Behavioral Activation + Medication for Depression & Anxiety in Aging Adults with Orthopedic Procedures

(CPMH Trial)

No longer recruiting at 1 trial location

Overseen By Michael S Avidan, MBBch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Severe cognitive impairment, Acutely suicidal, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how combining behavioral activation therapy with medication adjustments can reduce depression and anxiety in older adults undergoing hip or knee surgery. Participants will either receive this new combined treatment or continue with their usual care. Those who might be a good fit have significant anxiety or depression and are scheduled for hip or knee replacement surgery.

As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve mental health care for surgical patients.

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.

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 is 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 shows that behavioral activation is a proven and safe way to treat depression. It effectively reduces symptoms in older adults, even those with some memory or thinking issues. This method encourages activities that increase positive experiences, improving mood and lessening depression.

Regarding medication, research indicates that adjusting medications for older adults can enhance safety and effectiveness. This involves reducing drugs that might harm the brain and ensuring appropriate doses of antidepressants and other mental health medications. Studies have shown that careful medication management can improve the quality of life for older adults, especially around surgery times, by reducing anxiety and depression.

In summary, both behavioral activation and careful medication management have been well-received in studies with older adults. They show promise in safely reducing symptoms of depression and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of behavioral activation and medication optimization for treating depression and anxiety in aging adults undergoing orthopedic procedures. Unlike standard treatments, which often focus solely on medications or therapy, this approach integrates both. Behavioral activation helps patients engage in meaningful activities to improve mood, starting right around the time of surgery and continuing for three months. Meanwhile, medication optimization ensures patients receive the best possible mental health care by minimizing brain-toxic drugs and fine-tuning antidepressant doses. This dual approach aims to enhance recovery and mental well-being more effectively than traditional methods alone.

What evidence suggests that this trial's treatments could be effective for depression and anxiety in aging adults undergoing orthopedic procedures?

Research shows that behavioral activation, which participants in this trial may receive, can help reduce depression in older adults. Studies indicate it can significantly decrease depressive symptoms and encourage healthier habits. It has proven as effective as antidepressant medication for those with more severe depression.

In this trial, some participants will receive behavioral activation alongside medication optimization. Research emphasizes the need to adjust mental health drugs, especially before surgery. Adjusting antidepressant doses and reducing medications that affect the brain can help lessen anxiety and depression, which often lead to poor surgical outcomes. Together, these treatments aim to improve mental health in older adults undergoing orthopedic surgery. Meanwhile, participants in the control arm will continue with usual care, receiving printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults. ^{1 2 4 6 7}

Who Is on the Research Team?

Ryan Calfee, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who are about to have hip or knee replacement surgery and are experiencing noticeable symptoms of depression or anxiety. They must be able to communicate in English. Those with severe cognitive issues, a history of similar study participation, or acute suicidal thoughts cannot join.

Inclusion Criteria

PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

I am 60 years old or older.

I am scheduled for a first-time hip or knee replacement surgery.

Exclusion Criteria

Barrier to communication (Unable to read, speak, and understand English)

Severe cognitive impairment screened by the SBT (Short Blessed Test) >10

Acutely suicidal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Behavioral activation and medication optimization begin perioperatively

1 week

1 visit (in-person)

Postoperative Treatment

Behavioral activation and medication optimization continue for 3 months postoperatively

12 weeks

Weekly or biweekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral activation
• Care as usual
• Medication optimization

Trial Overview

The study is examining the impact of combining behavioral activation (a therapy focusing on increasing engagement in valued activities) with medication adjustments versus usual care on reducing depression and anxiety in aging adults during orthopedic surgery recovery.

How Is the Trial Designed?

Group I: Control (treatment as usual) Experimental Treatment 1 Intervention

Participants in control arm will continue care as usual. They will receive printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults.

Group II: Behavioral activation and medication optimization Experimental Treatment 2 Interventions

Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

This study aims to evaluate the effectiveness of Behavioral Activation (BA) as a nursing intervention for elderly patients with Major Depressive Disorder (MDD) in inpatient settings, marking the first research of its kind in this population.

The trial will include 102 participants across ten mental health care units in the Netherlands, comparing BA to Treatment as Usual (TAU) over an eight-week period, with depression levels assessed using the Beck Depression Inventory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systematic activation method as a nursing intervention in depressed elderly: a protocol for a multi-centre cluster randomized trial. Clignet, F., van Meijel, B., van Straten, A., et al.[2021]

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 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]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

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) 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]

Citations

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