Clinical trial NCT03667729: 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
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorders
Psychotic Disorder
Keywords: PMR, anxiety, psychotic syndrome, quality of life
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of life simplified Chinese versions of the WHOQOL-BREF questionnaire were used
timeFrame: Measuring changes in quality of life from baseline to 6 months.
Secondary outcomes:
measure: Anxiety Scale
timeFrame: measured at baseline, 3-month, and 3-month follow-up
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: measured at baseline, 3-month, and 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: hsiu-ju Chang, PHD
role: PRINCIPAL_INVESTIGATOR
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