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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive

Clinicaltrials.gov identifier NCT03928392

Recruitment Status Completed

First Posted April 26, 2019

Last update posted June 24, 2019

Study Description

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.

  • Condition or Disease:Post Traumatic Stress Disorder
    Anxiety
    Stress, Psychological
    Depression
  • Intervention/Treatment: Behavioral: SCUBA with Occupational Therapy (OT)
    Behavioral: Self-Contained Underwater Breathing Apparatus (SCUBA) without OT
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 15 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 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.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
  • Actual Study Start Date: February 2019
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: April 2019
Arms and interventions
Arm Intervention/treatment
Experimental: SCUBA Dive with OT
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)
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.
Active Comparator: SCUBA Dive without OT
The group will engage in two SCUBA dives.
Behavioral: Self-Contained Underwater Breathing Apparatus (SCUBA) without OT
Study participants will continue their regular SCUBA diving activity through the Wounded American Veterans Experience SCUBA (WAVES) program. They will complete two dives.
Outcome Measures
  • Primary Outcome Measures: 1. Satisfaction with occupational performance [ Time Frame: Change between baseline and three weeks. ]
    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.
  • Secondary Outcome Measures: 1. The PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Change between baseline and three weeks ]
    The PTSD Checklist for DSM-5 (PCL-5) assesses the 20 DSM-5 symptoms of PTSD through a 20-item self-report measure. In the PCL-5, individuals are presented with a list of problems people may have as a result of a stressful situation. Individuals are asked to indicate how much they have been bothered by this problem in the past month. Problems can be rated as "not at all, a little bit (1), moderately (2), quite a bit (3), or extremely" (4).
  • 2. The Depression Anxiety and Stress Scales (DASS) [ Time Frame: Change between baseline and three weeks ]
    The Depression Anxiety and Stress Scales (DASS) is a individualized composite measurement used to assess symptoms of depression, anxiety, and stress in community settings. The DASS-21 asks 21 questions and is comprised of three subscales: The Depression sub-scale which measures hopelessness, low self-esteem, and low positive affect; the Anxiety scale which assesses autonomic arousal, musculoskeletal symptoms, situational anxiety and subjective experience of anxious arousal; and the Stress scale which assesses tension, agitation, and negative affect. There are 21 questions and responses are provided on a 4-point Likert scale, Where 0 = Did not apply to me, 1 = applied to me some degree, or some of the time, 2 = applied to me a considerable degree or good part of time, and 3 = applied to me very much or most of the time.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 95 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 18 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

Exclusion Criteria:

- 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

Contacts and Locations
Contacts
Locations

United States, California
Loma Linda Universtiy
Loma Linda

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Dragana Krpalek, PhD Loma Linda University Health

More Information
  • Responsible Party: Loma Linda University
  • ClinicalTrials.gov Identifier: NCT03928392 History of Changes
  • Other Study ID Numbers: 5180305
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: June 24, 2019
  • Last Verified: June 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Loma Linda University: Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy
  • Additional relevant MeSH terms: Depression
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic
    Stress, Psychological