Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial. (ACAMP2020)
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindful Self-Compassion Program
Cognitive Behaviour Therapy Group
Treatment as usual
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Psychosis, Quality of life, Mindfulness, Compassion, Self-compassion, Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizohrenia
Exclusion Criteria:
- Drug addict
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Mindful Self-Compassion
Cognitive Behaviour Therapy Group
Treatment as Usual
Arm Description
Protocolized training program in mindfulness and self-compassion skills.
A control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion.
Es variable según las características clínicas y personales del paciente.
Outcomes
Primary Outcome Measures
World Health Organization Quality of Life Instument. WHOQOL-BREF
Scores from 5 to 130, the higher score the worse outcome.
Secondary Outcome Measures
Self-compassion scale (SCS)
Scores from 5 to 130, the higher score the worse outcome
Full Information
NCT ID
NCT04144075
First Posted
October 28, 2019
Last Updated
October 31, 2019
Sponsor
Gutiérrez-Hernández, ME
1. Study Identification
Unique Protocol Identification Number
NCT04144075
Brief Title
Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
Acronym
ACAMP2020
Official Title
Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
August 15, 2020 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gutiérrez-Hernández, ME
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychosis, Quality of life, Mindfulness, Compassion, Self-compassion, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindful Self-Compassion
Arm Type
Experimental
Arm Description
Protocolized training program in mindfulness and self-compassion skills.
Arm Title
Cognitive Behaviour Therapy Group
Arm Type
Active Comparator
Arm Description
A control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion.
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Es variable según las características clínicas y personales del paciente.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Self-Compassion Program
Other Intervention Name(s)
CSM
Intervention Description
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
Intervention Name(s)
Cognitive Behaviour Therapy Group
Other Intervention Name(s)
CBTG
Intervention Description
It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.
Primary Outcome Measure Information:
Title
World Health Organization Quality of Life Instument. WHOQOL-BREF
Description
Scores from 5 to 130, the higher score the worse outcome.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Self-compassion scale (SCS)
Description
Scores from 5 to 130, the higher score the worse outcome
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizohrenia
Exclusion Criteria:
Drug addict
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Elena F Gutiérrez-Hernández
Phone
658024211
Email
benchara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Díaz Megolla
Organizational Affiliation
Universidad de Las Palmas de Gran Canaria
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
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