Major Depressive Disorder
Conditions
Keywords
major depressive disorder, military, surf therapy, hike therapy, randomized controlled trial
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.
Interventions
BEHAVIORALPhysical Activity-based Interventions
Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
Sponsors
Naval Health Research Center
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor will be blinded to participants' intervention condition.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist (PCL-5) | 5 months | The PCL-5 is a self-report instrument assessing PTSD symptom severity. |
| Generalized Anxiety Disorder (GAD-7) | 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) | 5 months | The SF-36 is a widely used questionnaire that assesses functioning physical and mental health based on eight summary measures. |
| Insomnia Severity Index (ISI) | 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) | 5 months | The PHQ-9 is a self-report instrument that assesses the presence and severity |
| Positive and Negative Affect scales (PANAS) | 5 months | PANAS is a self-report instrument that measures the extent of 20 feelings and emotions experienced within the past few hours. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating Scale (PRS) | 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). |
Countries
United States
Outcome results
None listed