- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03302611
Trial of Surf and Hike Therapy for Major Depressive Disorder
March 10, 2023 updated by: Kristen Walter, United States Naval Medical Center, San Diego
A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
This study uses a randomized controlled trial design to compare the psychological effects of surf therapy to hike therapy in active duty service members who have been diagnosed with major depressive disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective, longitudinal randomized controlled trial will enroll up to 86 active duty service members with major depressive disorder who are seeking surf or hike therapy as part of their standard medical care.
Participants will be randomly assigned to receive 6 weeks of either surf or hike therapy.
Assessor-administered and self-report measures will be completed at pre- and post-program, as well as three months following program completion.
Participants also will complete brief, self-report assessments before and after each program activity session.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
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
-
-
California
-
San Diego, California, United States, 92134
- Naval Medical Center San Diego
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-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be a military service member seeking surf or hike therapy as part of the Wounded, Ill, and Injured Wellness program at Naval Medical Center San Diego;
- Have medical clearance to participate in these programs;
- Have a current diagnosis of Major Depressive Disorder based on DSM-5 criteria.
Exclusion Criteria:
- Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
- Service members who are currently pregnant
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surf Therapy
Participants receive a physical activity-based intervention, which in this arm is surf therapy.
Each service member is paired with a surf instructor who typically works with them each week for the length of the program.
|
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
|
Active Comparator: Hike Therapy
Participants receive a physical activity-based intervention, which in this arm is hike therapy.
During hike therapy, service members may hike together or at a self-selected pace.
|
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 5 months
|
The MADRS is a widely used, semi-structured, clinical-interview assessment of depression symptom severity that is intended to be sensitive to change following an intervention.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist (PCL-5)
Time Frame: 5 months
|
The PCL-5 is a self-report instrument assessing PTSD symptom severity.
|
5 months
|
Generalized Anxiety Disorder (GAD-7)
Time Frame: 5 months
|
The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.
|
5 months
|
Short Form Health Survey - 36 Item, Version 2 (SF-36)
Time Frame: 5 months
|
The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.
|
5 months
|
Positive and Negative Affect scales (PANAS)
Time Frame: 5 months
|
PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.
|
5 months
|
Insomnia Severity Index (ISI)
Time Frame: 5 months
|
The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.
|
5 months
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 5 months
|
The PHQ-9 is a self-report instrument that assesses the presence and severity
|
5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Rating Scale (PRS)
Time Frame: 5 months
|
The PRS is a self-report measure that assesses current level of pain.
It consists of one item rated on an 11-point scale from 0 (no pain) to 10 (worst possible pain).
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Walter KH, Otis NP, Glassman LH, Ray TN, Michalewicz-Kragh B, Kobayashi Elliott KT, Thomsen CJ. Comparison of surf and hike therapy for active duty service members with major depressive disorder: Study protocol for a randomized controlled trial of novel interventions in a naturalistic setting. Contemp Clin Trials Commun. 2019 Aug 21;16:100435. doi: 10.1016/j.conctc.2019.100435. eCollection 2019 Dec.
- Walter KH, Otis NP, Ray TN, Glassman LH, Beltran JL, Kobayashi Elliott KT, Michalewicz-Kragh B. A randomized controlled trial of surf and hike therapy for U.S. active duty service members with major depressive disorder. BMC Psychiatry. 2023 Feb 17;23(1):109. doi: 10.1186/s12888-022-04452-7.
Helpful Links
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)
January 1, 2018
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
October 2, 2017
First Submitted That Met QC Criteria
October 4, 2017
First Posted (Actual)
October 5, 2017
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2017.0007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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