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Study protocol
Suicide Reduction in Schizophrenia via Exercise (SUnRISE): Study Protocol for A Multi-Site, Single-Blind, Randomized Clinical Trial of Aerobic Exercise for Suicide Risk Reduction in Individuals With Schizophrenia
David Kimhy
Icahn School of Medicine at Mount Sinai
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7735-9378
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5-10% completing suicide. At present, available pharmacological and psychotherapeutic treatments offer limited risk reduction benefits, thus there remain an urgent need to explore novel interventions that will ameliorate this risk. Aerobic exercise (AE) has been shown to improve a number of predictors of suicide risk (e.g., depressed mood, sleeping difficulties). As individuals with SZ display a highly sedentary lifestyle, AE may reduce suicide risk.
Methods: Employing a multi-site, single-blind, randomized clinical trial design, we will examine the impact of AE on risk for suicide and related variables in individuals with SZ. Participants will be randomized to one of two 12-week exercise interventions: AE or a stretching and toning (ST) control intervention. Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO2max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6- and 12-weeks of interventions.
Discussion: It is hypothesized that AE will reduce suicide risk among individuals with SZ. This study may offer support for a more efficacious treatment method for this population in addition to the pre-existing pharmacological and psychotherapeutic treatment regimens.
Trial Registration: Clinicaltrials.gov, NCT03270098. Registered September 1, 2017.
Keywords
Schizophrenia, Suicide, Exercise, Aerobic Fitness, VO2max
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CURRENT STATUS: Published
Version 1
Posted 28 Sep, 2020
Published
On 21 Oct, 2020
No community comments so far
Editorial decision: Accept
On 05 Oct, 2020
Reviewers invited
Invitations sent on 01 Oct, 2020
Reviewer #1 agreed
On 01 Oct, 2020
Review #1 received
Received 01 Oct, 2020
Editor assigned
On 30 Sep, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 30 Aug, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Suicide Reduction in Schizophrenia via Exercise (SUnRISE): Study Protocol for A Multi-Site, Single-Blind, Randomized Clinical Trial of Aerobic Exercise for Suicide Risk Reduction in Individuals With Schizophrenia
David Kimhy
Icahn School of Medicine at Mount Sinai
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7735-9378
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 1
Posted 28 Sep, 2020
Published
On 21 Oct, 2020
No community comments so far
Editorial decision: Accept
On 05 Oct, 2020
Reviewers invited
Invitations sent on 01 Oct, 2020
Reviewer #1 agreed
On 01 Oct, 2020
Review #1 received
Received 01 Oct, 2020
Editor assigned
On 30 Sep, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 30 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5-10% completing suicide. At present, available pharmacological and psychotherapeutic treatments offer limited risk reduction benefits, thus there remain an urgent need to explore novel interventions that will ameliorate this risk. Aerobic exercise (AE) has been shown to improve a number of predictors of suicide risk (e.g., depressed mood, sleeping difficulties). As individuals with SZ display a highly sedentary lifestyle, AE may reduce suicide risk.
Methods: Employing a multi-site, single-blind, randomized clinical trial design, we will examine the impact of AE on risk for suicide and related variables in individuals with SZ. Participants will be randomized to one of two 12-week exercise interventions: AE or a stretching and toning (ST) control intervention. Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO2max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6- and 12-weeks of interventions.
Discussion: It is hypothesized that AE will reduce suicide risk among individuals with SZ. This study may offer support for a more efficacious treatment method for this population in addition to the pre-existing pharmacological and psychotherapeutic treatment regimens.
Trial Registration: Clinicaltrials.gov, NCT03270098. Registered September 1, 2017.
Figure 1
Figure 2