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Trial of Surf and Hike Therapy for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity-based Interventions
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, military, surf therapy, hike therapy, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surf Therapy

Hike Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PTSD Checklist (PCL-5)
The PCL-5 is a self-report instrument assessing PTSD symptom severity.
Generalized Anxiety Disorder (GAD-7)
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)
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)
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)
The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-report instrument that assesses the presence and severity

Full Information

First Posted
October 2, 2017
Last Updated
March 10, 2023
Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03302611
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, military, surf therapy, hike therapy, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to participants' intervention condition.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surf Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Hike Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity-based Interventions
Intervention Description
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
PTSD Checklist (PCL-5)
Description
The PCL-5 is a self-report instrument assessing PTSD symptom severity.
Time Frame
5 months
Title
Generalized Anxiety Disorder (GAD-7)
Description
The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.
Time Frame
5 months
Title
Short Form Health Survey - 36 Item, Version 2 (SF-36)
Description
The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.
Time Frame
5 months
Title
Positive and Negative Affect scales (PANAS)
Description
PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.
Time Frame
5 months
Title
Insomnia Severity Index (ISI)
Description
The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.
Time Frame
5 months
Title
Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 is a self-report instrument that assesses the presence and severity
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Pain Rating Scale (PRS)
Description
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).
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J. Thomsen, Ph.D.
Organizational Affiliation
Naval Health Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31485546
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.
Results Reference
background
PubMed Identifier
36805672
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.
Results Reference
result
Links:
URL
https://doi.org/10.1186/s12888-022-04452-7
Description
Link to outcomes manuscript

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Trial of Surf and Hike Therapy for Major Depressive Disorder

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