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

Primary Purpose

Post Traumatic Stress Disorder, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCUBA with Occupational Therapy (OT)
Self-Contained Underwater Breathing Apparatus (SCUBA) without OT
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda Universtiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCUBA Dive with OT

SCUBA Dive without OT

Arm Description

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.

The group will engage in two SCUBA dives.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2019
Last Updated
January 30, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03928392
Brief Title
Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
Official Title
Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2019 (Actual)
Primary Completion Date
March 17, 2019 (Actual)
Study Completion Date
April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Depression, Anxiety, Stress, Psychological
Keywords
Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCUBA Dive with OT
Arm Type
Experimental
Arm Description
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.
Arm Title
SCUBA Dive without OT
Arm Type
Active Comparator
Arm Description
The group will engage in two SCUBA dives.
Intervention Type
Behavioral
Intervention Name(s)
SCUBA with Occupational Therapy (OT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Contained Underwater Breathing Apparatus (SCUBA) without OT
Intervention Description
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 Measure Information:
Title
Satisfaction With Occupational Performance
Description
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.
Time Frame
Change between baseline and three weeks.
Secondary Outcome Measure Information:
Title
The PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Change between baseline and three weeks
Title
The Depression Anxiety and Stress Scales (DASS)
Description
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.
Time Frame
Change between baseline and three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragana Krpalek, PhD
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Universtiy
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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