Therapy + Social Support for Loneliness

(DLoop Trial)

Overseen By Ajla Pleho

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Opioids

Disqualifiers: Cancer pain, Palliative care, Surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether reducing loneliness can help individuals on long-term opioids use these medications more safely. It tests two approaches: Cognitive Behavioral Therapy (CBT), which involves discussing thoughts and feelings to enhance mental well-being, and a Social Navigation Group, which aids in connecting with others. Participants will be divided into groups to try one of these treatments or continue with their usual care. Ideal participants speak English, have been on prescribed opioids for over three months, feel lonely, and have a chronic pain diagnosis.

As an unphased trial, this study provides a unique opportunity to explore new methods for improving well-being and managing opioid use safely.

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

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be on chronic opioids, so you may need to continue those medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for most people. Past studies demonstrated that CBT helps change negative thinking patterns without causing harm. It is usually well-tolerated, with few reports of side effects.

For the Social Navigation Group, studies indicate that increasing social connections is safe and beneficial for health. Social support can boost mental well-being and reduce loneliness. No evidence suggests harm from participating in social support activities.

Both treatments aim to improve mental health and social connections, and they have been shown to be safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to tackle loneliness with a focus on mental and social aspects. Cognitive Behavioral Therapy (CBT) is unique because it helps participants change negative thought patterns through structured one-hour Zoom sessions over eight weeks, which is a flexible and accessible delivery method. The Social Navigation Group stands out by providing a supportive environment in shorter, 30-minute Zoom sessions, fostering social skills and connections. Unlike the usual care that might not directly address loneliness, these methods are designed to actively engage participants in overcoming feelings of isolation.

What evidence suggests that this trial's treatments could be effective for reducing loneliness and opioid misuse?

This trial will compare Cognitive Behavioral Therapy (CBT) and the Social Navigation Group as interventions for loneliness. Research has shown that CBT, which participants in this trial may receive, can help reduce feelings of loneliness. One study found that shorter group sessions of CBT significantly decreased loneliness, suggesting that CBT might help people feel less alone.

The Social Navigation Group, another treatment option in this trial, is supported by evidence for its role in improving social connections. A study involving peer support found that participants felt less lonely and faced fewer obstacles to socializing. This approach aims to boost mental wellness by helping people connect better with others. ^{1 6 7 8 9}

Who Is on the Research Team?

Sebastian Tong, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for individuals feeling lonely and dealing with opioid use disorder, who are currently on long-term opioid treatment in primary care settings. The study aims to see if addressing loneliness can help reduce opioid misuse.

Inclusion Criteria

English-speaking

I have been diagnosed with chronic pain.

I have been on prescribed opioids for 3 or more months.

Exclusion Criteria

Severe cognitive impairment or active psychosis

I experience pain due to my cancer.

I am receiving palliative care or live in a controlled setting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioral Therapy (CBT), Social Navigation, or Usual Care for 8 weeks

8 weeks

Weekly sessions via Zoom

Follow-up

Participants are monitored for changes in opioid misuse, functional outcomes, and loneliness

3 months

Post-intervention assessment at 2 weeks and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavior Therapy (CBT)
• Social Navigation Group

Trial Overview The study is testing two approaches: Cognitive Behavior Therapy (CBT), which is a type of talk therapy, and Social Navigation Group activities designed to improve social connections. Participants will be compared with a control group that does not receive these interventions.

How Is the Trial Designed?

Group I: Usual Care Group Experimental Treatment 1 Intervention

Participants will be randomized to the usual care group (N=34). Participants in this group will resume to their usual standard of care for 8 weeks.

Group II: Social Navigation Group Experimental Treatment 1 Intervention

Participants will be randomized to the social navigation group (N=34). Social navigation group will meet for 30 mins via Zoom, for 8 weeks.

Group III: Cognitive Behavioral Therapy (CBT) Experimental Treatment 1 Intervention

Participants will be randomized to the CBT group (N=34). CBT groups will meet for 1 hour via Zoom, for 8 weeks.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Home-based interventions significantly improve social connectedness and reduce loneliness and depressive symptoms among older adults, based on a meta-analysis of 14 randomized controlled trials.

Interventions lasting more than three months and delivered through mixed platforms (like online and in-person) were particularly effective, suggesting that the format and duration of these programs are important for their success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based interventions in improving loneliness and social connectedness among older adults: a systematic review and meta-analysis. Chua, CMS., Chua, JYX., Shorey, S.[2023]

An umbrella review of 211 studies identified three effective interventions for reducing loneliness: meditation/mindfulness, social cognitive training, and social support, with varying degrees of statistical significance.

Despite these findings, the evidence supporting these interventions is rated as low to very low, highlighting the need for more large-scale randomized controlled trials to confirm their efficacy in reducing loneliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for reducing loneliness: An umbrella review of intervention studies. Veronese, N., Galvano, D., D'Antiga, F., et al.[2022]

A literature review of 17 studies found that recent social therapeutic interventions, particularly those involving new technologies, significantly reduced loneliness in older adults.

Group work interventions also showed effectiveness in decreasing loneliness, highlighting the potential of both technological and social approaches in supporting older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing loneliness amongst older people: a systematic search and narrative review. Hagan, R., Manktelow, R., Taylor, BJ., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494325003103

Review The Effectiveness of Cognitive Behavioral Therapy ... CBT shows exploratory evidence of reducing loneliness among older adults. · Shorter durations and group formats showed stronger effects. · Online ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9811092/

Can we mitigate the psychological impacts of social ... There were few long-term trials, but there was evidence of some benefit (loneliness SMD=−0.20, 95% CI −0.40 to −0.01; depression SMD=−0.20, 95% CI −0.47 to 0.07) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33100187/

A Secondary Analysis of a Randomized Controlled Trial Conclusions: CBT programs for depression and anxiety are likely to be effective at reducing loneliness. This may be due to shared underlying ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735821001094

Review The effectiveness of psychological interventions for ... 28 studies (N = 3039) were included in a meta-analysis which found that psychological interventions significantly reduced loneliness compared to control groups, ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-17097-2

What works in interventions targeting loneliness: a systematic ... The study utilising cognitive behavioural therapy (CBT) principles [33] showed a significant reduction in loneliness for the entire sample, both ...

6. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1433108/full

Developing a brief telematic cognitive behavioral therapy ... The present study aims to present a novel cognitive-behavioral intervention protocol focused on treating social isolation through telematic interaction.

7. publichealth.tulane.edu publichealth.tulane.edu/blog/effects-of-social-isolation-on-mental-health/

Understanding the Effects of Social Isolation on Mental ... Social isolation has been linked to heightened risks of depression, anxiety, and cognitive decline.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

9. apa.org apa.org/monitor/2019/05/ce-corner-isolation

The risks of social isolation Lack of social connection heightens health risks as much as smoking 15 cigarettes a day or having alcohol use disorder.