Behavioral Activation for Social Connectedness

Overseen By Renée L Pepin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Depression, Cognitive impairment, Hearing/vision, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults feel more socially connected through a six-session program called Brief Behavioral Activation, a type of therapy. The researchers seek to evaluate the effectiveness of this approach when delivered by staff from Area Agencies on Aging. It targets individuals over 60 who may feel isolated but do not have severe depression or cognitive issues. Participants should be able to use tele-conferencing tools and communicate in English. The study seeks to improve the sense of connection in older adults who might feel alone. As an unphased trial, it offers participants the chance to contribute to innovative research focused on enhancing social connections among older adults.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for older adults?

Research shows that Behavioral Activation, the treatment being tested, is generally easy for people to handle. Studies have found that this method can help reduce feelings of loneliness and depression in older adults and improve their social connections.

One study found that this treatment can also help people sleep better, although some reported feeling more stressed. It's important to know that this treatment is being explored for its benefits in enhancing social connections, not for treating medical conditions.

Overall, evidence suggests that Behavioral Activation is a safe choice for those looking to improve their social lives and mental well-being. However, if there are any concerns, discussing them with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Behavioral Activation for Improving Social Connectedness because it offers a novel way to enhance social ties through behavioral activation, which is a structured approach to increase engagement in meaningful activities. Unlike traditional treatments for social connectedness, which may include medications or lengthy therapy sessions, this approach is concise, comprising just six sessions. This method focuses on activating positive behaviors to improve social interaction, potentially offering quicker and more sustainable improvements in social connectedness.

What evidence suggests that this intervention is effective for improving social connectedness in older adults?

Research shows that Brief Behavioral Activation (BA), which participants in this trial will receive, can greatly enhance older adults' sense of connection with others. Studies have found that this method, particularly when conducted through video calls, has a lasting positive impact on reducing loneliness. For instance, one study discovered that the benefits of this approach can last for at least a year. Another study indicated that tailoring BA to emphasize social connections for older adults helps reduce feelings of isolation. Overall, these findings suggest that Brief Behavioral Activation is a promising way to help older adults feel more connected and engaged. ^{4 6 7 8 9}

Who Is on the Research Team?

Renée L Pepin, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults over 60 who are part of a home-delivered meals program and feel disconnected socially. It's not for those with significant depression, suicide risk, cognitive issues, severe hearing or vision problems that prevent using tele-conferencing tools, non-English speakers, people unable to consent, minors, pregnant women or prisoners.

Inclusion Criteria

Older adults (age>60) will be enrolled because they are the target population served by the home-delivered meals program and the target sample for this study.

Exclusion Criteria

Adults unable to consent will be excluded

Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS)

Cognitive Impairment (Blessed Orientation-Memory-Concentration Test>9)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-session Brief Behavioral Activation intervention to improve social connectedness

6 weeks

Follow-up

Participants are monitored for changes in social connectedness 12 weeks post-intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Activation for Improving Social Connectedness

Trial Overview The study tests a Brief Behavioral Activation technique aimed at improving social connections among seniors. The effectiveness will be measured by staff from the Area Agency on Aging who work with these individuals.

How Is the Trial Designed?

Group I: Brief Behavioral Activation for Improving Social Connectedness Experimental Treatment 1 Intervention

Active, 6 session Brief Behavioral Activation for Improving Social Connectedness

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

A modified version of Behavioral Activation, called Brief Behavioral Activation for Improving Social Connectedness, effectively reduced loneliness and depressive symptoms in homebound older adults, as shown in a recent randomized clinical trial.

The intervention, delivered over six weekly sessions by trained non-clinical individuals, shows promise for scalability in programs serving older adults, although further research is needed to confirm its long-term effectiveness and training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying Behavioral Activation to Reduce Social Isolation and Loneliness Among Older Adults. Pepin, R., Stevens, CJ., Choi, NG., et al.[2022]

A study involving 1139 participants from a larger trial found that 96% of respondents supported the use of SMS for monitoring vaccine safety after immunization, indicating a strong public acceptance of this method.

While most participants favored SMS surveillance, 62% believed that consent should be obtained beforehand, highlighting a need for addressing privacy concerns and understanding demographic factors that may affect compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Bednarz, J., et al.[2021]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

Social media discussions about adverse events (AEs) are increasing, but traditional data sources like the FDA's Adverse Event Reporting System (FAERS) show a greater increase in frequency, indicating that while social media can provide insights, it may not fully replace established pharmacovigilance methods.

The study found that linking posts from the same authors on social media resulted in higher quality medical insights, and actively engaging patients for follow-up information yielded a high response rate, suggesting that social media can enhance the depth of pharmacovigilance data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients via Online Healthcare Fora: Three Pharmacovigilance Use Cases. Powell, G., Kara, V., Painter, JL., et al.[2022]

Visualizing adverse events in clinical trials using methods like dot plots and volcano plots can enhance communication about the severity, timing, and recurrence of harms, rather than just counting occurrences.

The study analyzed individual participant data from a randomized trial of gabapentin for neuropathic pain, demonstrating that effective visualizations can help stakeholders better understand the multidimensional nature of harms in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. Qureshi, R., Chen, X., Goerg, C., et al.[2022]

The pilot testing of the cooperative card game 'Connections' showed that participants found it enjoyable and helpful in building social connections, with significant reductions in loneliness, depressed mood, and anxiety after playing.

Participants also reported increased enthusiasm for forming new connections and a greater willingness to open up to others, indicating the game's potential to enhance interpersonal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection. Van Bogart, K., Johnson, JA., Nayman, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286332/

One Year Impact on Social Connectedness for Homebound ... The one year outcomes indicate that brief BA delivered by tele-video conferencing can have an enduring impact on social connectedness.

2. ajgponline.org ajgponline.org/article/S1064-7481(20)30474-7/abstract

Modifying Behavioral Activation to Reduce Social Isolation ... Our preliminary research suggests that Behavioral Activation modified to address social connectedness in homebound older adults improves both social isolation ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748121003201

One Year Impact on Social Connectedness for ... The 1 year outcomes indicate that brief BA delivered by tele-video conferencing can have an enduring impact on social connectedness.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0305908

Engage! a pilot study of a brief behavioural activation program ... The Engage! study was a 6-week, online behavioral activation program to increase engagement and well-being in older adults, showing preliminary ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820098

Layperson-Delivered Telephone-Based Behavioral ... In the behavioral activation and mindfulness groups, sleep quality improved compared with befriending, but perceived stress increased.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722922001341

Behavioral Activation and Social Engagement for ... Linear mixed models showed decreases in social impairment, symptoms of PTSD and symptoms of depression, and increases in social connection and social support.

7. withpower.com withpower.com/trial/phase-social-connectedness-2023-cb2b8

Behavioral Activation for Social Connectedness Research shows that modifying Behavioral Activation can effectively reduce loneliness and increase social connectedness in older adults who are homebound. This ...

8. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(23)00238-6/fulltext

Behavioural activation to mitigate the psychological ... Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06239961

Behavioral Activation, Nutrition, and Activity Intervention This study aims to see if a 12-week program called Behavioral Activation (BA) can help people aged 50 and above with HIV by reducing loneliness and boosting ...