The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

September 10, 2018 updated by: Taipei Medical University

The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia: Randomized Controlled Trials

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: progressive muscle relaxation
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.
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.
No Intervention: Control group
treatment-as-usual(TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life simplified Chinese versions of the WHOQOL-BREF questionnaire were used
Time Frame: Measuring changes in quality of life from baseline to 6 months.
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.
Measuring changes in quality of life from baseline to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Scale
Time Frame: measured at baseline, 3-month, and 3-month follow-up
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.
measured at baseline, 3-month, and 3-month follow-up
Positive and Negative Syndrome Scale (PANSS)
Time Frame: measured at baseline, 3-month, and 3-month follow-up
The instrument was developed by Kay et al. (1987) to assess psychopathology of schizophrenia which includes: positive, negative, general psychopathology symptoms.
measured at baseline, 3-month, and 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: hsiu-ju Chang, PHD, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2014

Primary Completion (Actual)

June 29, 2015

Study Completion (Actual)

June 29, 2015

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Affective Disorders

Clinical Trials on progressive muscle relaxation

3
Subscribe