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

(CPMH Trial)

Recruiting in Saint Louis (>99 mi)

Overseen By J. Phillip Miller, PhD

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

104 Participants Needed

Trial Summary

What is the purpose of this trial?

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.

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.

What data supports the effectiveness of the treatment Behavioral Activation + Medication for Depression & Anxiety in Aging Adults with Orthopedic Procedures?

Research shows that Behavioral Activation (BA) is effective in reducing depressive symptoms among older adults, including those in geriatric psychiatry settings and veterans in primary care. BA is a simple and accessible treatment that helps improve depression by encouraging engagement in positive activities. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for depression and anxiety in aging adults with orthopedic procedures?

Research shows that Behavioral Activation (BA) is effective in reducing depressive symptoms in older adults, including those in psychiatric facilities and primary care settings. BA is a simple and accessible treatment that helps improve mood by encouraging engagement in positive activities, making it a promising option for aging adults undergoing orthopedic procedures. ^{1 2 3 4 5}

How is the treatment for depression and anxiety in aging adults with orthopedic procedures unique?

This treatment combines Behavioral Activation (BA), which encourages engaging in activities to boost mood, with medication optimization, making it unique by addressing both behavioral and pharmacological aspects of depression and anxiety in older adults undergoing orthopedic procedures. ^{1 2 3 5 6}

How is the treatment Behavioral Activation + Medication for Depression & Anxiety in Aging Adults with Orthopedic Procedures different from other treatments?

This treatment is unique because it combines Behavioral Activation (BA), which focuses on increasing engagement in positive activities to improve mood, with medication optimization, specifically targeting aging adults undergoing orthopedic procedures. This dual approach addresses both psychological and physical aspects of recovery, which is not commonly seen in standard treatments for depression and anxiety in this population. ^{1 2 3 5 6}

Research Team

Ryan Calfee, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

References

1. England 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. [2021]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]