Trial of Surf and Hike Therapy for Major Depressive Disorder

Sponsor

United States Naval Medical Center, San Diego (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT03302611

Collaborator

Naval Health Research Center (U.S. Fed)

110

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: Physical Activity-based Interventions	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Consenting active duty service members with major depressive disorder will be randomized to receive 6 weeks of either surf or hike therapy. Participants will be allowed to receive the other intervention (i.e., the condition that they were not originally randomized to) if interested after the initial intervention period.Consenting active duty service members with major depressive disorder will be randomized to receive 6 weeks of either surf or hike therapy. Participants will be allowed to receive the other intervention (i.e., the condition that they were not originally randomized to) if interested after the initial intervention period.

Masking:

Single (Outcomes Assessor)

Masking Description:

The assessor will be blinded to participants' intervention condition.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

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

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.

Behavioral: Physical Activity-based Interventions

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.

Behavioral: Physical Activity-based Interventions

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

Outcome Measures

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS) [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 Outcome Measures

PTSD Checklist (PCL-5) [5 months]
The PCL-5 is a self-report instrument assessing PTSD symptom severity.
Generalized Anxiety Disorder (GAD-7) [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) [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) [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) [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) [5 months]
The PHQ-9 is a self-report instrument that assesses the presence and severity

Other Outcome Measures

Pain Rating Scale (PRS) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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