Promoting Active Therapy: Path to Wellness

NCT ID: NCT06858189

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-05-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Walk-and-talk therapy

Intervention Type: 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.

Waitlist control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Walk-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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Path to Wellness

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

REI Cooperative Action Fund

UNKNOWN

Sponsor Role: collaborator

Kansas State University

OTHER

Sponsor Role: lead

Responsible Party

Emily Mailey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kansas State University

Manhattan, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily L Mailey, PhD

Role: CONTACT

emailey@ksu.edu

847-224-1199

Gina M Besenyi, PhD

Role: CONTACT

gbesenyi@ksu.edu

785-532-6765

Other Identifiers

IRB12197

Identifier Type: -

Identifier Source: org_study_id