Clinical trial NCT04639596: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychiatric Disorder
Substance Use Disorders
Keywords: Psychiatric Disorder
Substance Use Disorders
Sailing
Bowling
Lead sponsor: VA Salt Lake City Health Care System
Sponsor class: FED
First posted: 2020-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


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.

Primary outcomes:
measure: Difference in the change of Acceptance and Action Questionnaire (AAQ2) measure for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of Toronto Mindfulness Scale (TMS) measure for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of Positive and Negative Affect Scale (PANAS)measure for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of State-Trait Anxiety Inventory (STAI) measure for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of psychiatric hospitalizations for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of Emergency Department (ED) visits for MBTS and SRT
timeFrame: through study completion, an average of 3 years
measure: Difference in the change of Physical Activity Enjoyment Scale (PACES)measure for MBTS and SRT
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: Salt Lake City Veterans' Administration Medical Center
name: William R Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References: