Behavioral Activation and Occupational Therapy for Multiple Chronic Conditions

(BA+OT Trial)

Overseen By Tara Klinedinst, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Cancer, Neurological, Mental illness, others

Compensation: Varies

Number of Visits: 12

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining Behavioral Activation (planning and doing daily activities) and Occupational Therapy (adapting activities and environments) can help older adults better manage their health. It focuses on individuals with at least two chronic health conditions, such as arthritis or diabetes, who face difficulties with daily tasks. Participants will collaborate with a therapist over 10 sessions to set goals, improve routines, and increase physical activity, using tools like a Fitbit. This trial suits those living near the University of Oklahoma who wish to set and achieve at least one physical activity goal. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative research aimed at enhancing daily life for those with chronic conditions.

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 focuses on behavioral and occupational therapy, so it's best to discuss your medications with the trial team.

What prior data suggests that this Behavioral Activation and Occupational Therapy protocol is safe for older adults with multiple chronic conditions?

Earlier research has shown that combining Behavioral Activation (BA) with Occupational Therapy (OT) may help manage several long-term health issues. However, specific safety information for this combination is not available.

Safety concerns in medical treatments typically involve side effects, but BA and OT are not drug-based. They focus on improving daily habits and actions, which generally makes them safe. This trial, in its early stages, primarily aims to assess the treatment's effectiveness rather than its safety.

For those considering participation, it may be reassuring to know that BA and OT are widely used in healthcare and have been safely applied in many situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Behavioral Activation and Occupational Therapy for managing multiple chronic conditions because it integrates mental health and daily activity planning. Unlike traditional treatments that may focus solely on medication or individual therapy, this approach empowers patients by setting personalized goals and building daily routines, directly in their home environment. This hands-on, personalized approach, supported by tools like the Fitbit for self-monitoring physical activity, aims to enhance patient engagement and potentially improve overall health outcomes.

What evidence suggests that the Behavioral Activation and Occupational Therapy intervention could be effective for managing multiple chronic conditions?

This trial will compare the effectiveness of two approaches for managing multiple chronic conditions. One group of participants will receive a combination of Behavioral Activation (BA) and Occupational Therapy (OT). Research has shown that combining BA with OT can help older adults manage their health better. Studies indicate that BA can lower depression and improve quality of life, particularly for older adults. When paired with OT, this method can enhance daily routines and help people follow their health plans. Early evidence suggests that this combination aids in handling multiple chronic conditions by increasing independence in everyday activities.

Another group in this trial will receive Enhanced Usual Care, which includes assessments, a Fitbit Charge 5 with training, and a handout about living with chronic conditions. This approach serves as a control to evaluate the effectiveness of the BA+OT intervention. ^{1 2 3 4 5}

Who Is on the Research Team?

Tara Klinedinst

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for older adults living near the University of Oklahoma who have at least two chronic conditions like arthritis or diabetes, and also have a functional limitation. They must be willing to set a physical activity goal but cannot be in other therapy treatments, have severe mental illness, cognitive impairments, progressive neurological conditions, or a short life expectancy.

Inclusion Criteria

Intention to set at least 1 physical activity goal

I have at least one physical limitation.

At least 2 chronic conditions

Exclusion Criteria

Current or history of severe mental illness

I am currently receiving both occupational and physical therapy.

My neurological condition is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BA-OT intervention, which includes goal setting, scheduling/monitoring activities, and problem-solving components delivered over 10 weeks

10 weeks

10 sessions (in-person, at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 10 and 22 weeks

12 weeks

2 follow-up assessments (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation + Occupational Therapy
• Enhanced Usual Care

Trial Overview The study is testing an innovative approach combining Behavioral Activation with Occupational Therapy against enhanced usual care. It aims to help older adults manage multiple chronic conditions by planning health-promoting activities and adapting their environment.

How Is the Trial Designed?

Group I: BA+OT intervention Experimental Treatment 1 Intervention

Following baseline assessment, the PI, a BA-trained, licensed occupational therapist will deliver a 10-session manualized program in the participants' homes to ensure optimal uptake of the active ingredients and integration into daily life routines. This intervention occurs over 10 weeks. The intervention manual will include educational materials for the 4-step approach, and worksheets for goal setting and developing daily routines. In the 1st BA-OT session, the PI will collect baseline assessments and use Canadian Occupational Performance Measure (COPM) data to facilitate goal setting. The top 5 participant-selected goals chosen will be the subject of the 4-step process in sessions 2 - 10. At least one goal must be related to improving physical activity routines; each participant will receive a Fitbit Charge 5 to self-monitor fitness progress. The unbiased evaluator will carry out follow-up assessments at 10 weeks and 22 weeks with participants in both conditions.

Group II: Enhanced Usual Care Placebo Group 1 Intervention

The enhanced usual care control group will receive the same assessment battery, a Fitbit Charge 5 with 1 hour training, and a handout about living with chronic conditions.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Presbyterian Health Foundation

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

Behavioral activation (BA) is an effective treatment for depression that focuses on increasing positive reinforcement in the environment to promote healthy behaviors and reduce avoidance.

BA can be integrated with other cognitive-behavioral strategies, making it versatile for various clinical populations and settings, highlighting its potential for broader application in treating emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. Farchione, TJ., Boswell, JF., Wilner, JG.[2019]

Behavioral Activation (BA) treatment significantly reduced depressive symptoms in older adults with mild to moderate cognitive impairment, based on a study of 50 participants over 4 weeks.

