LonelinessDLoopNCT06285032
Decreasing Loneliness to Optimize Pain Care
A study testing Cognitive Behavior Therapy (CBT) and Social Navigation Group in people with Loneliness and Opioid Use, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Opioid Use
- What is being tested?
- Cognitive Behavior Therapy (CBT) and Social Navigation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse
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.
Read the detailed description
Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder.
Aims
- To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
- To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
- To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.
- Conditions
- Loneliness, Opioid Use
- Being tested
- Cognitive Behavior Therapy (CBT), Social Navigation Group, Controlled Group
- Keywords
- Loneliness, Opioid use, Chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy (CBT)Behavioural
Also called CBT
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.
Social Navigation GroupBehavioural
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
Controlled GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Controlled Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Secondary outcomes (1)
Determine Functional Outcome
The investigators will use the Patient Reported Outcomes Measurement Information (PROMIS) pain interference (version 6b) to measure changes in functionality. Investigators will interpret data from the survey and look at participants who indicate any amount of pain (min=0, max score=30). The PROMIS scale is used to track pain interference, especially for those who frequently struggle with chronic pain and therefore, are on chronic opioids.
Measured: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start9 Aug 2024
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sebastian Tong, University of Washington
- Investigators
- Sebastian Tong, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285032
- Sponsor's protocol ID
- STUDY00017244
- Other IDs
- R34DA058325
- Acronym
- DLoop
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39261953
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse
- ClinicalTrials.gov ID
- NCT06285032
- Acronym / sponsor ID
- DLoop / STUDY00017244
- Conditions
- Loneliness, Opioid Use
- Keywords
- Loneliness, Opioid use, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder.
Aims
- To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
- To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
- To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavior Therapy (CBT)Participants will be randomized to the CBT group (N=34). CBT groups will meet for 1 hour via Zoom, for 8 weeks. |
| Social Navigation Group | Experimental | Behavioral: Social Navigation GroupParticipants will be randomized to the social navigation group (N=34). Social navigation group will meet for 30 mins via Zoom, for 8 weeks. |
| Usual Care Group | Experimental | Behavioral: Controlled GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy (CBT)Also: CBTIndividuals 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. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Social Navigation GroupThose 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 | Behavioural | Social Navigation Group |
| Controlled GroupThose 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. | Behavioural | Usual Care Group |
Primary outcome
Opioid Misuse
Time frame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
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).
1 secondary outcome
Determine Functional Outcome
Time frame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 39261953Tong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Tong, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy (CBT) and Social Navigation Group in people with Loneliness and Opioid Use, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Misuse (time frame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.