NCT03928392

Brief Summary

The purpose of the study is to investigate whether an occupational therapy program could enhance mental health outcomes for veterans who SCUBA dive. SCUBA diving requires modified breathing techniques and has been found to provide calming effects to individuals who engage in this activity. Occupational therapy interventions such as mindfulness, journaling, and deep breathing techniques can also provide similar calming effects. Therefore, this study will explore whether occupational therapy can provide additional benefits to overall mental health of veterans who SCUBA dive.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 1, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

April 24, 2019

Results QC Date

February 14, 2022

Last Update Submit

January 30, 2023

Conditions

Keywords

Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy

Outcome Measures

Primary Outcomes (1)

  • Satisfaction With Occupational Performance

    Study participants will complete the assessment, Canadian Occupational Performance Measure (COPM) which is an individualized composite measurement of factors designed to assess clients' perception of their occupational performance and satisfaction with that performance. The participants will identify up to 5 goals. For each goal the participant will rate their perceived performance on a scale of 1 to 10, with 1 representing the lowest level of performance and 10 representing the highest level of performance. The average of the scores will be recorded. Participants will also rate their satisfaction with performance on a scale of 1 to 10, with 1 representing the lowest level of satisfaction and 10 representing the highest level of satisfaction. The average of these scores will represent the satisfaction with performance score.

    Change between baseline and three weeks.

Secondary Outcomes (2)

  • The PTSD Checklist for DSM-5 (PCL-5)

    Change between baseline and three weeks

  • The Depression Anxiety and Stress Scales (DASS)

    Change between baseline and three weeks

Study Arms (2)

SCUBA Dive with OT

EXPERIMENTAL

Two SCUBA dives in conjunction with occupational therapy intervention. The occupational therapy intervention will take place on the beach or on the boat before/after the SCUBA dive. The intervention will consist of learning 3 different breathing techniques. Participants will also be educated about mindfulness principals. Additionally, participants will complete journaling activities between dives.

Behavioral: SCUBA with Occupational Therapy (OT)

SCUBA Dive without OT

ACTIVE COMPARATOR

The group will engage in two SCUBA dives.

Behavioral: Self-Contained Underwater Breathing Apparatus (SCUBA) without OT

Interventions

Study participants will complete two OT sessions in conjunction to their regular SCUBA diving activity. OT intervention includes breathing techniques, mindfulness strategies and a journal activity.

SCUBA Dive with OT

Study participants will continue their regular SCUBA diving activity through the Wounded American Veterans Experience SCUBA (WAVES) program. They will complete two dives.

SCUBA Dive without OT

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 95 years of age
  • Participation in WAVES Project for at least 3 months
  • Completion of 3 open water dives
  • Proficient in written and verbal English

You may not qualify if:

  • Younger than 18 years of age or older than 95 years of age
  • Not a member of WAVES Project within 3 months of study recruitment
  • Has not completed 3 open water dives
  • Not proficient in written and verbal English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda Universtiy

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersStress, Psychological

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
Dr. Dragana Krpalek
Organization
Loma Linda University

Study Officials

  • Dragana Krpalek, PhD

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two groups for this study. Both groups will engage in two SCUBA dives. Additionally one group will receive occupational therapy and the other will not. The occupational therapy sessions will occur in conjunction with the SCUBA dive.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

February 3, 2019

Primary Completion

March 17, 2019

Study Completion

April 23, 2019

Last Updated

February 1, 2023

Results First Posted

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations