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The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

Primary Purpose

Affective Disorders, Psychotic Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
progressive muscle relaxation
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Affective Disorders focused on measuring PMR, anxiety, psychotic syndrome, quality of life

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of Schizophrenia
  • Without the risk of self-injury and violence
  • Patients aged from 20-65 years old
  • Had no alcohol and drug abuse
  • Can use Mandarin or Taiwanese to communicate

Exclusion Criteria:

  • Patients with another psychiatric comorbidity
  • Patients with musculoskeletal problems
  • patients who cannot sit last for 50 minutes
  • Had received progressive muscle relaxation training within the last year
  • Diagnosis of confirmed cardiovascular disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    progressive muscle relaxation

    Control group

    Arm Description

    The experimental group received PMR once a week for a total of 12 weeks. Subjects completed measures at baseline, 3-month, and 3-month follow-up.

    treatment-as-usual(TAU)

    Outcomes

    Primary Outcome Measures

    Quality of life simplified Chinese versions of the WHOQOL-BREF questionnaire were used
    a 28-item questionnaire rated on a five-point Likert scale with four domains measuring: psychological health, physical health, social relationships and environment.so that higher scores refer to high QOL.

    Secondary Outcome Measures

    Anxiety Scale
    State anxiety was assessed by the State anxiety inventory (SAI) of Spielberg (1984). The range of possible total scores is 20-80. Higher scores indicate higher levels of anxiety.
    Positive and Negative Syndrome Scale (PANSS)
    The instrument was developed by Kay et al. (1987) to assess psychopathology of schizophrenia which includes: positive, negative, general psychopathology symptoms.

    Full Information

    First Posted
    August 20, 2018
    Last Updated
    September 10, 2018
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03667729
    Brief Title
    The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia
    Official Title
    The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia: Randomized Controlled Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2014 (Actual)
    Primary Completion Date
    June 29, 2015 (Actual)
    Study Completion Date
    June 29, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study applied a randomized parallel case-controlled design. The study purpose was to evaluate the effects of progressive muscle relaxation on anxiety, psychiatric symptoms and quality of life among patients with chronic schizophrenia compared with an active control.
    Detailed Description
    Background: Anti-psychotic drugs are limited in their ability to improve psychiatric symptoms, quality of life, and anxiety status in patients with chronic schizophrenia. Progressive Muscle Relaxation (PMR) can potentially reduce anxiety status and improve subjective welling in acute patients. It is an ideal rehabilitation intervention for patients with chronic schizophrenia. However, no study has investigated the effects of PMR on outcomes among patients with chronic schizophrenia. Design: This study applied a randomized parallel case-controlled design. Methods: Hospital-based randomized control trial in Taiwan. Eighty subjects with chronic schizophrenia were recruited from a psychotic ward and randomized into PMR, or control groups. Patients in the intervention group participated in progressive muscle relaxation for 12 weeks; while patients in the control group members received supportive treatment-as-usual (TAU). All participants completed anxiety, psychotic syndromes and quality of life measures at baseline, 3-month, and 3-month follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Affective Disorders, Psychotic Disorder
    Keywords
    PMR, anxiety, psychotic syndrome, quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study applied a randomized parallel case-controlled design. Hospital-based randomized control trial . Subjects were chronic schizophrenia who were recruited from a psychotic ward complex and randomized into PMR, or control groups.
    Masking
    Outcomes Assessor
    Masking Description
    The rater did not know what interventions the participants belonged to.
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    progressive muscle relaxation
    Arm Type
    Experimental
    Arm Description
    The experimental group received PMR once a week for a total of 12 weeks. Subjects completed measures at baseline, 3-month, and 3-month follow-up.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    treatment-as-usual(TAU)
    Intervention Type
    Behavioral
    Intervention Name(s)
    progressive muscle relaxation
    Intervention Description
    intervention group: The experimental group received muscle relaxation training once a week for 3 consecutive months. The results were measured and followed up after 3 months.
    Primary Outcome Measure Information:
    Title
    Quality of life simplified Chinese versions of the WHOQOL-BREF questionnaire were used
    Description
    a 28-item questionnaire rated on a five-point Likert scale with four domains measuring: psychological health, physical health, social relationships and environment.so that higher scores refer to high QOL.
    Time Frame
    Measuring changes in quality of life from baseline to 6 months.
    Secondary Outcome Measure Information:
    Title
    Anxiety Scale
    Description
    State anxiety was assessed by the State anxiety inventory (SAI) of Spielberg (1984). The range of possible total scores is 20-80. Higher scores indicate higher levels of anxiety.
    Time Frame
    measured at baseline, 3-month, and 3-month follow-up
    Title
    Positive and Negative Syndrome Scale (PANSS)
    Description
    The instrument was developed by Kay et al. (1987) to assess psychopathology of schizophrenia which includes: positive, negative, general psychopathology symptoms.
    Time Frame
    measured at baseline, 3-month, and 3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Schizophrenia Without the risk of self-injury and violence Patients aged from 20-65 years old Had no alcohol and drug abuse Can use Mandarin or Taiwanese to communicate Exclusion Criteria: Patients with another psychiatric comorbidity Patients with musculoskeletal problems patients who cannot sit last for 50 minutes Had received progressive muscle relaxation training within the last year Diagnosis of confirmed cardiovascular disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hsiu-ju Chang, PHD
    Organizational Affiliation
    Taipei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

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