Anxiety, Depression, Post Traumatic Stress Disorder, Stress, Psychological
Conditions
Keywords
Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy
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.
Interventions
BEHAVIORALSCUBA 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.
BEHAVIORALSelf-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.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Occupational Performance | 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
| Measure | Time frame | Description |
|---|---|---|
| The PTSD Checklist for DSM-5 (PCL-5) | 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). 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) | 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. The three subscales can be totaled for an overall DASS score, ranging from 0 to 63, with higher scores indicating higher levels of symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| SCUBA Dive Without OT The group will engage in two SCUBA dives.
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. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | SCUBA Dive Without OT | Total | SCUBA Dive With OT |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 15 Participants | 7 Participants |
| Age, Continuous | 40.63 years STANDARD_DEVIATION 7.67 | 42.33 years STANDARD_DEVIATION 7.76 | 44.29 years STANDARD_DEVIATION 7.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
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.
Time frame: Change between baseline and three weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCUBA Dive With OT | Satisfaction With Occupational Performance | 4.2 score on a scale | Standard Deviation 0.4 |
| SCUBA Dive Without OT | Satisfaction With Occupational Performance | 4.1 score on a scale | Standard Deviation 0.4 |
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.
Time frame: Change between baseline and three weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCUBA Dive With OT | The Depression Anxiety and Stress Scales (DASS) | 28.00 score on a scale | Standard Deviation 32.86 |
| SCUBA Dive Without OT | The Depression Anxiety and Stress Scales (DASS) | 36.12 score on a scale | Standard Deviation 25.22 |
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.
Time frame: Change between baseline and three weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCUBA Dive With OT | The PTSD Checklist for DSM-5 (PCL-5) | 21.6 score on a scale | Standard Deviation 7.3 |
| SCUBA Dive Without OT | The PTSD Checklist for DSM-5 (PCL-5) | 30.3 score on a scale | Standard Deviation 6.8 |