Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
ACAMP2020
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started May 2020
Shorter than P25 for not_applicable schizophrenia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedNovember 4, 2019
October 1, 2019
4 months
October 28, 2019
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
World Health Organization Quality of Life Instument. WHOQOL-BREF
Scores from 5 to 130, the higher score the worse outcome.
15 minutes
Secondary Outcomes (1)
Self-compassion scale (SCS)
15 minutes
Study Arms (3)
Mindful Self-Compassion
EXPERIMENTALProtocolized training program in mindfulness and self-compassion skills.
Cognitive Behaviour Therapy Group
ACTIVE COMPARATORA control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion.
Treatment as Usual
PLACEBO COMPARATOREs variable según las características clínicas y personales del paciente.
Interventions
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.
It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.
It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.
Eligibility Criteria
You may qualify if:
- Diagnosis of schizohrenia
You may not qualify if:
- Drug addict
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alicia Díaz Megolla
Universidad de Las Palmas de Gran Canaria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Psiquiatra Adjunto. Facultativo Especialista de Área.
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
May 1, 2020
Primary Completion
August 15, 2020
Study Completion
February 15, 2021
Last Updated
November 4, 2019
Record last verified: 2019-10