<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03302611</url>
  </required_header>
  <id_info>
    <org_study_id>NMCSD.2017.0007</org_study_id>
    <nct_id>NCT03302611</nct_id>
  </id_info>
  <brief_title>Trial of Surf and Hike Therapy for Major Depressive Disorder</brief_title>
  <official_title>A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naval Health Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>United States Naval Medical Center, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study uses a randomized controlled trial design to compare the psychological effects of&#xD;
      surf therapy to hike therapy in active duty service members who have been diagnosed with&#xD;
      major depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, longitudinal randomized controlled trial will enroll up to 86 active duty&#xD;
      service members with major depressive disorder who are seeking surf or hike therapy as part&#xD;
      of their standard medical care. Participants will be randomly assigned to receive 6 weeks of&#xD;
      either surf or hike therapy. Assessor-administered and self-report measures will be completed&#xD;
      at pre- and post-program, as well as three months following program completion. Participants&#xD;
      also will complete brief, self-report assessments before and after each program activity&#xD;
      session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessor will be blinded to participants' intervention condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery-Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>5 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist (PCL-5)</measure>
    <time_frame>5 months</time_frame>
    <description>The PCL-5 is a self-report instrument assessing PTSD symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder (GAD-7)</measure>
    <time_frame>5 months</time_frame>
    <description>The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey - 36 Item, Version 2 (SF-36)</measure>
    <time_frame>5 months</time_frame>
    <description>The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect scales (PANAS)</measure>
    <time_frame>5 months</time_frame>
    <description>PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>5 months</time_frame>
    <description>The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>5 months</time_frame>
    <description>The PHQ-9 is a self-report instrument that assesses the presence and severity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain Rating Scale (PRS)</measure>
    <time_frame>5 months</time_frame>
    <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).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Surf Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hike Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity-based Interventions</intervention_name>
    <description>Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.</description>
    <arm_group_label>Hike Therapy</arm_group_label>
    <arm_group_label>Surf Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a military service member seeking surf or hike therapy as part of the Wounded, Ill,&#xD;
             and Injured Wellness program at Naval Medical Center San Diego;&#xD;
&#xD;
          -  Have medical clearance to participate in these programs;&#xD;
&#xD;
          -  Have a current diagnosis of Major Depressive Disorder based on DSM-5 criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Service members who are currently receiving surf or hike therapy (i.e., have already&#xD;
             started attending program sessions);&#xD;
&#xD;
          -  Service members who are currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia J. Thomsen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naval Health Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1186/s12888-022-04452-7</url>
    <description>Link to outcomes manuscript</description>
  </link>
  <reference>
    <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>
    <PMID>31485546</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>36805672</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United States Naval Medical Center, San Diego</investigator_affiliation>
    <investigator_full_name>Kristen Walter</investigator_full_name>
    <investigator_title>Clinical Research Psychologist</investigator_title>
  </responsible_party>
  <keyword>major depressive disorder</keyword>
  <keyword>military</keyword>
  <keyword>surf therapy</keyword>
  <keyword>hike therapy</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03302611
org study id: NMCSD.2017.0007
nct id: NCT03302611
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessor will be blinded to participants' intervention condition.
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
time frame: 5 months
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.
measure: PTSD Checklist (PCL-5)
time frame: 5 months
description: The PCL-5 is a self-report instrument assessing PTSD symptom severity.
measure: Generalized Anxiety Disorder (GAD-7)
time frame: 5 months
description: The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.
measure: Short Form Health Survey - 36 Item, Version 2 (SF-36)
time frame: 5 months
description: The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures.
measure: Positive and Negative Affect scales (PANAS)
time frame: 5 months
description: PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours.
measure: Insomnia Severity Index (ISI)
time frame: 5 months
description: The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.
measure: Patient Health Questionnaire (PHQ-9)
time frame: 5 months
description: The PHQ-9 is a self-report instrument that assesses the presence and severity
measure: Pain Rating Scale (PRS)
time frame: 5 months
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).
arm group label: Surf Therapy
arm group type: Experimental
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 group label: Hike Therapy
arm group type: Active Comparator
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: Physical Activity-based Interventions
description: Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
arm group label: Hike Therapy
arm group label: Surf Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cynthia J. Thomsen, Ph.D.
role: Principal Investigator
affiliation: Naval Health Research Center
facility: 
country: United States
url: https://doi.org/10.1186/s12888-022-04452-7
description: Link to outcomes manuscript
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.
PMID: 31485546
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.
PMID: 36805672
responsible party type: Principal Investigator
investigator affiliation: United States Naval Medical Center, San Diego
investigator full name: Kristen Walter
investigator title: Clinical Research Psychologist
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No