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

Not Applicable

• Conditions: Schizophrenia
• Interventions: Behavioral: Mindful Self-Compassion Program; Behavioral: Cognitive Behaviour Therapy Group; Other: Treatment as usual

• Registration Number: NCT04144075
• Lead Sponsor: Gutiérrez-Hernández, ME

Brief Summary

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

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

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04
• Study Start: 2020-05-01
• Primary Completion: 2020-08-15
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis of schizohrenia

Exclusion Criteria

• Drug addict

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindful Self-Compassion	Mindful Self-Compassion Program	Protocolized training program in mindfulness and self-compassion skills.
Cognitive Behaviour Therapy Group	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.
Treatment as Usual	Treatment as usual	Es variable según las características clínicas y personales del paciente.

Primary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life Instument. WHOQOL-BREF	15 minutes	Scores from 5 to 130, the higher score the worse outcome.

Secondary Outcome Measures

Name	Time	Method
Self-compassion scale (SCS)	15 minutes	Scores from 5 to 130, the higher score the worse outcome