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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04144075
Other study ID # 2019-434-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date February 15, 2021

Study information

Verified date October 2019
Source Complejo Hospitalario Universitario Insular Materno Infantil
Contact María Elena F Gutiérrez-Hernández
Phone 658024211
Email benchara@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date February 15, 2021
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosis of schizohrenia

Exclusion Criteria:

- Drug addict

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Cognitive Behaviour Therapy Group
It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.
Other:
Treatment as usual
It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gutiérrez-Hernández, ME

Outcome

Type Measure Description Time frame Safety issue
Primary World Health Organization Quality of Life Instument. WHOQOL-BREF Scores from 5 to 130, the higher score the worse outcome. 15 minutes
Secondary Self-compassion scale (SCS) Scores from 5 to 130, the higher score the worse outcome 15 minutes
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