DepressionNCT02857751
Evaluation of Outcomes Following Surf Therapy
An observational study of Depression and Posttraumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The current study evaluates psychological and physical health outcomes for active-duty service members following participation in an established surf therapy program. Participants complete assessments before and after the surf therapy program, as well as brief assessments before and after each surf therapy session. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Posttraumatic Stress Disorder
- What is being tested?
- Surf therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample will consist of up to 75 active-duty service members (male or female) who are seeking surf therapy through the WII Wellness Program at NMCSD. As the study is being implemented into standard care, the current study is designed to have broad eligibility criteria.
Who may be able to join
- Active-duty military service members seeking surf therapy at NMCSD and have been medically cleared to participate
- Diagnosis of either a psychological (e.g., PTSD, depression) or physical (e.g., amputated limb; traumatic brain injury) condition that served as a reason for referral
Who cannot join
- Service members who cannot receive medical clearance to participate in the NMCSD surf therapy program
- Service members who have previously participated in the NMCSD surf therapy program
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Evaluation of Health Outcomes Following the NMCSD Surf Therapy Program
The current study evaluates psychological and physical health outcomes for active-duty service members following participation in an established surf therapy program. Participants complete assessments before and after the surf therapy program, as well as brief assessments before and after each surf therapy session.
Read the detailed description
The proposed study would evaluate whether an existing surf therapy program that is part of the Wounded, Ill, and Injured (WII) Wellness Program at Naval Medical Center San Diego (NMCSD), significantly reduces both psychological symptoms (e.g., PTSD, depression, anxiety, negative affect, lack of positive affect) and physical symptoms (e.g., pain, sleep) among active-duty service members. Psychological and physical symptoms will be assessed before beginning the surf program and at program completion. In addition, brief assessments of mood and symptoms will be completed before and after each individual surf therapy session.
- Conditions
- Depression, Posttraumatic Stress Disorder
- Being tested
- Surf therapy
- Keywords
- depression, PTSD, anxiety, surf therapy
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surf therapyBehavioural
The NMCSD surf therapy program is approximately 6 weeks in duration. Each surf therapy session lasts 2-3 hours and occurs in a group setting that can accommodate up to 20 service members per session. Each service member is paired with a surf instructor who works with him or her each week for the 6-week session. Goals are individually-tailored to the service member (based on participant's level of comfort in the water, experience with surfing, etc.) and can incorporate both physical and psychological objectives.
| Study group | Role | What they receive |
|---|---|---|
| Surf therapy cohort 1 | The first cohort of participants to enroll in the study (i.e., participants in the first 6-week program) Receives: Behavioral: Surf therapy | |
| Surf therapy cohort 2 | The second cohort of participants to enroll in the study (i.e., participants in the second 6-week program) Receives: Behavioral: Surf therapy | |
| Surf therapy cohort 3 | The third cohort of participants to enroll in the study (i.e., participants in the third 6-week program) Receives: Behavioral: Surf therapy | |
| Surf therapy cohort 4 | The fourth cohort of participants to enroll in the study (i.e., participants in the fourth 6-week program) Receives: Behavioral: Surf therapy | |
| Surf therapy cohort 5 | The fifth cohort of participants to enroll in the study (i.e., participants in the fifth 6-week program) Receives: Behavioral: Surf therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-8)
Self-reported depression symptoms
Measured: From pre- to post-program (e.g., approximately 6-8 weeks)
Secondary outcomes (1)
Client Satisfaction Questionnaire (CSQ-8)
Report of satisfaction with the surf therapy program
Measured: From pre- to post-program (e.g., approximately 6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start1 Jun 2016
- Primary completion15 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Naval Health Research Center
- Responsible party
- Principal investigator, Kristen Walter, United States Naval Medical Center, San Diego
- Investigators
- Betty Michalewicz-Kragh, M.S., Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857751
- Sponsor's protocol ID
- NMCSD.2016.0032
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2016
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Walter, K. H., Otis, N. P., Ray, T. N., Powell, A. L., Glassman, L. H., Michalewicz-Kragh, B., & Thomsen, C. J. (2019). Breaking the Surface: Psychological Outcomes among U.S. active duty service members following a surf therapy program. Psychology of Sport and Exercise. doi: 10.1016/j.psychsport.2019.101551
Otis, N. P., Walter, K. H., Glassman, L. H., Ray, T. N., Michalewicz-Kragh, B., & Thomsen, C. J. (2020). Effects of PTSD and MDD comorbidity on psychological changes during surf therapy sessions for active duty service members. Special Issue of Global Journal of Community Psychology and Practice on Surf Therapy. https://www.gjcpp.org/en/article.php?issue=36&article=210
Glassman LH, Otis NP, Michalewicz-Kragh B, Walter KH. Gender Differences in Psychological Outcomes Following Surf Therapy Sessions among U.S. Service Members. Int J Environ Res Public Health. 2021 Apr 27;18(9):4634. doi: 10.3390/ijerph18094634.
