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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1-month post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in loneliness
Mean change in pain interference
Secondary outcome measures
Mean change in fear of pain
Mean change in social interactions
Other outcome measures
Mean change in anxiety
Mean change in depression
Mean change in pain catastrophizing
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,405 Total Patients Enrolled
39 Trials studying Chronic Pain
4,709 Patients Enrolled for Chronic Pain
Lisham Ashrafioun, PhDPrincipal InvestigatorVA Finger Lakes Healthcare System, Canandaigua, NY
2 Previous Clinical Trials
336 Total Patients Enrolled
1 Trials studying Chronic Pain
300 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently struggling with a serious drug or alcohol addiction.I am 18 years old or older.My pain score is 4 or more, affecting my enjoyment and daily activities.I speak English.I do not have any uncontrolled medical conditions or cancer needing ongoing treatment.I have experienced pain on most days for the last six months or more.You have a high score on a test for feeling lonely.I have had surgery recently or will have one soon.
Research Study Groups:
This trial has the following groups:- Group 1: CBT for Chronic Pain
- Group 2: CBT for Loneliness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants sought for this experiment currently?
"According to the listings available on clinicaltrials.gov, this medical study is not currently enrolling volunteers. The trial was initially posted in December of 2022 and last updated five months later, but there are more than 400 studies actively recruiting at present."
Answered by AI
Could CBT pose a hazard to individuals struggling with loneliness?
"Our team has assigned Cognitive Behavioural Therapy for Loneliness a score of 1, as the trial is currently in Phase 1 and thus lacks robust data to validate its safety."
Answered by AI
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