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
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
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
NCT ID
NCT03667729
First Posted
August 20, 2018
Last Updated
September 10, 2018
Sponsor
Taipei Medical University
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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