PubMed 33925447
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Health Outcomes Following the NMCSD Surf Therapy Program
- ClinicalTrials.gov ID
- NCT02857751
- Acronym / sponsor ID
- NMCSD.2016.0032
- Conditions
- Depression, Posttraumatic Stress Disorder
- Keywords
- depression, PTSD, anxiety, surf therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Naval Health Research Center
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study evaluates psychological and physical health outcomes for active-duty service members following participation in an established surf therapy program. Participants complete assessments before and after the surf therapy program, as well as brief assessments before and after each surf therapy session.
Detailed description
The proposed study would evaluate whether an existing surf therapy program that is part of the Wounded, Ill, and Injured (WII) Wellness Program at Naval Medical Center San Diego (NMCSD), significantly reduces both psychological symptoms (e.g., PTSD, depression, anxiety, negative affect, lack of positive affect) and physical symptoms (e.g., pain, sleep) among active-duty service members. Psychological and physical symptoms will be assessed before beginning the surf program and at program completion. In addition, brief assessments of mood and symptoms will be completed before and after each individual surf therapy session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Surf therapy cohort 1 | – | Behavioral: Surf therapyThe first cohort of participants to enroll in the study (i.e., participants in the first 6-week program) |
| Surf therapy cohort 2 | – | Behavioral: Surf therapyThe second cohort of participants to enroll in the study (i.e., participants in the second 6-week program) |
| Surf therapy cohort 3 | – | Behavioral: Surf therapyThe third cohort of participants to enroll in the study (i.e., participants in the third 6-week program) |
| Surf therapy cohort 4 | – | Behavioral: Surf therapyThe fourth cohort of participants to enroll in the study (i.e., participants in the fourth 6-week program) |
| Surf therapy cohort 5 | – | Behavioral: Surf therapyThe fifth cohort of participants to enroll in the study (i.e., participants in the fifth 6-week program) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will consist of up to 75 active-duty service members (male or female) who are seeking surf therapy through the WII Wellness Program at NMCSD. As the study is being implemented into standard care, the current study is designed to have broad eligibility criteria.
Key inclusion criteria (2 listed)
- Active-duty military service members seeking surf therapy at NMCSD and have been medically cleared to participate
- Diagnosis of either a psychological (e.g., PTSD, depression) or physical (e.g., amputated limb; traumatic brain injury) condition that served as a reason for referral
Key exclusion criteria (2 listed)
- Service members who cannot receive medical clearance to participate in the NMCSD surf therapy program
- Service members who have previously participated in the NMCSD surf therapy program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surf therapyThe NMCSD surf therapy program is approximately 6 weeks in duration. Each surf therapy session lasts 2-3 hours and occurs in a group setting that can accommodate up to 20 service members per session. Each service member is paired with a surf instructor who works with him or her each week for the 6-week session. Goals are individually-tailored to the service member (based on participant's level of comfort in the water, experience with surfing, etc.) and can incorporate both physical and psychological objectives. | Behavioural | Surf therapy cohort 1, Surf therapy cohort 2, Surf therapy cohort 3, Surf therapy cohort 4, Surf therapy cohort 5 |
Primary outcome
Patient Health Questionnaire (PHQ-8)
Time frame: From pre- to post-program (e.g., approximately 6-8 weeks)
Self-reported depression symptoms
1 secondary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: From pre- to post-program (e.g., approximately 6-8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Results publicationWalter, K. H., Otis, N. P., Ray, T. N., Powell, A. L., Glassman, L. H., Michalewicz-Kragh, B., & Thomsen, C. J. (2019). Breaking the Surface: Psychological Outcomes among U.S. active duty service members following a surf therapy program. Psychology of Sport and Exercise. doi: 10.1016/j.psychsport.2019.101551
- Results publicationOtis, N. P., Walter, K. H., Glassman, L. H., Ray, T. N., Michalewicz-Kragh, B., & Thomsen, C. J. (2020). Effects of PTSD and MDD comorbidity on psychological changes during surf therapy sessions for active duty service members. Special Issue of Global Journal of Community Psychology and Practice on Surf Therapy. https://www.gjcpp.org/en/article.php?issue=36&article=210
- Results publication: PubMed 33925447Glassman LH, Otis NP, Michalewicz-Kragh B, Walter KH. Gender Differences in Psychological Outcomes Following Surf Therapy Sessions among U.S. Service Members. Int J Environ Res Public Health. 2021 Apr 27;18(9):4634. doi: 10.3390/ijerph18094634.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Michalewicz-Kragh, M.S. principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Posttraumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-8) (time frame: From pre- to post-program (e.g., approximately 6-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857751, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.