Promoting Active Therapy: Path to Wellness

February 27, 2025 updated by: Emily Mailey, Kansas State University

Can Nature-based Physical Activity Improve Symptoms of Depression and Anxiety?

This project will examine changes in depression and anxiety following a 10-week intervention promoting nature-based physical activity in mental health settings. We will recruit ten licensed therapists whose caseload includes adults with depression and anxiety. Following a training by our team, each participating therapist will recruit six clients, who will be randomly assigned to the intervention or control condition. Clients in the intervention condition will engage in walk-and-talk therapy outdoors during weekly sessions and discuss strategies for being active outdoors on their own. We will assess changes in depression, anxiety, and nature-based physical activity in both groups.

Study Overview

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

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emily L Mailey, PhD
  • Phone Number: 847-224-1199
  • Email: emailey@ksu.edu

Study Contact Backup

Study Locations

    • Kansas
      • Manhattan, Kansas, United States, 66506
        • Recruiting
        • Kansas State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Path to Wellness
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.
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
Anxiety
Time Frame: baseline, 10 weeks
Measured via GAD-7
baseline, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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