ClinicalTrials.gg
RecruitingNCT06858189Updated Mar 5, 2025

Promoting Active Therapy: Path to Wellness

A Phase 2 interventional study of Walk-and-talk therapy in Depression, Anxiety, Physical Activity and Time in Nature, sponsored by Kansas State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Kansas State University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Depression, Anxiety
  • Physical Activity
  • Time in Nature
  • Self-Efficacy
  • Feasibility Pilot Study

Keywords

  • therapy
  • nature prescriptions
  • park prescriptions (ParkRx)
  • exercise
  • mental health
  • walk-and-talk
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Kansas State University is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Planning to discontinue therapy in less than 6 months
  • Active suicidal ideation
  • Does not pass exercise risk screener
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Behavioral: Walk-and-talk therapy

  • No intervention
    Waitlist control

    Participants will receive generic educational materials about nature-based physical activity and local parks.

Interventions

  • BehavioralWalk-and-talk 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.

    Also known as: Path to Wellness

06

What researchers measure

Primary outcomes

  1. Participation in walk-and-talk therapy

    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.

    Time frame: Weekly throughout the 10-week intervention

  2. Perceived therapist support for nature-based physical activity

    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.

    Time frame: End of intervention (after 10 weeks)

  3. Acceptability

    At the end of the intervention, clients will complete a survey indicating how much the discussions/sessions were helpful, enjoyable, informative, etc.

    Time frame: End of intervention (after 10 weeks)

Secondary outcomes

  1. Self-efficacy for physical activity

    Measured with a modified version of the barriers self-efficacy scale

    Time frame: baseline, 10 weeks

  2. Self-efficacy for time in nature

    Measured with the self-efficacy for spending time in nature scale

    Time frame: baseline, 10 weeks

  3. Physical activity

    Average MVPA and daily steps measured via Fitbit inspire 3 devices

    Time frame: Weekly throughout the 10-week intervention

  4. Time in nature

    Measured via NatureDose app

    Time frame: Weekly throughout the 10-week intervention

Other outcomes

  1. Depression

    Measured via PHQ-9

    Time frame: baseline, 10 weeks

  2. Anxiety

    Measured via GAD-7

    Time frame: baseline, 10 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06858189
Lead sponsor
Kansas State University
Collaborators
REI Cooperative Action Fund
Responsible party
Emily Mailey (Associate Professor, Kansas State University) — Principal investigator
First posted
Mar 5, 2025
Start date
Feb 28, 2025
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Mar 5, 2025

Study contacts

Emily L Mailey, PhD
Contact
emailey@ksu.edu
847-224-1199
Gina M Besenyi, PhD
Contact
gbesenyi@ksu.edu
785-532-6765

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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