- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06858189
Promoting Active Therapy: Path to Wellness
Can Nature-based Physical Activity Improve Symptoms of Depression and Anxiety?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For this project, we will recruit ten licensed therapists whose caseload includes adults with depression and anxiety. We aim to recruit therapists who practice in northeast Kansas. Our team will lead a 3-hour in-person training for participating therapists that covers project aims and procedures, benefits of nature-based physical activity for mental health, identifying and enrolling suitable clients for participation, recommending and engaging in nature-based physical activity with clients, and completing project assessments.
Following the training, each therapist will recruit six clients aged 18-65 who are willing to participate in a 10-week research study and meet the following criteria: 1) diagnosed depressive or anxiety disorder, 2) able to safely engage in moderate physical activity, and 3) willing to complete all research requirements. Clients who are part of an underrepresented minority group (i.e., racial/ethnic minority, low SES, LGTBQ) will be prioritize during recruitment. Therapists will invite eligible clients to participate in the study, and those who agree will sign an informed consent document. Clients will be randomly assigned to the intervention or active waitlist control (usual care) condition. All participants will receive a Fitbit and download the NatureDose app. During the 10-week intervention, clients and therapists will engage in walk-and-talk therapy outdoors in natural settings during weekly therapy sessions. In addition, therapists will work with clients to set realistic goals for increased nature-based physical activity outside of the therapy setting. Therapists will check in with clients weekly regarding their progress and assist with goal revision, barrier planning, and self-monitoring. Control participants will receive information about nature-based physical activity, and then will receive the full intervention after 10 weeks.
All participating clients will complete surveys assessing depression and anxiety symptoms at baseline (following informed consent) and at the end of the 10-week intervention. Throughout the 10-week intervention, therapists will keep a weekly log of frequency and duration of walk-and talk sessions. Clients will also keep a weekly log of nature-based physical activity, use the NatureDose app to measure time spent in nature each day, and wear a Fitbit to track their daily physical activity. At the end of the intervention, clients will complete a brief satisfaction survey, and therapists will complete an individual interview with the research team.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Emily L Mailey, PhD
- Phone Number: 847-224-1199
- Email: emailey@ksu.edu
Study Contact Backup
- Name: Gina M Besenyi, PhD
- Phone Number: 785-532-6765
- Email: gbesenyi@ksu.edu
Study Locations
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-
Kansas
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Manhattan, Kansas, United States, 66506
- Recruiting
- Kansas State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current client of a participating therapist who has completed study training
- Diagnosed depressive or anxiety disorder
- Able to safely engage in moderate physical activity
- Willing to complete all study requirements
Exclusion Criteria:
- Planning to discontinue therapy in less than 6 months
- Active suicidal ideation
- Does not pass exercise risk screener
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (immediate start)
Participants will engage in walk-and-talk therapy during weekly sessions with their therapist and will set goals for engaging in nature-based physical activity on their own outside of therapy.
|
During the 10-week intervention, clients and therapists will engage in walk-and-talk therapy outdoors in natural settings during weekly therapy sessions.
In addition, therapists will work with clients to set realistic goals for increased nature-based physical activity outside of the therapy setting.
Therapists will check in with clients weekly regarding their progress and assist with goal revision, barrier planning, and self-monitoring.
Other Names:
|
|
No Intervention: Waitlist control
Participants will receive generic educational materials about nature-based physical activity and local parks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation in walk-and-talk therapy
Time Frame: Weekly throughout the 10-week intervention
|
Therapists will keep logs of weekly attendance and participation in walk-and-talk therapy during sessions.
Outcome will be calculated as a percentage of offered sessions.
|
Weekly throughout the 10-week intervention
|
|
Perceived therapist support for nature-based physical activity
Time Frame: End of intervention (after 10 weeks)
|
Participating clients will complete a survey indicating how frequently their therapist asks about physical activity, recommends physical activity, engages in physical activity with the client, etc.
|
End of intervention (after 10 weeks)
|
|
Acceptability
Time Frame: End of intervention (after 10 weeks)
|
At the end of the intervention, clients will complete a survey indicating how much the discussions/sessions were helpful, enjoyable, informative, etc.
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End of intervention (after 10 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy for physical activity
Time Frame: baseline, 10 weeks
|
Measured with a modified version of the barriers self-efficacy scale
|
baseline, 10 weeks
|
|
Self-efficacy for time in nature
Time Frame: baseline, 10 weeks
|
Measured with the self-efficacy for spending time in nature scale
|
baseline, 10 weeks
|
|
Physical activity
Time Frame: Weekly throughout the 10-week intervention
|
Average MVPA and daily steps measured via Fitbit inspire 3 devices
|
Weekly throughout the 10-week intervention
|
|
Time in nature
Time Frame: Weekly throughout the 10-week intervention
|
Measured via NatureDose app
|
Weekly throughout the 10-week intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: baseline, 10 weeks
|
Measured via PHQ-9
|
baseline, 10 weeks
|
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Anxiety
Time Frame: baseline, 10 weeks
|
Measured via GAD-7
|
baseline, 10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB12197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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