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

Study Overview
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Brief Summary
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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
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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: Experimental, which will receive the MSC together with the usual treatment (TAU). Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU. 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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Mindful Self-Compassion Program
* Behavioral: Cognitive Behaviour Therapy Group
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizohrenia Exclusion Criteria: Drug addict

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Self-Compassion<br>Protocolized training program in mindfulness and self-compassion skills. | Behavioral: Mindful Self-Compassion Program<br>* 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.<br>* Other names: CSM;|
| Active Comparator: Cognitive Behaviour Therapy Group<br>A control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion. | Behavioral: Cognitive Behaviour Therapy Group<br>* It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.<br>* Other names: CBTG;|
| Placebo Comparator: Treatment as Usual<br>Es variable según las características clínicas y personales del paciente. | Other: Treatment as usual<br>* It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life Instument. WHOQOL-BREF | Scores from 5 to 130, the higher score the worse outcome. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-compassion scale (SCS) | Scores from 5 to 130, the higher score the worse outcome | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Quality of life, Mindfulness, Compassion, Self-compassion, Schizophrenia