Behavioral Exposure Therapy for Exercise Intolerance

(BE-FIT Trial)

Recruiting at 1 trial location

Overseen By Samantha G Farris, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Cognitive impairment, Severe chronic conditions, 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: 15

Duration: 6 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new treatment, Behavioral Exposure for Interoceptive Tolerance (BE-FIT), can reduce exercise anxiety in individuals undergoing cardiac rehabilitation. BE-FIT involves acclimating to exercise-related sensations, avoiding habits that might impede progress, and using a Fitbit to track activity and set goals. The trial will compare BE-FIT to a health education program to determine which is more effective in improving exercise habits. Individuals medically approved for cardiac rehab and experiencing high levels of exercise anxiety might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is safe for participants. Previous studies found that BE-FIT is not only feasible and acceptable but also easy for participants to manage. Participants experienced less anxiety about exercise, and no serious side effects occurred. This suggests that the treatment is safe, particularly in helping individuals manage exercise-related anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Exposure Therapy for Exercise Intolerance because it targets exercise anxiety in a unique way. Unlike standard treatments that might focus solely on fitness or physical activity levels, this approach integrates cognitive-behavioral strategies to directly address fears related to exercise. The therapy includes exposure to feared bodily sensations, discourages safety behaviors, and uses a Fitbit to provide real-time feedback and help set activity goals. This comprehensive method aims to not only improve physical endurance but also reduce anxiety, making it a promising alternative for those struggling with exercise intolerance.

What evidence suggests that the BE-FIT intervention is effective for reducing exercise anxiety in cardiac rehabilitation patients?

Research shows that the BE-FIT program, which participants in this trial may receive, can help reduce anxiety about exercising. In earlier studies, participants increased their physical activity, such as taking more steps each day and engaging in more moderate-to-vigorous exercise. The program involves confronting feelings that make exercise intimidating, avoiding habits that provide false security, and wearing a wrist monitor for feedback and activity goal setting. These steps aim to help participants feel more comfortable with exercise over time. Early results suggest that BE-FIT is safe, well-received, and effective in helping people maintain their exercise routines. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals over 40 with high exercise anxiety, approved for cardiac rehab, and not very active. They must speak English and have no severe cognitive impairments or chronic conditions that could interfere with the study.

Inclusion Criteria

I am enrolled in a heart health rehab program.

You haven't been very active, doing less than 90 minutes of moderate-to-vigorous exercise each day in the past three months.

You experience high levels of anxiety when it comes to exercise (scoring 30 or higher on a specific questionnaire).

Exclusion Criteria

It is expected that the patient will not survive during the study.

You have problems with your memory and thinking abilities, as shown by a test called the Montreal Cognitive Assessment (MoCA) where you scored 23 or lower.

Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BE-FIT intervention or Health Education Control over 6 individual sessions delivered twice weekly during the initial weeks of outpatient cardiac rehabilitation

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for exercise adherence and anxiety reduction with assessments at baseline, end of treatment, and three follow-up points

18 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Exposure For Introceptive Tolerance
• Health Education Control

Trial Overview The BE-FIT program aims to reduce exercise anxiety through exposure therapy, stopping safety behaviors around exercise, and using a wrist activity monitor. It's being compared to standard health education in a randomized-controlled trial.

How Is the Trial Designed?

Group I: Behavioral Exposure For Introceptive Tolerance Experimental Treatment 1 Intervention

The BE-FIT intervention is a cognitive-behavioral intervention and is designed to target exercise anxiety. The three main components of BE-FIT include: 1) exposure to feared bodily sensations and exercise, 2) prevention of safety behavior use before/during/after exercise, and 3) use of a wrist-worn activity monitor (Fitbit) for PA feedback and activity goal setting.

Group II: Health Education Control Active Control 1 Intervention

HEC is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. In this arm, participants will be provided educational information about health topics relevant to healthy aging delivered through PowerPoint lectures and handouts and use a Fitbit for PA monitoring.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A brief group cognitive behavioral therapy combined with running as an interoceptive exposure was effective in reducing anxiety sensitivity levels in female undergraduates, particularly in those with high anxiety sensitivity.

The study found that decreases in cognitive and emotional reactions to running, rather than the physical sensations themselves, were linked to reduced anxiety sensitivity, indicating that changing how individuals think and feel about their sensations is key to the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Running as Interoceptive Exposure for Decreasing Anxiety Sensitivity: Replication and Extension. Sabourin, BC., Stewart, SH., Watt, MC., et al.[2018]

In a study involving 8 fibromyalgia patients, Cognitive Behavioral Treatment (CBT) showed improvements in pain catastrophizing, particularly with the imagined exposure technique, although no significant changes were observed in pain intensity or overall fibromyalgia impact.

The results indicate that while CBT can help reduce negative thought patterns related to pain, further research with larger groups is necessary to validate these findings and explore the effectiveness of imagined exposure in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imagined exposure as treatment of catastrophizing in fibromyalgia: a pilot study]. Rodero, B., García, J., Casanueva, B., et al.[2018]

A 15-week high-intensity aerobic exercise program significantly increased smoking abstinence rates among 150 adult smokers with high anxiety sensitivity, achieving a 27.6% abstinence rate compared to 14.8% in the control group.

Despite both groups showing a decline in anxiety sensitivity, the exercise program's effectiveness in promoting smoking cessation did not appear to be linked to changes in anxiety sensitivity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. Smits, JAJ., Zvolensky, MJ., Rosenfield, D., et al.[2023]

The study developed graded exposure (GEXP) virtual reality (VR) modules for individuals with chronic low back pain (cLBP) and high pain-related fear, showing that participants could safely engage in progressively challenging physical activities over three sessions.

