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Completed

NCT Number: NCT03302611

Trial of Surf and Hike Therapy for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Activity-based Interventions

Behavioral

Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.

Primary outcomes

  1. 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 outcomes

  1. PTSD Checklist (PCL-5)

    Time frame: 5 months

    The PCL-5 is a self-report instrument assessing PTSD symptom severity.

  2. 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.

  3. 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.

  4. 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. 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.

  6. Patient Health Questionnaire (PHQ-9)

    Time frame: 5 months

    The PHQ-9 is a self-report instrument that assesses the presence and severity

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

  • Naval Health Research Center

Registry information

Official study title

A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2017
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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