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Trial of Surf and Hike Therapy for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03302611
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Tracking Information
First Submitted Date  ICMJE October 2, 2017
First Posted Date  ICMJE October 5, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • 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.
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03302611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • PTSD Checklist (PCL-5) [ Time Frame: 5 months ]
    The PCL-5 is a self-report instrument assessing PTSD symptom severity.
  • 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.
  • 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.
  • 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.
  • 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.
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 5 months ]
    The PHQ-9 is a self-report instrument that assesses the presence and severity
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • PTSD Checklist (PCL-5) [ Time Frame: 5 months ]
    The PCL-5 is a self-report instrument assessing PTSD symptom severity.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2017)
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial of Surf and Hike Therapy for Major Depressive Disorder
Official Title  ICMJE A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Behavioral: Physical Activity-based Interventions
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
Study Arms  ICMJE
  • Experimental: Surf Therapy
    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.
    Intervention: Behavioral: Physical Activity-based Interventions
  • Active Comparator: Hike Therapy
    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: Behavioral: Physical Activity-based Interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2017)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03302611
Other Study ID Numbers  ICMJE NMCSD.2017.0007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party United States Naval Medical Center, San Diego
Study Sponsor  ICMJE United States Naval Medical Center, San Diego
Collaborators  ICMJE Naval Health Research Center
Investigators  ICMJE
Principal Investigator: Cynthia J. Thomsen, Ph.D. Naval Health Research Center
PRS Account United States Naval Medical Center, San Diego
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP