Psychiatric DisorderNCT04639596
Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)
A study testing Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT). in people with Psychiatric Disorder and Substance Use Disorders, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial summary
This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders. The specific aims of this investigation are to determine whether: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psychiatric Disorder, Substance Use Disorders
- What is being tested?
- Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 27 Apr 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one psychiatric or substance use disorder
- At least one Mental Health Service appointment within the previous 12 months
Who cannot join
- Active psychosis
- Significant cognitive impairment and/or physical impairment that would preclude participation in the activities
- Previous participation in a therapeutic sailing intervention offered by the VA Salt Lake City Health Care System.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: A Randomized Controlled Trial of Mindfulness-based Therapeutic Sailing for Veterans With Psychiatric and/or Substance Use Disorders
This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders.
The specific aims of this investigation are to determine whether:
- MBTS will result in greater pre- to post-intervention increases in psychological flexibility and state mindfulness than a standard recreation therapy activity (SRT).
- MBTS participants will experience greater enjoyment of the activity than SRT participants.
- MBTS will result in greater pre- to post-intervention increases in positive affect and decreases in anxiety as measured as compared to the SRT participants.
- MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3-month post-intervention period.
- Conditions
- Psychiatric Disorder, Substance Use Disorders
- Being tested
- Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).
- Keywords
- Psychiatric Disorder, Substance Use Disorders, Sailing, Bowling
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).Behavioural
This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders.
| Study group | Role | What they receive |
|---|---|---|
| MBTS | Experimental | It will consist of four hours of sailing and mindfulness training at the Jordanelle Reservoir. Boats and skippers will be provided by Park City Sailing Association, a non-profit community organization. Receives: Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT). |
| SRT | Experimental | SRT will occur on four separate occasions during the summer of 2019. SRT will consist of 4 hours of bowling at a community bowling alley. Receives: Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change of Acceptance and Action Questionnaire (AAQ2) measure for MBTS and SRT
We want to determine if MBTS will result in greater pre- to post-intervention increases in psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ2), than a standard recreation therapy activity (SRT). The scale for each question of AAQ2 ranges from 1 to 7. A larger score means a worse outcome-less flexibility.
Measured: through study completion, an average of 3 years
Difference in the change of Toronto Mindfulness Scale (TMS) measure for MBTS and SRT
We want to determine if MBTS will result in greater pre- to post-intervention increases in state mindfulness, as measured by the Toronto Mindfulness Scale (TMS), than a standard recreation therapy activity (SRT). The scale for each question of TMS ranges from 0 to 4. A larger score means a better outcome-greater curiosity or decentering depending on the question.
Measured: through study completion, an average of 3 years
Difference in the change of Positive and Negative Affect Scale (PANAS)measure for MBTS and SRT
We want to determine if MBTS will result in greater pre- to post-intervention increases in positive affect, as measured by the Positive and Negative Affect Scale (PANAS), as compared to the SRT participants. The scale for each question of PANAS ranges from 1 to 5. A larger score indicates a positive or negative effect depending on the question.
Measured: through study completion, an average of 3 years
Difference in the change of State-Trait Anxiety Inventory (STAI) measure for MBTS and SRT
We want to determine if MBTS will result in greater pre- to post-intervention decreases in anxiety, as measured by the Spielberger State-Trait Anxiety Inventory (STAI), as compared to the SRT participants. The scale for each question of STAI ranges from 1 to 4. A larger score may indicate greater or smaller level of anxiety depending on a question.
Measured: through study completion, an average of 3 years
Difference in the change of psychiatric hospitalizations for MBTS and SRT
We want to determine if MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3 month post-intervention period as measured by number of psychiatric hospitalizations.
Measured: through study completion, an average of 3 years
Difference in the change of Emergency Department (ED) visits for MBTS and SRT
We want to determine if MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3 month post-intervention period as measured by number of ED visits for psychiatric reasons.
Measured: through study completion, an average of 3 years
Difference in the change of Physical Activity Enjoyment Scale (PACES)measure for MBTS and SRT
We want to determine if MBTS participants will experience greater enjoyment of the activity, as measured by the Physical Activity Enjoyment Scale (PACES), than SRT participants. The scale for each question of PACES ranges from 1 to 7. A larger score indicates a positive or negative experience with the activity depending on the question.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start10 Jul 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Why it stopped: Due to COVID-19 we never started the study and didn't enroll anyone.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William R Marchand, MD, Principal investigator, Salt Lake City Veterans' Administration Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639596
- Sponsor's protocol ID
- IRB_00122169
- Status last verified
- Jun 2022
- First submitted
- 26 Oct 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mindfulness-based Therapeutic Sailing for Veterans With Psychiatric and/or Substance Use Disorders
- ClinicalTrials.gov ID
- NCT04639596
- Acronym / sponsor ID
- IRB_00122169
- Conditions
- Psychiatric Disorder, Substance Use Disorders
- Keywords
- Psychiatric Disorder, Substance Use Disorders, Sailing, Bowling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 we never started the study and didn't enroll anyone.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 20 Nov 2020 (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.
This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders.
The specific aims of this investigation are to determine whether:
- MBTS will result in greater pre- to post-intervention increases in psychological flexibility and state mindfulness than a standard recreation therapy activity (SRT).
- MBTS participants will experience greater enjoyment of the activity than SRT participants.
- MBTS will result in greater pre- to post-intervention increases in positive affect and decreases in anxiety as measured as compared to the SRT participants.
- MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3-month post-intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBTS | Experimental | Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).It will consist of four hours of sailing and mindfulness training at the Jordanelle Reservoir. Boats and skippers will be provided by Park City Sailing Association, a non-profit community organization. |
| SRT | Experimental | Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).SRT will occur on four separate occasions during the summer of 2019. SRT will consist of 4 hours of bowling at a community bowling alley. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one psychiatric or substance use disorder
- At least one Mental Health Service appointment within the previous 12 months
Key exclusion criteria (3 listed)
- Active psychosis
- Significant cognitive impairment and/or physical impairment that would preclude participation in the activities
- Previous participation in a therapeutic sailing intervention offered by the VA Salt Lake City Health Care System.
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 |
|---|---|---|
| Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders. | Behavioural | MBTS, SRT |
Primary outcome
Difference in the change of Acceptance and Action Questionnaire (AAQ2) measure for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS will result in greater pre- to post-intervention increases in psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ2), than a standard recreation therapy activity (SRT). The scale for each question of AAQ2 ranges from 1 to 7. A larger score means a worse outcome-less flexibility.
Difference in the change of Toronto Mindfulness Scale (TMS) measure for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS will result in greater pre- to post-intervention increases in state mindfulness, as measured by the Toronto Mindfulness Scale (TMS), than a standard recreation therapy activity (SRT). The scale for each question of TMS ranges from 0 to 4. A larger score means a better outcome-greater curiosity or decentering depending on the question.
Difference in the change of Positive and Negative Affect Scale (PANAS)measure for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS will result in greater pre- to post-intervention increases in positive affect, as measured by the Positive and Negative Affect Scale (PANAS), as compared to the SRT participants. The scale for each question of PANAS ranges from 1 to 5. A larger score indicates a positive or negative effect depending on the question.
Difference in the change of State-Trait Anxiety Inventory (STAI) measure for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS will result in greater pre- to post-intervention decreases in anxiety, as measured by the Spielberger State-Trait Anxiety Inventory (STAI), as compared to the SRT participants. The scale for each question of STAI ranges from 1 to 4. A larger score may indicate greater or smaller level of anxiety depending on a question.
Difference in the change of psychiatric hospitalizations for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3 month post-intervention period as measured by number of psychiatric hospitalizations.
Difference in the change of Emergency Department (ED) visits for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3 month post-intervention period as measured by number of ED visits for psychiatric reasons.
Difference in the change of Physical Activity Enjoyment Scale (PACES)measure for MBTS and SRT
Time frame: through study completion, an average of 3 years
We want to determine if MBTS participants will experience greater enjoyment of the activity, as measured by the Physical Activity Enjoyment Scale (PACES), than SRT participants. The scale for each question of PACES ranges from 1 to 7. A larger score indicates a positive or negative experience with the activity depending on the question.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- 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.
William R Marchand, MD principal investigator
Salt Lake City Veterans' Administration Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT). in people with Psychiatric Disorder and Substance Use Disorders, run by VA Salt Lake City Health Care System at 1 site in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in the change of Acceptance and Action Questionnaire (AAQ2) measure for MBTS and SRT (time frame: through study completion, an average of 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022.