NCT06858189

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
1mo left

Started Feb 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025May 2026

First Submitted

Initial submission to the registry

February 27, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 27, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

therapynature prescriptionspark prescriptions (ParkRx)exercisemental healthwalk-and-talk

Outcome Measures

Primary Outcomes (3)

  • 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.

    Weekly throughout the 10-week intervention

  • 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.

    End of intervention (after 10 weeks)

  • Acceptability

    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 Outcomes (4)

  • Self-efficacy for physical activity

    baseline, 10 weeks

  • Self-efficacy for time in nature

    baseline, 10 weeks

  • Physical activity

    Weekly throughout the 10-week intervention

  • Time in nature

    Weekly throughout the 10-week intervention

Other Outcomes (2)

  • Depression

    baseline, 10 weeks

  • Anxiety

    baseline, 10 weeks

Study Arms (2)

Intervention (immediate start)

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

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

Interventions

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
Intervention (immediate start)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas State University

Manhattan, Kansas, 66506, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Central Study Contacts

Emily L Mailey, PhD

CONTACT

Gina M Besenyi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

February 28, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations