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

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

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.

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.

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

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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