Affective DisordersNCT03667729

The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

A study testing progressive muscle relaxation in people with Affective Disorders and Psychotic Disorder, run by Taipei Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Affective Disorders, Psychotic Disorder
What is being tested?: progressive muscle relaxation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: No sites listed yet
Study dates: 30 Jun 2014to 29 Jun 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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.

Conditions: Affective Disorders, Psychotic Disorder
Being tested: progressive muscle relaxation
Keywords: PMR, anxiety, psychotic syndrome, quality of life
Medical subject headings: Mood Disorders, Psychotic Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

progressive muscle relaxationBehavioural
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.

Study groups in NCT03667729
Study group	Role	What they receive
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. Receives: Behavioral: progressive muscle relaxation
Control group	No intervention	treatment-as-usual(TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Measuring changes in quality of life from baseline to 6 months.

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 201429 Jun 2015

First posted12 Sep 2018
Study start30 Jun 2014
Primary completion29 Jun 2015
Study completion29 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for Affective DisordersStudies of the same condition, open and under way.
More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03667729
Sponsor's protocol ID: C20140205
Status last verified: Jun 2017
First submitted: 20 Aug 2018
Last updated: 12 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bernstein, D. A., & Borkovec, T. D. (1973). Progressive Relaxation Training: A Manual for the Helping Professions.
SpielBerger C. (1983). Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Psychologists Press.
Hedlund, J. L. & Vieweg, B. W. (1980) The Brief Psychiatric Rating Scale (BPRS): a comprehensive review. Journal of Operational Psychiatry, 11, 48- 65.
Bernstein, D. & Borkove, c. T. (1973). Progressive relaxation training. Champaign, IL: Research Press.
Overall, J.E., Gorham, D.R., 1962. The brief psychiatric rating scale. Psychol. Rep. 10, 799e812.
Overall, J.E., 1974. The brief psychiatric rating scale in psychopharmacology research. In: Pichot, P., Olivier-Martin, E. (Eds.), Psychological Measurements in Psychopharmacology: Modern Problems in Psychopharmacology. Karger, Basel, Switzerland, pp. 67e78.
Ben-Zeev D, Larson J, Sarratt M. A possible role for Progressive Muscle Relaxation in the treatment of persecutory ideation. Med Hypotheses. 2010 Dec;75(6):568-71. doi: 10.1016/j.mehy.2010.07.033. Epub 2010 Aug 14.
PubMed 20709459
Bebbington PE, Angermeyer M, Azorin JM, Marwaha S, Marteau F, Toumi M. Side-effects of antipsychotic medication and health-related quality of life in schizophrenia. Acta Psychiatr Scand Suppl. 2009;(438):22-8. doi: 10.1111/j.1600-0447.2008.01310.x.
PubMed 19132963
Achalia RM, Chaturvedi SK, Desai G, Rao GN, Prakash O. Prevalence and risk factors associated with tardive dyskinesia among Indian patients with schizophrenia. Asian J Psychiatr. 2014 Jun;9:31-5. doi: 10.1016/j.ajp.2013.12.010. Epub 2014 Jan 4.
PubMed 24813033
Chino B, Nemoto T, Fujii C, Mizuno M. Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia. Psychiatry Clin Neurosci. 2009 Aug;63(4):521-8. doi: 10.1111/j.1440-1819.2009.01995.x. Epub 2009 Jun 15.
PubMed 19531107
Cramer H, Lauche R, Klose P, Langhorst J, Dobos G. Yoga for schizophrenia: a systematic review and meta-analysis. BMC Psychiatry. 2013 Jan 18;13:32. doi: 10.1186/1471-244X-13-32.
PubMed 23327116
Erol A, Delibas H, Bora O, Mete L. The impact of insight on social functioning in patients with schizophrenia. Int J Soc Psychiatry. 2015 Jun;61(4):379-85. doi: 10.1177/0020764014548287. Epub 2014 Sep 1.
PubMed 25182810
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.
PubMed 23132187
Hartley S, Barrowclough C, Haddock G. Anxiety and depression in psychosis: a systematic review of associations with positive psychotic symptoms. Acta Psychiatr Scand. 2013 Nov;128(5):327-46. doi: 10.1111/acps.12080. Epub 2013 Feb 4.
PubMed 23379898
Harvey PD, Loewenstein DA, Czaja SJ. Hospitalization and psychosis: influences on the course of cognition and everyday functioning in people with schizophrenia. Neurobiol Dis. 2013 May;53:18-25. doi: 10.1016/j.nbd.2012.10.022. Epub 2012 Oct 31.
PubMed 23123218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia: Randomized Controlled Trials
ClinicalTrials.gov ID: NCT03667729
Acronym / sponsor ID: C20140205
Conditions: Affective Disorders, Psychotic Disorder
Keywords: PMR, anxiety, psychotic syndrome, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Taipei Medical UniversityUniversity, hospital or other
Study start: 30 Jun 2014 (actual)
Primary completion: 29 Jun 2015 (actual)
Study completion: 29 Jun 2015 (actual)
First posted: 12 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Design: This study applied a randomized parallel case-controlled design.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
progressive muscle relaxation	Experimental	Behavioral: progressive muscle relaxationThe 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.
Control group	No intervention	–treatment-as-usual(TAU)

