Major Depressive DisorderNCT03302611
Trial of Surf and Hike Therapy for Major Depressive Disorder
A study testing Physical Activity-based Interventions in people with Major Depressive Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Physical Activity-based Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
- Service members who are currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Physical Activity-based Interventions
- Keywords
- major depressive disorder, military, surf therapy, hike therapy, randomized controlled trial
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity-based InterventionsBehavioural
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical Activity-based Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (6)
PTSD Checklist (PCL-5)
The PCL-5 is a self-report instrument assessing PTSD symptom severity.
Measured: 5 months
Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a self-report instrument that assesses the presence and severity of generalized anxiety disorder.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report measure that assesses the nature, severity, and impact of insomnia.
Measured: 5 months
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-report instrument that assesses the presence and severity
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Jan 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Naval Health Research Center
- Responsible party
- Principal investigator, Kristen Walter, United States Naval Medical Center, San Diego
- Investigators
- Cynthia J. Thomsen, Ph.D., Principal investigator, Naval Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302611
- Sponsor's protocol ID
- NMCSD.2017.0007
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2017
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31485546Walter 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.
PubMed 36805672Otis 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.
PubMed 38976384Glassman 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.
PubMed 38397730Walter 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.
PubMed 37359884
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03302611
- Acronym / sponsor ID
- NMCSD.2017.0007
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, military, surf therapy, hike therapy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Naval Health Research Center
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surf Therapy | Experimental | Behavioral: Physical Activity-based InterventionsParticipants 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. |
| Hike Therapy | Active comparator | Behavioral: Physical Activity-based InterventionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
- Service members who are currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity-based InterventionsParticipants will be randomized to one of two physical activity-based interventions, surf or hike therapy. | Behavioural | Hike Therapy, Surf Therapy |
Primary outcome
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.
6 secondary outcomes
PTSD Checklist (PCL-5)
Time frame: 5 months
Generalized Anxiety Disorder (GAD-7)
Time frame: 5 months
Short Form Health Survey - 36 Item, Version 2 (SF-36)
Time frame: 5 months
Positive and Negative Affect scales (PANAS)
Time frame: 5 months
Insomnia Severity Index (ISI)
Time frame: 5 months
Patient Health Questionnaire (PHQ-9)
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 31485546Walter 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 publication: PubMed 36805672Walter 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 publication: PubMed 38976384Otis 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.
- Results publication: PubMed 38397730Glassman 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.
- Results publication: PubMed 37359884Walter 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.
- Link to outcomes manuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J. Thomsen, Ph.D. principal investigator
Naval Health Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity-based Interventions in people with Major Depressive Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302611, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.