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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03667729
Other study ID # C20140205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2014
Est. completion date June 29, 2015

Study information

Verified date June 2017
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date June 29, 2015
Est. primary completion date June 29, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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


Intervention

Behavioral:
progressive muscle relaxation
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

References & Publications (42)

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Vancampfort D, De Hert M, Knapen J, Maurissen K, Raepsaet J, Deckx S, Remans S, Probst M. Effects of progressive muscle relaxation on state anxiety and subjective well-being in people with schizophrenia: a randomized controlled trial. Clin Rehabil. 2011 J — View Citation

Vancampfort D, De Hert M, Knapen J, Wampers M, Demunter H, Deckx S, Maurissen K, Probst M. State anxiety, psychological stress and positive well-being responses to yoga and aerobic exercise in people with schizophrenia: a pilot study. Disabil Rehabil. 201 — View Citation

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* Note: There are 42 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measuring changes in quality of life from baseline to 6 months.
Secondary 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. measured at baseline, 3-month, and 3-month follow-up
Secondary 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. measured at baseline, 3-month, and 3-month follow-up
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