Trial of Surf and Hike Therapy for Major Depressive Disorder

Overview

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.

Full Title of Study: “A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2020

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.

Interventions

  • Behavioral: Physical Activity-based Interventions
    • Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • PTSD Checklist (PCL-5)
    • Time Frame: 5 months
    • The PCL-5 is a self-report instrument assessing PTSD symptom severity.
  • 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.
  • 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.
  • 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.
  • 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.
  • Patient Health Questionnaire (PHQ-9)
    • Time Frame: 5 months
    • The PHQ-9 is a self-report instrument that assesses the presence and severity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • United States Naval Medical Center, San Diego
  • Collaborator
    • Naval Health Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cynthia J. Thomsen, Ph.D., Principal Investigator, Naval Health Research Center
  • Overall Contact(s)
    • Betty Michalewicz-Kragh, M.S., 619-532-7727, betty.michalewiczkragh.civ@mail.mil

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