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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928392
Other study ID # 5180305
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2019
Est. completion date April 23, 2019

Study information

Verified date January 2023
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date April 23, 2019
Est. primary completion date March 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Loma Linda Universtiy Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The PTSD Checklist for DSM-5 (PCL-5) 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). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores reflect more PTSD symptoms. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples. Change between baseline and three weeks
Secondary The Depression Anxiety and Stress Scales (DASS) 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. The three subscales can be totaled for an overall DASS score, ranging from 0 to 63, with higher scores indicating higher levels of symptoms. Change between baseline and three weeks
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