Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)
Primary Purpose
Psychiatric Disorder, Substance Use Disorders
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric Disorder focused on measuring Psychiatric Disorder, Substance Use Disorders, Sailing, Bowling
Eligibility Criteria
Inclusion Criteria:
- At least one psychiatric or substance use disorder
- At least one Mental Health Service appointment within the previous 12 months
Exclusion Criteria:
- 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.
Sites / Locations
- VA Salt Lake City Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MBTS
SRT
Arm Description
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 will occur on four separate occasions during the summer of 2019. SRT will consist of 4 hours of bowling at a community bowling alley.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04639596
First Posted
October 26, 2020
Last Updated
June 2, 2022
Sponsor
VA Salt Lake City Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT04639596
Brief Title
Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)
Official Title
A Randomized Controlled Trial of Mindfulness-based Therapeutic Sailing for Veterans With Psychiatric and/or Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19 we never started the study and didn't enroll anyone.
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Salt Lake City Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Substance Use Disorders
Keywords
Psychiatric Disorder, Substance Use Disorders, Sailing, Bowling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBTS
Arm Type
Experimental
Arm Description
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.
Arm Title
SRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the change of Acceptance and Action Questionnaire (AAQ2) measure for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of Toronto Mindfulness Scale (TMS) measure for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of Positive and Negative Affect Scale (PANAS)measure for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of State-Trait Anxiety Inventory (STAI) measure for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of psychiatric hospitalizations for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of Emergency Department (ED) visits for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
Title
Difference in the change of Physical Activity Enjoyment Scale (PACES)measure for MBTS and SRT
Description
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.
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one psychiatric or substance use disorder
At least one Mental Health Service appointment within the previous 12 months
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William R Marchand, MD
Organizational Affiliation
Salt Lake City Veterans' Administration Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Salt Lake City Health Care System
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)
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