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

Trial Summary

What is the purpose of this trial?

Approximately 45% of older adults in the U.S. have 2 or more chronic health conditions (e.g., arthritis, hypertension, diabetes) in addition to functional limitations that prevent performance of health self-management activities. Self-management continues to be the gold standard for managing MCC, but functional limitations create difficulty with these activities (e.g., physical activity, symptom monitoring). Restricted self-management accelerates the downward spiral of disability and accumulating chronic conditions which, in turn, increases rates of institutionalization and death by 5-fold. Currently, there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations. Research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities, especially when contending with complex medical regimens and functional limitations. Combined with occupational therapy (OT), behavioral activation (BA) shows promise to improve health self-management in populations with chronic conditions and/or functional limitations. This innovative combination uses the goal setting, scheduling/monitoring activities, and problem-solving components of the BA approach as well as the environmental modification, activity adaptation, and focus on daily routines from OT practice. The investigators will test the effect of this combined approach in a Stage I, randomized controlled pilot feasibility study compared to enhanced usual care. The investigators will recruit 40 older adults with MCC and functional limitation and randomize 20 to the PI- delivered BA-OT protocol. This research will inform modification and larger-scale testing of this novel intervention and provide data for a federally funded career development award.

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 data supports the effectiveness of the treatment Behavioral Activation and Occupational Therapy for Multiple Chronic Conditions?

Research shows that Behavioral Activation (BA) is effective in reducing depressive symptoms and improving quality of life, especially among older adults and veterans. BA helps people engage in positive activities, which can be beneficial for managing depression and related conditions. ^{1 2 3 4 5}

Is Behavioral Activation and Occupational Therapy safe for humans?

There is no specific safety data available for Behavioral Activation and Occupational Therapy, but general safety concerns in medical treatments often include monitoring for adverse reactions and drug interactions, especially in older adults or those on multiple medications. ^{6 7 8 9 10}

How is the Behavioral Activation and Occupational Therapy treatment different from other treatments for multiple chronic conditions?

This treatment is unique because it combines Behavioral Activation, which encourages engaging in positive activities to improve mood, with Occupational Therapy, which focuses on helping people perform daily activities. This combination aims to address both emotional and functional aspects of living with multiple chronic conditions, offering a more holistic approach than treatments that focus solely on either mental health or physical rehabilitation. ^{4 5 11 12 13}

Research Team

Tara Klinedinst

Principal Investigator

University of Oklahoma

Eligibility Criteria

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 do not speak English.

I am currently receiving both occupational and physical therapy.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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 (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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of behavioral activation therapy with inpatient geriatric psychiatry patients. [2022]

2. United States 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. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. [2021]

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

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

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

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]

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

Principles of drug therapy in geriatric patients. [2013]

7. Germany pubmed.ncbi.nlm.nih.gov

Benefits, benefits, once more benefits... with no risk? Stop overlooking the harms of medicines. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Two Years of Active Pharmacovigilance Surveillance and Therapeutic Reconciliation in Frail Populations: The MEAP 3.0 Study. [2023]

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

Medication therapy management and complex patients with disability: a randomized controlled trial. [2014]

10. Belgium pubmed.ncbi.nlm.nih.gov

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

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

What is behavioral activation? A review of the empirical literature. [2022]

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

Behavioral activation therapy for remediating persistent social deficits in medication-responsive chronic depression. [2011]

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

An interdisciplinary behavioral treatment program for depressed geriatric rehabilitation inpatients. [2019]