Program developed by Kristin Neff and Christopher Germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables.

POPULATION UNDER STUDY Patients from Telde's Mental Health Unit who have been diagnosed with schizophrenia.

TOTAL NUMBER OF SUBJECTS 150

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindful Self-Compassion

Protocolized training program in mindfulness and self-compassion skills.

Group Type EXPERIMENTAL

Mindful Self-Compassion Program

Intervention Type BEHAVIORAL

It is a protocolized training program in mindfulness and self-compassion skills. It has a duration of 8 weekly group sessions of about two hours and 45 minutes and a silent retreat of 4 hours.

Cognitive Behaviour Therapy Group

A control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion.

Group Type ACTIVE_COMPARATOR

Cognitive Behaviour Therapy Group

Intervention Type BEHAVIORAL

It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.

Treatment as Usual

Es variable según las características clínicas y personales del paciente.

Group Type PLACEBO_COMPARATOR

Treatment as usual

Intervention Type OTHER

It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindful Self-Compassion Program

It is a protocolized training program in mindfulness and self-compassion skills. It has a duration of 8 weekly group sessions of about two hours and 45 minutes and a silent retreat of 4 hours.

Intervention Type BEHAVIORAL

Cognitive Behaviour Therapy Group

It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.

Intervention Type BEHAVIORAL

Treatment as usual

It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CSM CBTG TAU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of schizohrenia

Exclusion Criteria

* Drug addict
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gutiérrez-Hernández, ME

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gutiérrez-Hernández, ME

Psiquiatra Adjunto. Facultativo Especialista de Área.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alicia Díaz Megolla

Role: STUDY_DIRECTOR

Universidad de Las Palmas de Gran Canaria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

María Elena F Gutiérrez-Hernández

Role: CONTACT

658024211

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-434-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.