Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial. (ACAMP2020)

October 31, 2019 updated by: Gutiérrez-Hernández, ME
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of schizohrenia

Exclusion Criteria:

  • Drug addict

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gutiérrez-Hernández, ME

Investigators

  • Study Director: Alicia Díaz Megolla, Universidad de Las Palmas de Gran Canaria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

August 15, 2020

Study Completion (Anticipated)

February 15, 2021

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-434-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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