Participants found the VR application to be feasible and acceptable, with no significant changes in pain or pain-related fear, indicating that they could complete the modules without exacerbating their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design. Hennessy, RW., Rumble, D., Christian, M., et al.[2020]

This scoping review analyzed 196 studies to explore how quantitative sensory testing can measure sensory changes related to physical activity in adults, highlighting its potential as a tool for assessing exercise-induced hypoalgesia.

The majority of studies focused on healthy adults and those with chronic conditions, primarily using pressure pain threshold measurements, indicating that physical activity can lead to significant neuromodulation effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Sensory Changes Related to Physical Activity in Adult Populations: A Scoping Review. Baehr, LA., Frey-Law, LA., Finley, M.[2023]

A study involving four chronic low back pain patients with significant fear of movement showed that graded exposure in vivo treatment was effective in reducing pain-related fears, catastrophizing, and pain disability, while usual graded activity did not lead to improvements.

Improvements in pain-related fear were associated with decreases in pain catastrophizing and disability, indicating that graded exposure can enhance pain control in patients with high fear of movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Vlaeyen, JW., de Jong, J., Geilen, M., et al.[2022]

A novel virtual reality exposure therapy program was tested on 13 patients with fibromyalgia syndrome, showing potential to alter pain catastrophizing related to exercise, which is crucial for improving exercise compliance.

Functional MRI results indicated that exercise visuals activated specific brain areas associated with pain processing in fibromyalgia patients, suggesting that this therapy could lead to neurophysiological changes that help manage pain perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting pain catastrophization in patients with fibromyalgia using virtual reality exposure therapy: a proof-of-concept study. Morris, LD., Louw, QA., Grimmer, KA., et al.[2020]

In a study of 77 patients with panic disorder and agoraphobia, adding moderate-intensity aerobic exercise before exposure-based cognitive behavioral therapy (eb-CBT) showed a trend towards greater symptom improvement compared to low-intensity exercise, particularly in anxiety levels as measured by the Hamilton Anxiety Rating Scale.

All patients experienced significant symptom relief after the treatment period, but the benefits of moderate-intensity exercise diminished at follow-up, suggesting that while it may accelerate initial improvements, lower-intensity exercise could lead to continued benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Running for extinction? Aerobic exercise as an augmentation of exposure therapy in panic disorder with agoraphobia. Bischoff, S., Wieder, G., Einsle, F., et al.[2022]

The BE-FIT intervention, a 6-session program designed to help patients with cardiovascular disease manage exercise sensitivity, was found to be safe and highly acceptable, with participants completing all sessions and reporting no adverse events.

Patients who underwent BE-FIT showed significant improvements in exercise sensitivity and increased physical activity levels, while the control group only experienced minimal changes, highlighting BE-FIT's potential efficacy in promoting physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be brave, BE-FIT! A pilot investigation of an ACT-informed exposure intervention to reduce exercise fear-avoidance in older adults. Farris, SG., Kibbey, MM.[2023]

The study identified four key types of interoceptive fears related to panic disorder: pseudoneurological, gastrointestinal, cardiorespiratory, and dissociative feelings, using the Body Sensations Questionnaire (BSQ) with a focus on interoceptive exposure exercises.

Specific interoceptive exposure tasks, such as hyperventilation and holding breath, were effective in significantly reducing pseudoneurological fears, indicating their potential utility in cognitive behavioral therapy for panic disorder, while highlighting the need for new tasks targeting cardiorespiratory and dissociative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness. Lee, K., Noda, Y., Nakano, Y., et al.[2023]

A 10-week mindfulness and acceptance-based intervention, using Acceptance and Commitment Therapy (ACT), showed high adherence rates (89.3% for walking and 85.5% for group sessions) among 24 sedentary adults, indicating its feasibility and acceptability.

Participants experienced significant improvements in cardiorespiratory fitness, evidenced by a large decrease in 1-mile walk test times and a moderate increase in estimated VO2max, alongside a substantial increase in exercise-related acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing of a mindfulness- and acceptance-based intervention for increasing cardiorespiratory fitness in sedentary adults: A feasibility study. Martin, EC., Galloway-Williams, N., Cox, MG., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39389421/

Behavioral Exposure for Interoceptive Tolerance (BE-FIT) The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002891

Behavioral Exposure for Interoceptive Tolerance (BE-FIT) The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at EOT and follow- ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05398276/behavioral-exposure-for-introceptive-tolerance-rct

Behavioral Exposure for Introceptive Tolerance RCT Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise ...

4. researchwithrutgers.com researchwithrutgers.com/en/publications/behavioral-exposure-for-interoceptive-tolerance-be-fit-a-stage-ii

Behavioral Exposure for Interoceptive Tolerance (BE-FIT) The third hypothesis is that reductions in exercise anxiety at EOT and Weeks 12 will mediate the effect of BE-FIT on activity outcomes at Weeks 18 and 24.

5. withpower.com withpower.com/trial/phase-2-exercise-sensitivity-4-2022-936db?lat=34.60184&lng=-117.81218

Behavioral Exposure Therapy for Exercise Intolerance Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/16506073.2022.2037017

Be brave, BE-FIT! A pilot investigation of an ACT-informed ... ... exercise sensitivity, called Behavioral Exposure For Interoceptive Tolerance (BE-FIT). ... data (and intolerance to uncertainty in the absence of such data).