Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)

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:

1. MBTS will result in greater pre- to post-intervention increases in psychological flexibility and state mindfulness than a standard recreation therapy activity (SRT).
2. MBTS participants will experience greater enjoyment of the activity than SRT participants.
3. 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.
4. MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3-month post-intervention period.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorders; Psychiatric Disorder
• Intervention / Treatment: Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • VA Salt Lake City Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBTS; 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: VA Salt Lake City Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): April 27, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Substance Use Disorders; Psychiatric Disorder; Sailing; Bowling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Problem Behavior; Mental Disorders
• Other Study ID Numbers: IRB_00122169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No