Clinical trial NCT03302611: Trial of Surf and Hike Therapy for Major Depressive Disorder
Official title: A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: major depressive disorder
military
surf therapy
hike therapy
randomized controlled trial
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Naval Health Research Center
First posted: 2017-10-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 5 months
Secondary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: 5 months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 5 months
measure: Short Form Health Survey - 36 Item, Version 2 (SF-36)
timeFrame: 5 months
measure: Positive and Negative Affect scales (PANAS)
timeFrame: 5 months
measure: Insomnia Severity Index (ISI)
timeFrame: 5 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 5 months
Other outcomes:
measure: Pain Rating Scale (PRS)
timeFrame: 5 months
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Naval Health Research Center
name: Cynthia J. Thomsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):109. doi: 10.1186/s12888-022-04452-7.
citation: Otis NP, Walter KH, Glassman LH, Ray TN, Kobayashi Elliott KT, Michalewicz-Kragh B. Comorbidity of depression and posttraumatic stress disorder: Outcomes from a randomized controlled trial of surf and hike therapies among service members. Psychol Trauma. 2024 Dec;16(Suppl 3):S688-S697. doi: 10.1037/tra0001673. Epub 2024 Jul 8.
citation: Glassman LH, Otis NP, Kobayashi Elliott KT, Michalewicz-Kragh B, Walter KH. Gender Differences in Psychological Outcomes Following Surf versus Hike Therapy among U.S. Service Members. Int J Environ Res Public Health. 2024 Feb 19;21(2):241. doi: 10.3390/ijerph21020241.
citation: Walter KH, Otis NP, Miggantz EL, Ray TN, Glassman LH, Beltran JL, Kobayashi Elliott KT, Michalewicz-Kragh B. Psychological and functional outcomes following a randomized controlled trial of surf and hike therapy for U.S. service members. Front Psychol. 2023 Jun 8;14:1185774. doi: 10.3389/fpsyg.2023.1185774. eCollection 2023.