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

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ClinicalTrials.gov Identifier: NCT03928392
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dragana Krpalek, Loma Linda University

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 Intervention/treatment Phase
Post Traumatic Stress Disorder Depression Anxiety Stress, Psychological Behavioral: SCUBA with Occupational Therapy (OT) Behavioral: Self-Contained Underwater Breathing Apparatus (SCUBA) without OT Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 3, 2019
Actual Primary Completion Date : March 17, 2019
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928392


Locations
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United States, California
Loma Linda Universtiy
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Dragana Krpalek, PhD Loma Linda University Health

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Responsible Party: Dragana Krpalek, Assistant Professor, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dragana Krpalek, Loma Linda University:
Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy

Additional relevant MeSH terms:
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Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress, Psychological
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders