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Behavioral Intervention

Cognitive Behavioral Therapy for Chronic Pain and Loneliness

Phase 1

Waitlist Available

Led By Lisham Ashrafioun, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 18 years of age or older

Score at least 4 (of 10) on each of the three items on the PEG (Pain intensity, and Pain interference in Enjoying activities and General activities)

Must not have

Have significant unstable or uncontrolled medical conditions, including cancer requiring ongoing oncology treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1-month post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether loneliness is a stressor associated with chronic pain, and whether cognitive behavioral therapy for loneliness can help.

Who is the study for?

This trial is for English-speaking adults over 18 who often feel pain and loneliness. They must have chronic pain most days for the past six months, score high on a pain scale, and feel lonely based on a specific test. Participants need phone or computer access but can't join if they don't understand consent, are planning surgery soon, have unstable medical conditions like active cancer treatment, or severe substance use issues.

What is being tested?

The study tests two types of Cognitive Behavioral Therapy (CBT): one targeting loneliness (CBT-L) and another focusing on managing chronic pain. After an initial small-scale test of CBT-L in veterans with chronic pain feeling lonely, participants will be randomly assigned to either CBT-L or standard CBT for Chronic Pain to compare effects on social interactions and how much their pain affects them.

What are the potential side effects?

Since this trial involves therapy sessions rather than medication, typical side effects associated with drugs aren’t expected. However, discussing painful emotions could temporarily increase distress or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My pain score is 4 or more, affecting my enjoyment and daily activities.

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I speak English.

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I have experienced pain on most days for the last six months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled medical conditions or cancer needing ongoing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1-month post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1-month post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1-month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in loneliness

Mean change in pain interference

Secondary study objectives

Mean change in fear of pain

Mean change in social interactions

Other study objectives

Mean change in anxiety

Mean change in depression

Mean change in pain catastrophizing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT for LonelinessExperimental Treatment1 Intervention

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.

Group II: CBT for Chronic PainActive Control1 Intervention

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT for Loneliness

2023

Completed Phase 1

~50

0 / 5Eligibility criteria met