NCT03667729

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 12, 2018

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

August 20, 2018

Last Update Submit

September 10, 2018

Conditions

Affective DisordersPsychotic Disorder

Keywords

PMR, anxiety, psychotic syndrome, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Anxiety Scale

    measured at baseline, 3-month, and 3-month follow-up

  • Positive and Negative Syndrome Scale (PANSS)

    measured at baseline, 3-month, and 3-month follow-up

Study Arms (2)

progressive muscle relaxation

EXPERIMENTAL

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.

Behavioral: progressive muscle relaxation

Control group

NO INTERVENTION

treatment-as-usual(TAU)

Interventions

progressive muscle relaxationBEHAVIORAL

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.

progressive muscle relaxation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (42)

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    BACKGROUND

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    BACKGROUND

  • Hedlund, J. L. & Vieweg, B. W. (1980) The Brief Psychiatric Rating Scale (BPRS): a comprehensive review. Journal of Operational Psychiatry, 11, 48- 65.

    BACKGROUND

  • Bernstein, D. & Borkove, c. T. (1973). Progressive relaxation training. Champaign, IL: Research Press.

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  • Overall, J.E., Gorham, D.R., 1962. The brief psychiatric rating scale. Psychol. Rep. 10, 799e812.

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    PMID: 20709459RESULT

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    PMID: 19531107RESULT

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    PMID: 23327116RESULT

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    PMID: 25182810RESULT

  • Georgiev A, Probst M, De Hert M, Genova V, Tonkova A, Vancampfort D. Acute effects of progressive muscle relaxation on state anxiety and subjective well-being in chronic Bulgarian patients with schizophrenia. Psychiatr Danub. 2012 Dec;24(4):367-72.

    PMID: 23132187RESULT

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    PMID: 23379898RESULT

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    PMID: 23123218RESULT

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    PMID: 27445463RESULT

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    PMID: 21602034RESULT

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    PMID: 28113098RESULT

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    PMID: 25152657RESULT

  • Karpov B, Joffe G, Aaltonen K, Suvisaari J, Baryshnikov I, Naatanen P, Koivisto M, Melartin T, Oksanen J, Suominen K, Heikkinen M, Paunio T, Isometsa E. Anxiety symptoms in a major mood and schizophrenia spectrum disorders. Eur Psychiatry. 2016 Sep;37:1-7. doi: 10.1016/j.eurpsy.2016.04.007. Epub 2016 Jul 21.

    PMID: 27447101RESULT

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    PMID: 26341538RESULT

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    PMID: 28456026RESULT

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    PMID: 28127915RESULT

  • Margariti M, Ploumpidis D, Economou M, Christodoulou GN, Papadimitriou GN. Quality of life in schizophrenia spectrum disorders: associations with insight and psychopathology. Psychiatry Res. 2015 Feb 28;225(3):695-701. doi: 10.1016/j.psychres.2014.11.016. Epub 2014 Nov 15.

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  • McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev. 2008;30:67-76. doi: 10.1093/epirev/mxn001. Epub 2008 May 14.

    PMID: 18480098RESULT

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    PMID: 23370274RESULT

  • Oliveira SE, Carvalho H, Esteves F. Toward an understanding of the quality of life construct: Validity and reliability of the WHOQOL-Bref in a psychiatric sample. Psychiatry Res. 2016 Oct 30;244:37-44. doi: 10.1016/j.psychres.2016.07.007. Epub 2016 Jul 8.

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  • Pallanti S, Quercioli L, Hollander E. Social anxiety in outpatients with schizophrenia: a relevant cause of disability. Am J Psychiatry. 2004 Jan;161(1):53-8. doi: 10.1176/appi.ajp.161.1.53.

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  • Pelka M, Kolling S, Ferrauti A, Meyer T, Pfeiffer M, Kellmann M. Acute effects of psychological relaxation techniques between two physical tasks. J Sports Sci. 2017 Feb;35(3):216-223. doi: 10.1080/02640414.2016.1161208. Epub 2016 Mar 21.

    PMID: 26999625RESULT

  • Rofail D, Regnault A, le Scouiller S, Berardo CG, Umbricht D, Fitzpatrick R. Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin. Qual Life Res. 2016 Jan;25(1):201-11. doi: 10.1007/s11136-015-1057-9. Epub 2015 Jul 5.

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  • Vancampfort D, Correll CU, Scheewe TW, Probst M, De Herdt A, Knapen J, De Hert M. Progressive muscle relaxation in persons with schizophrenia: a systematic review of randomized controlled trials. Clin Rehabil. 2013 Apr;27(4):291-8. doi: 10.1177/0269215512455531. Epub 2012 Jul 27.

    PMID: 22843353RESULT

  • 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 Jun;25(6):567-75. doi: 10.1177/0269215510395633. Epub 2011 Mar 14.

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  • 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. 2011;33(8):684-9. doi: 10.3109/09638288.2010.509458. Epub 2010 Aug 18.

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  • Vancampfort D, Probst M, Helvik Skjaerven L, Catalan-Matamoros D, Lundvik-Gyllensten A, Gomez-Conesa A, Ijntema R, De Hert M. Systematic review of the benefits of physical therapy within a multidisciplinary care approach for people with schizophrenia. Phys Ther. 2012 Jan;92(1):11-23. doi: 10.2522/ptj.20110218. Epub 2011 Nov 3.

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  • Vera-Garcia E, Mayoral-Cleries F, Vancampfort D, Stubbs B, Cuesta-Vargas AI. A systematic review of the benefits of physical therapy within a multidisciplinary care approach for people with schizophrenia: An update. Psychiatry Res. 2015 Oct 30;229(3):828-39. doi: 10.1016/j.psychres.2015.07.083. Epub 2015 Jul 31.

    PMID: 26254795RESULT

  • Wang FZ, Luo D, Kanb W, Wang Y. Combined intervention with education and progressive muscle relaxation on quality of life, functional disability, and positive symptoms in patients with acute schizophrenia. J Altern Complement Med. 2015 Mar;21(3):159-65. doi: 10.1089/acm.2014.0128. Epub 2015 Feb 11.

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  • The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k.

    PMID: 8560308RESULT

MeSH Terms

Conditions

Mood DisordersPsychotic DisordersAnxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • hsiu-ju Chang, PHD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The rater did not know what interventions the participants belonged to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

September 12, 2018

Study Start

June 30, 2014

Primary Completion

June 29, 2015

Study Completion

June 29, 2015

Last Updated

September 12, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share