The study found no significant impact of BA on quality of life, indicating that while it helps with depression, it may not improve overall life satisfaction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of behavioral activation therapy with inpatient geriatric psychiatry patients. Snarski, M., Scogin, F., DiNapoli, E., et al.[2022]

A study involving adults aged 40 and older with activity limitations found that a modified medication therapy management (MTM) program combined with a self-efficacy workshop did not significantly reduce symptom burden compared to usual care or the workshop alone.

Participants in the MTM group reported more adverse drug events (ADEs) and had more changes in their medication regimens, suggesting that while the program increased medication management, it did not lead to improved health outcomes for symptom burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication therapy management and complex patients with disability: a randomized controlled trial. Chrischilles, EA., Doucette, W., Farris, K., et al.[2014]

Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its potential as a treatment for vulnerable populations.

Interestingly, the specific types or amounts of activities (functional, pleasurable, or social) did not significantly correlate with symptom improvement, suggesting that simply engaging in activities to counter avoidance may be key to the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. Hershenberg, R., Paulson, D., Gros, DF., et al.[2015]

An innovative interdisciplinary behavioral treatment protocol for depression was developed, where occupational therapists were trained to implement specific behavioral techniques during therapy sessions.

Early results suggest that this treatment can be delivered reliably and accurately, potentially improving functional independence for individuals with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interdisciplinary behavioral treatment program for depressed geriatric rehabilitation inpatients. Lichtenberg, PA., Kimbarow, ML., MacKinnon, D., et al.[2019]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

The MEAP 3.0 study analyzed 2977 reports of adverse drug reactions (ADRs) and found that 'anti-infectives for systemic use' and 'cardiovascular system' drugs were the most common culprits for ADRs in patients under 18 and over 65, respectively.

The study identified 2179 drug-drug interactions (DDIs), with 10.7% linked to ADRs, highlighting the importance of pharmacovigilance and therapeutic reconciliation to prevent these interactions and enhance personalized medicine in frail populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Years of Active Pharmacovigilance Surveillance and Therapeutic Reconciliation in Frail Populations: The MEAP 3.0 Study. Bombelli, A., Guarnieri, G., Lombardi, N., et al.[2023]

A brief version of Behavioral Activation for primary care (BA-PC) was found to significantly improve quality of life and mental health functioning in veterans compared to standard treatment-as-usual (TAU) after 12 weeks, despite both groups showing reductions in depressive symptoms.

The study involved 140 veterans and demonstrated that BA-PC not only maintained reductions in depressive symptoms but also had better treatment retention and feasibility, suggesting it could be a valuable approach for managing depression in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. Funderburk, JS., Pigeon, WR., Shepardson, RL., et al.[2021]

Drug approval processes primarily focus on efficacy, often leading to an overestimation of benefits while safety assessments are largely deferred to post-marketing studies, which can result in insufficient understanding of real-world effectiveness and potential harms.

There is a critical need for independent research on drug toxicity, especially regarding polypharmacy in older adults, as the interactions and long-term effects of multiple medications are not well understood, highlighting the importance of ongoing evaluation of the benefit-harm profile of drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits, benefits, once more benefits... with no risk? Stop overlooking the harms of medicines. Garattini, S., Bertele', V.[2018]

Polypharmacy, especially in patients over 70, can lead to increased adverse drug reactions and medication errors due to drug-drug interactions and poor compliance, highlighting the need for careful medication management.

Preventive measures, such as conducting appropriate clinical trials and improving reporting systems for adverse drug reactions, are essential to enhance safety and reduce risks associated with polytherapy in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pitfalls of polypharmacy, particularly in the elderly]. Queneau, P.[2015]

Behavioral activation therapy is a promising adjunct treatment for patients with medication-responsive chronic depression who still face social and occupational challenges, as medication alone often does not fully address these issues.

Preliminary evidence indicates that behavioral activation therapy can be effectively adapted for these patients, requiring minimal modifications to help improve their social and occupational functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for remediating persistent social deficits in medication-responsive chronic depression. Erickson, G., Hellerstein, DJ.[2011]

Elderly individuals (over 65 years) make up 12% of the U.S. population but account for 33% of all prescription drug use, highlighting their significant medication consumption.

The risk of adverse drug reactions is notably higher in the elderly due to factors like decreased organ function, changes in how drugs are processed in the body, and the complexities of taking multiple medications (polypharmacy), emphasizing the need for careful management of their drug regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of drug therapy in geriatric patients. Sloan, RW.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998403/

A pilot, randomized, feasibility study to improve health self ... Our team asserts that combining occupational therapy (OT) and behavioral activation (BA) shows promise to improve health self-management in populations with ...

2. clinicaltrial.be clinicaltrial.be/en/details/78718?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Behavioral Activation + Occupational Therapy: An Innovati... Behavioral activation (BA), an evidence-based behavior change intervention, can improve performance in daily activity, including health self- ...

3. trialx.com trialx.com/clinical-trials/listings/242835/behavioral-activation-occupational-therapy-an-innovative-intervention-for-empowered-self-management-of-multiple-chronic-conditions/

Behavioral Activation + Occupational Therapy: An ... Combined with occupational therapy (OT), behavioral activation (BA) shows promise to improve health self-management in populations with chronic ...

4. withpower.com withpower.com/trial/phase-multiple-chronic-conditions-10-2022-1a1dc

Behavioral Activation and Occupational Therapy for ... Research shows that Behavioral Activation (BA) is effective in reducing depressive symptoms and improving quality of life, especially among older adults and ...

5. healthpromotionresearch.org healthpromotionresearch.org/Studies/behavioral-activation-occupational-therapy-an-innovative-intervention-for-empowered-self-management-of-multiple-chronic-conditions

Behavioral Activation + Occupational Therapy The aims of this project are to: 1) collect preliminary data to test the effect of behavioral activation + occupational therapy (BA-OT) for...