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

Substance Use Disorders Clinical Trial

Official title:

A Randomized Controlled Trial of Mindfulness-based Therapeutic Sailing for Veterans With Psychiatric and/or Substance Use Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04639596
• Other study ID #: IRB_00122169
• Status: Withdrawn
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: April 27, 2021

Study information

• Verified date: June 2022
• Source: VA Salt Lake City Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	VA Salt Lake City Health Care System	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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