NCT06285032

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 9, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

February 13, 2024

Last Update Submit

January 8, 2026

Conditions

LonelinessOpioid Use

Keywords

LonelinessOpioid useChronic pain

Outcome Measures

Primary Outcomes (1)

  • Opioid Misuse

    The primary outcome is to see changes in opioid misuse, which the investigators will measure using the Current Opioid Misuse Measure (COMM). The investigators will give the COMM at baseline, post-intervention (2 weeks after intervention completion), and 3 months after the intervention has been completed to find out changes in behaviors. Those with a score of 9 or greater are consider positive for misuse (min=0, max score=68).

    Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.

Secondary Outcomes (1)

  • Determine Functional Outcome

    Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.

Other Outcomes (1)

  • Loneliness

    Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.

Study Arms (3)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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

Behavioral: Cognitive Behavior Therapy (CBT)

Social Navigation Group

EXPERIMENTAL

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

Behavioral: Social Navigation Group

Usual Care Group

EXPERIMENTAL

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.

Behavioral: Controlled Group

Interventions

Cognitive Behavior Therapy (CBT)BEHAVIORAL

Individuals will participate in a series of eight, 1hour weekly group sessions delivered by a study interventionalist who is a licensed social worker (see personnel list) using a HIPAA-compliant videoconferencing platform (Zoom). Each group will consist of 6-10 participants and participants randomized to this intervention will select between a series of date/time options. The investigators plan to run four groups with staggered start times. All participants will receive digital copies of the workbook for this intervention and each session, they will be given assignments to practice the strategies they learn during the intervention.

Also known as: CBT
Cognitive Behavioral Therapy (CBT)
Social Navigation GroupBEHAVIORAL

Those in the social navigation intervention, will meet with a navigator weekly through a virtual visit (HIPAA-compliant videoconferencing or phone call based on patient preference) over the course of 8 weeks. Each virtual visit will last approximately 30 minutes with a longer initial intake visit lasting 60 minutes. During the intake visit, the navigator will complete a patient narrative and an inventory of the patient's existing social network, former social network and interests. Using this, the navigator will work with the patient to develop an action plan to promote, establish or re-establish social connections. The action plan will be referenced and refined throughout the course of the 8 weeks. They will suggest specific social activities and connect patients to resources such as, community-based organizations or local social groups matched to individual participant interest to assist with social connection

Social Navigation Group
Controlled GroupBEHAVIORAL

Those randomized to the control group will receive usual care from their primary care clinician. At the conclusion of the study (after the final outcomes are collected), they will be offered a list of possible community-based organizations for social connection.

Usual Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • English-speaking
  • On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids \[functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies\])
  • With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale
  • Have a chronic pain diagnosis

You may not qualify if:

  • Have cancer-related pain
  • Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
  • Have an upcoming scheduled surgery
  • Severe cognitive impairment or active psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Tong ST, Ma KPK, Pleho A, Keiser B, Hsu C, Ehde DM, Curran MC, Tsui JI, Raue PJ, Stephens KA. Comparing cognitive behavioral therapy and social prescribing in patients with loneliness on long-term opioid therapy to reduce opioid misuse: protocol for a randomized controlled trial. Addict Sci Clin Pract. 2024 Sep 11;19(1):66. doi: 10.1186/s13722-024-00498-y.

    PMID: 39261953DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sebastian Tong, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor: School of Family Medicine

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 29, 2024

Study Start

August 9, 2024

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)