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Trial record 19 of 5694 for:    "depression" OR "clinical depression" OR "major depression" OR "major depressive disorder" OR "unipolar depression"

Trial of Surf and Hike Therapy for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03302611
Recruitment Status : Not yet recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 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.
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surf Therapy
Participants randomized to surf therapy will receive 6 sessions (i.e., once per week for 6 weeks). Each surf therapy session is 1.5 to 3 hours in duration and occurs in a group setting. Each service member is paired with a surf instructor who typically works with them each week for the length of the 6-week program. Participant goals are individually-tailored to the service member (based on participant's level of comfort in the water, etc.) and can incorporate both physical and psychological objectives
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 randomized to hike therapy will receive 6 sessions (i.e., once per week for 6 weeks). Each hike therapy session is 1.5 to 3 hours in duration and occurs in a group setting. During hike therapy, service members may hike together or at a self-selected pace. Participant goals are individually-tailored to the service member (based on participant's limitations for hiking, etc.) and can incorporate both physical and psychological objectives
Behavioral: Physical Activity-based Interventions
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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.

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: 5 months ]
    The PHQ-9 is a self-report instrument that assesses the presence and severity of major depressive disorder.

  3. Mini International Neuropsychiatric Interview (MINI-7) [ Time Frame: 5 months ]
    The MINI-7 is a structured diagnostic interview designed to assess a wide range of psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.


Secondary Outcome Measures :
  1. PTSD Checklist (PCL-5) [ Time Frame: 5 months ]
    The PCL-5 is a self-report instrument assessing PTSD symptom severity.

  2. Generalized Anxiety Disorder (GAD-7) [ Time Frame: 5 months ]
    The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.

  3. Short Form Health Survey - 36 Item, Version 2 (SF-36) [ Time Frame: 5 months ]
    The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.

  4. Positive and Negative Affect scales (PANAS) [ Time Frame: 5 months ]
    PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.

  5. Insomnia Severity Index (ISI) [ Time Frame: 5 months ]
    The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.


Other Outcome Measures:
  1. Pain Rating Scale (PRS) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302611


Contacts
Contact: Betty Michalewicz-Kragh, M.S. 619-532-7727 betty.michalewiczkragh.civ@mail.mil
Contact: Kristen H Walter, Ph.D. 619-553-0546 kristen.h.walter.ctr@mail.mil

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Naval Health Research Center

Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT03302611     History of Changes
Other Study ID Numbers: NMCSD.2017.0007
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United States Naval Medical Center, San Diego:
major depressive disorder
military
surf therapy
hike therapy
randomized controlled trial

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms