Walk-and-Talk Therapy for Depression and Anxiety

Overseen By Gina M Besenyi, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kansas State University

Disqualifiers: Active suicidal ideation, exercise risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

60 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your therapist or the trial coordinators.

What data supports the effectiveness of the treatment Walk-and-talk therapy for depression and anxiety?

Research shows that cognitive-behavioral therapy (CBT), which is a part of walk-and-talk therapy, is effective in reducing symptoms of depression and anxiety. Studies also highlight the importance of a strong therapeutic alliance (the relationship between therapist and patient) in improving treatment outcomes, which is a key component of walk-and-talk therapy. ^{1 2 3 4 5}

Is walk-and-talk therapy safe for treating depression and anxiety?

The research does not provide specific safety data for walk-and-talk therapy, but walking as part of therapy has been studied and generally considered safe for anxiety disorders. ^{6 7 8 9 10}

How is walk-and-talk therapy different from other treatments for depression and anxiety?

Walk-and-talk therapy is unique because it combines physical activity with traditional talk therapy, allowing patients to engage in therapy sessions while walking. This approach may offer additional benefits from exercise, which has been shown to help reduce symptoms of depression and anxiety. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with depression and anxiety who are currently seeing a therapist. Participants should be interested in nature-based physical activity. Therapists must have the appropriate caseload and agree to training. People with conditions that limit outdoor activity or those unable to commit to the full 10-week program cannot join.

Inclusion Criteria

My therapist is part of the study and trained for it.

I have been diagnosed with depression or an anxiety disorder.

Willing to complete all study requirements

Exclusion Criteria

I am currently having thoughts about harming myself.

Planning to discontinue therapy in less than 6 months

Does not pass exercise risk screener

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Therapists receive a 3-hour in-person training covering project aims, procedures, and benefits of nature-based physical activity for mental health

1 day

Treatment

Participants engage in a 10-week intervention with walk-and-talk therapy outdoors during weekly sessions and set goals for nature-based physical activity

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in depression, anxiety, and nature-based physical activity after the intervention

4 weeks

Treatment Details

Interventions

• Walk-and-talk therapy

Trial Overview The study tests walk-and-talk therapy, where clients engage in outdoor sessions focusing on active strategies while discussing mental health issues. Over 10 weeks, half of the participants will receive this intervention; the other half won't, allowing comparison of changes in mental health and physical activity levels.

Participant Groups

Group I: Intervention (immediate start) Experimental Treatment 1 Intervention

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 II: Waitlist control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kansas State University

Lead Sponsor

Trials

39

Recruited

13,400+

REI Cooperative Action Fund

Collaborator

Trials

2

Recruited

1,600+

Findings from Research

In a study of 80 psychiatric outpatients undergoing group cognitive-behavioral therapy (CBT) for depression, baseline characteristics such as symptoms of depression and quality of life were linked to patients' expectations for improvement, highlighting the importance of addressing these factors early in treatment.

Patients' expectations for treatment outcomes were found to influence the quality of the therapeutic alliance and were positively associated with improvements in anxiety, quality of life, and interpersonal problems, suggesting that fostering hope and optimism in the initial therapy sessions can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forecasting success: patients' expectations for improvement and their relations to baseline, process and outcome variables in group cognitive-behavioural therapy for depression. Tsai, M., Ogrodniczuk, JS., Sochting, I., et al.[2022]

A study of 58 anxious depressed outpatients receiving case formulation-driven cognitive-behavior therapy (CBT) showed significant improvements in anxiety and depression, comparable to results from randomized controlled trials of established therapies.

The approach, which included weekly outcome monitoring and adjunct therapies as needed, suggests that patients with multiple comorbidities can effectively benefit from tailored, evidence-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic outcome of case formulation-driven cognitive-behavior therapy for anxious depressed outpatients. Persons, JB., Roberts, NA., Zalecki, CA., et al.[2022]

After a 6-week intensive inpatient cognitive behavior therapy program, 59.4% of the 37 patients with depression and anxiety reported significant improvements in their condition, as assessed by clinical global impression.

Quality of life improved in several areas, including work, education, and social relations, although no significant changes were noted in marital relations, general health, or finances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in depression and anxiety disorders: an exploratory follow-up study after intensive inpatient cognitive behaviour therapy. Lenz, G., Demal, U.[2018]

In a study of 523 adults with major depressive disorder (MDD), those with non-social anxiety disorders experienced worse outcomes during cognitive therapy (CT), indicating that these comorbidities can reduce the treatment's effectiveness.

Conversely, patients with social anxiety disorder showed greater reductions in depressive symptoms during CT, but they also faced increased social avoidance, suggesting that tailored approaches may be necessary for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do comorbid social and other anxiety disorders predict outcomes during and after cognitive therapy for depression? Vittengl, JR., Clark, LA., Smits, JAJ., et al.[2020]

In a study involving 225 depressed outpatients across various treatments, a strong therapeutic alliance significantly improved treatment outcomes for both psychotherapy and pharmacotherapy, including placebo.

The effectiveness of the therapeutic alliance was primarily influenced by the patient's contribution, rather than the therapist's, highlighting the importance of patient engagement in achieving better clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the therapeutic alliance in psychotherapy and pharmacotherapy outcome: findings in the National Institute of Mental Health Treatment of Depression Collaborative Research Program. Krupnick, JL., Sotsky, SM., Simmens, S., et al.[2022]

A randomized trial involving 74 participants with anxiety disorders showed that adding a home-based walking program to standard cognitive behavioral therapy (GCBT) significantly reduced levels of depression, anxiety, and stress compared to GCBT alone.

The results suggest that incorporating exercise into therapy could enhance treatment outcomes for individuals with panic disorder, generalized anxiety disorder, or social phobia, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting walking as an adjunct intervention to group cognitive behavioral therapy for anxiety disorders--a pilot group randomized trial. Merom, D., Phongsavan, P., Wagner, R., et al.[2022]

A combination of talk therapy and medication was found to be the most effective treatment for depression and anxiety, but talk therapy alone, especially with 13 or more sessions, was nearly as effective.

While medications provided quicker symptom relief, they often required multiple trials to find the right one without side effects, with 40% of users reporting adverse sexual side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs vs. talk therapy: 3,079 readers rate their care for depression and anxiety. [2022]

A study involving 99 therapists found that those with experience in dance/movement therapy (DMT) were more likely to perceive the combination of DMT and cognitive behavioral therapy (CBT) as an effective treatment for anxiety disorders in children.

The actual use of the combined DMT and CBT approaches by therapists was influenced by their beliefs about efficiency, rather than their overall sense of efficacy in treating children with anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Dance/Movement Therapy with Cognitive Behavioral Therapy in Treatment of Children with Anxiety Disorders: Factors Explaining Therapists' Attitudes. Weitz, N., Opre, A.[2022]

In a study of 369 outpatients with panic disorder and agoraphobia, comorbid depression did not significantly hinder the effectiveness of cognitive-behavioral therapy (CBT) in reducing anxiety symptoms, although there were slight reductions in clinician-rated outcomes immediately after treatment.

CBT was effective in improving depressive symptoms regardless of whether patients had comorbid depression, indicating that treatment for panic disorder and agoraphobia can also benefit patients' mental health overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression does not affect the treatment outcome of CBT for panic and agoraphobia: results from a multicenter randomized trial. Emmrich, A., Beesdo-Baum, K., Gloster, AT., et al.[2018]

Cognitive Behavioral Therapy (CBT) is an effective treatment for all levels of major depression, proving to be as effective and more durable than medication alone.

Combining CBT with medication can enhance treatment response and prolong benefits, especially when CBT is introduced after successful pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for depression. Sudak, DM.[2022]

A feasibility study is being conducted to evaluate a 1-day training workshop for high-intensity cognitive behavioral therapy (CBT) therapists, aimed at improving their skills in working with clients who have personality difficulties alongside anxiety and depression.

The study will assess whether this training can enhance therapist confidence and potentially improve treatment outcomes for individuals with these comorbid conditions, providing a foundation for future larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-randomised feasibility study of training workshops for Talking Therapies service high-intensity therapists to optimise depression and anxiety outcomes for individuals with co-morbid personality difficulties: a study protocol. Warbrick, LA., Dunn, BD., Moran, PA., et al.[2023]

A randomized controlled trial with 121 participants showed that an Internet-based tailored guided self-help treatment for major depression was more effective than a standardized treatment, especially for individuals with higher baseline depression and comorbid symptoms.

Both tailored and standardized treatments led to improvements in depression, anxiety, and quality of life, with effects maintained at a 6-month follow-up, highlighting the potential of personalized approaches in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored vs. standardized internet-based cognitive behavior therapy for depression and comorbid symptoms: a randomized controlled trial. Johansson, R., Sjöberg, E., Sjögren, M., et al.[2023]

An exercise program was found to be an effective treatment option for individuals with depression and anxiety, showing positive results in symptom reduction.

The study compared the effects of exercise with transdiagnostic cognitive behavioral group therapy (TCBGT) and indicated that exercise can be as beneficial as TCBGT for managing these mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Depression and Anxiety. A Comparison to Transdiagnostic Cognitive Behavioral Therapy. Ólafsdóttir, KB., Kristjánsdóttir, H., Saavedra, JM.[2019]

Cognitive-behavioral therapy (CBT) and interpersonal therapy have shown moderate effectiveness in treating depression over the past 50 years, but the overall effect size has not improved and may even be decreasing.

While these therapies can reduce depressive symptoms, there is no strong evidence that they prevent the onset of depressive disorders, indicating a need for new approaches in both treatment and prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Optimizing Depression Prevention: The Way Forward? Merry, SN.[2021]

In a study involving 290 participants with major depressive disorder (MDD), both disorder-specific cognitive behavior therapy (DS-CBT) and transdiagnostic CBT (TD-CBT) showed large reductions in MDD symptoms, averaging over 45%.

The study found no significant differences in efficacy between the clinician-guided and self-guided formats of CBT, indicating that both approaches are effective for treating MDD and associated anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: A randomized controlled trial. Titov, N., Dear, BF., Staples, LG., et al.[2022]

References

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Forecasting success: patients' expectations for improvement and their relations to baseline, process and outcome variables in group cognitive-behavioural therapy for depression. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Naturalistic outcome of case formulation-driven cognitive-behavior therapy for anxious depressed outpatients. [2022]

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Quality of life in depression and anxiety disorders: an exploratory follow-up study after intensive inpatient cognitive behaviour therapy. [2018]

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Do comorbid social and other anxiety disorders predict outcomes during and after cognitive therapy for depression? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The role of the therapeutic alliance in psychotherapy and pharmacotherapy outcome: findings in the National Institute of Mental Health Treatment of Depression Collaborative Research Program. [2022]

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Promoting walking as an adjunct intervention to group cognitive behavioral therapy for anxiety disorders--a pilot group randomized trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Drugs vs. talk therapy: 3,079 readers rate their care for depression and anxiety. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Combining Dance/Movement Therapy with Cognitive Behavioral Therapy in Treatment of Children with Anxiety Disorders: Factors Explaining Therapists' Attitudes. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Depression does not affect the treatment outcome of CBT for panic and agoraphobia: results from a multicenter randomized trial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for depression. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Non-randomised feasibility study of training workshops for Talking Therapies service high-intensity therapists to optimise depression and anxiety outcomes for individuals with co-morbid personality difficulties: a study protocol. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Tailored vs. standardized internet-based cognitive behavior therapy for depression and comorbid symptoms: a randomized controlled trial. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Depression and Anxiety. A Comparison to Transdiagnostic Cognitive Behavioral Therapy. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Editorial: Optimizing Depression Prevention: The Way Forward? [2021]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: A randomized controlled trial. [2022]