The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

Not Applicable

Completed

• Conditions: Affective Disorders; Psychotic Disorder
• Interventions: Behavioral: progressive muscle relaxation

• Registration Number: NCT03667729
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study Start: 2014-06-30
• Primary Completion: 2015-06-29
• Study Completion: 2015-06-29
• Status Verified: 2017-06
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-10
• Last Update Submitted: 2018-09-10
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
progressive muscle relaxation	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.

Primary Outcome Measures

Name	Time	Method
Quality of life simplified Chinese versions of the WHOQOL-BREF questionnaire were used	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.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	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.
Anxiety Scale	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.