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
progressive muscle relaxationintervention 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.	Behavioural	progressive muscle relaxation

Primary outcome

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.

2 secondary outcomes

Anxiety Scale
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
BackgroundBernstein, D. A., & Borkovec, T. D. (1973). Progressive Relaxation Training: A Manual for the Helping Professions.
BackgroundSpielBerger C. (1983). Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Psychologists Press.
BackgroundHedlund, J. L. & Vieweg, B. W. (1980) The Brief Psychiatric Rating Scale (BPRS): a comprehensive review. Journal of Operational Psychiatry, 11, 48- 65.
BackgroundBernstein, D. & Borkove, c. T. (1973). Progressive relaxation training. Champaign, IL: Research Press.
BackgroundOverall, J.E., Gorham, D.R., 1962. The brief psychiatric rating scale. Psychol. Rep. 10, 799e812.
BackgroundOverall, J.E., 1974. The brief psychiatric rating scale in psychopharmacology research. In: Pichot, P., Olivier-Martin, E. (Eds.), Psychological Measurements in Psychopharmacology: Modern Problems in Psychopharmacology. Karger, Basel, Switzerland, pp. 67e78.
Results publication: PubMed 20709459Ben-Zeev D, Larson J, Sarratt M. A possible role for Progressive Muscle Relaxation in the treatment of persecutory ideation. Med Hypotheses. 2010 Dec;75(6):568-71. doi: 10.1016/j.mehy.2010.07.033. Epub 2010 Aug 14.
Results publication: PubMed 19132963Bebbington PE, Angermeyer M, Azorin JM, Marwaha S, Marteau F, Toumi M. Side-effects of antipsychotic medication and health-related quality of life in schizophrenia. Acta Psychiatr Scand Suppl. 2009;(438):22-8. doi: 10.1111/j.1600-0447.2008.01310.x.
Results publication: PubMed 24813033Achalia RM, Chaturvedi SK, Desai G, Rao GN, Prakash O. Prevalence and risk factors associated with tardive dyskinesia among Indian patients with schizophrenia. Asian J Psychiatr. 2014 Jun;9:31-5. doi: 10.1016/j.ajp.2013.12.010. Epub 2014 Jan 4.
Results publication: PubMed 19531107Chino B, Nemoto T, Fujii C, Mizuno M. Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia. Psychiatry Clin Neurosci. 2009 Aug;63(4):521-8. doi: 10.1111/j.1440-1819.2009.01995.x. Epub 2009 Jun 15.
Results publication: PubMed 23327116Cramer H, Lauche R, Klose P, Langhorst J, Dobos G. Yoga for schizophrenia: a systematic review and meta-analysis. BMC Psychiatry. 2013 Jan 18;13:32. doi: 10.1186/1471-244X-13-32.
Results publication: PubMed 25182810Erol A, Delibas H, Bora O, Mete L. The impact of insight on social functioning in patients with schizophrenia. Int J Soc Psychiatry. 2015 Jun;61(4):379-85. doi: 10.1177/0020764014548287. Epub 2014 Sep 1.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

hsiu-ju Chang, PHD principal investigator

Taipei Medical University

Questions about this trial

What is this clinical trial studying?

A study testing progressive muscle relaxation in people with Affective Disorders and Psychotic Disorder, run by Taipei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667729, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.