Evaluation of Outcomes Following Surf Therapy

August 31, 2021 updated by: Kristen Walter, United States Naval Medical Center, San Diego

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Surf therapy cohort 1
The first cohort of participants to enroll in the study (i.e., participants in the first 6-week program)
Behavioral: Surf therapy
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.
Surf therapy cohort 2
The second cohort of participants to enroll in the study (i.e., participants in the second 6-week program)
Behavioral: Surf therapy
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.
Surf therapy cohort 3
The third cohort of participants to enroll in the study (i.e., participants in the third 6-week program)
Behavioral: Surf therapy
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.
Surf therapy cohort 4
The fourth cohort of participants to enroll in the study (i.e., participants in the fourth 6-week program)
Behavioral: Surf therapy
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.
Surf therapy cohort 5
The fifth cohort of participants to enroll in the study (i.e., participants in the fifth 6-week program)
Behavioral: Surf therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-8)
Time Frame: From pre- to post-program (e.g., approximately 6-8 weeks)
Self-reported depression symptoms
From pre- to post-program (e.g., approximately 6-8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: From pre- to post-program (e.g., approximately 6-8 weeks)
Report of satisfaction with the surf therapy program
From pre- to post-program (e.g., approximately 6-8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United States Naval Medical Center, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Naval Health Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Betty Michalewicz-Kragh, M.S., United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMCSD.2016.0032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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