Trial of Surf and Hike Therapy for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302611
• Other study ID #: NMCSD.2017.0007
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2023
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Naval Health Research Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Rating Scale (PRS)	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
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	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	PTSD Checklist (PCL-5)	The PCL-5 is a self-report instrument assessing PTSD symptom severity.	5 months
Secondary	Generalized Anxiety Disorder (GAD-7)	The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.	5 months
Secondary	Short Form Health Survey - 36 Item, Version 2 (SF-36)	The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.	5 months
Secondary	Positive and Negative Affect scales (PANAS)	PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.	5 months
Secondary	Insomnia Severity Index (ISI)	The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.	5 months
Secondary	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a self-report instrument that assesses the presence and severity	5 months

External Links

•   Link to outcomes manuscript