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

102 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Cognitive Behavior Therapy (CBT) and Social Navigation Group for loneliness?

Research shows that psychological treatments like Cognitive Behavioral Therapy (CBT) can significantly reduce loneliness, with studies finding a small to medium positive effect. Additionally, internet-based CBT has been effective in reducing loneliness and improving quality of life, suggesting that similar approaches could be beneficial. ^{1 2 3 4 5}

Is Therapy + Social Support for Loneliness safe for humans?

Therapy approaches like Cognitive Behavioral Therapy (CBT) and social support interventions have been studied for loneliness and other conditions, showing they are generally safe for humans. These interventions are often well-tolerated and considered feasible and acceptable by participants. ^{1 4 6 7 8}

How does the treatment of Cognitive Behavior Therapy (CBT) and Social Navigation Group for loneliness differ from other treatments?

This treatment is unique because it combines Cognitive Behavior Therapy (CBT), which helps change negative thought patterns, with a Social Navigation Group that provides social support, addressing both the mental and social aspects of loneliness. Unlike other treatments, this approach targets loneliness through both psychological and social interventions, potentially offering a more comprehensive solution. ^{2 4 9 10 11}

What is the purpose of this trial?

Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

Research Team

Sebastian Tong, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Reducing loneliness amongst older people: a systematic search and narrative review. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Reliability and validity of the 6-item UCLA Loneliness Scale(ULS-6)for application in adults]. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive Behavior Therapy for Loneliness: A Pilot Randomized Controlled Trial. [2020]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Interventions for reducing loneliness: An umbrella review of intervention studies. [2022]

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

Loneliness: clinical import and interventions. [2022]

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

Interventions for Loneliness Among Adult Cancer Survivors: A Systematic Review and Meta-Analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial. [2022]

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

The effects of the Unified Protocol and Unified Protocol skills on loneliness in the COVID-19 pandemic. [2023]

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

Effects of psychosocial group rehabilitation on health, use of health care services, and mortality of older persons suffering from loneliness: a randomized, controlled trial. [2018]