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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
Gutiérrez-Hernández, ME
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 28, 2019
    Last Updated
    October 31, 2019
    Sponsor
    Gutiérrez-Hernández, ME
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    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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