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NCT Number: NCT06858189

Promoting Active Therapy: Path to Wellness

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kansas State University

Manhattan, Kansas, 66506, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk-and-talk therapy

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Self-efficacy for physical activity

    Time frame: baseline, 10 weeks

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

  2. Self-efficacy for time in nature

    Time frame: baseline, 10 weeks

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

  3. Physical activity

    Time frame: Weekly throughout the 10-week intervention

    Average MVPA and daily steps measured via Fitbit inspire 3 devices

  4. Time in nature

    Time frame: Weekly throughout the 10-week intervention

    Measured via NatureDose app

Other outcomes

  1. Depression

    Time frame: baseline, 10 weeks

    Measured via PHQ-9

  2. Anxiety

    Time frame: baseline, 10 weeks

    Measured via GAD-7

Study contacts

Contact information is provided by the study sponsor or research team.

Emily L Mailey, PhD

CONTACT

[email protected]

847-224-1199

Gina M Besenyi, PhD

CONTACT

[email protected]

785-532-6765

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Collaborators

  • REI Cooperative Action Fund

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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