NCT03302611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

October 2, 2017

Last Update Submit

November 13, 2024

Conditions

Keywords

major depressive disordermilitarysurf therapyhike therapyrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • PTSD Checklist (PCL-5)

    5 months

  • Generalized Anxiety Disorder (GAD-7)

    5 months

  • Short Form Health Survey - 36 Item, Version 2 (SF-36)

    5 months

  • Positive and Negative Affect scales (PANAS)

    5 months

  • Insomnia Severity Index (ISI)

    5 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Pain Rating Scale (PRS)

    5 months

Study Arms (2)

Surf Therapy

EXPERIMENTAL

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

Hike Therapy

ACTIVE COMPARATOR

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

Interventions

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

Hike TherapySurf Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
  • Service members who are currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (5)

  • 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.

    PMID: 31485546BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Cynthia J. Thomsen, Ph.D.

    Naval Health Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will be blinded to participants' intervention condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Psychologist

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

January 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations