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

NCT04639596 | Withdrawn

• 1 other identifier: IRB_00122169
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.MBTS participants will experience greater enjoyment of the activity than SRT participants.
3. 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. 4.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

Keywords

Psychiatric Disorder; Substance Use Disorders; Sailing; Bowling

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

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.

Behavioral: Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).

Interventions

Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT). BEHAVIORAL

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.

MBTS; SRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one psychiatric or substance use disorder
• At least one Mental Health Service appointment within the previous 12 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Salt Lake City Health Care System: lead

Study Sites (1)

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Mental Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• William R Marchand, MD

  Salt Lake City Veterans' Administration Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 20, 2020
• Study Start: July 10, 2019
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)