Chronic PainNCT03982433
Internet-based Videoconferencing to Address Alcohol Use and Pain
A study testing Motivation and Cognitive Behavioral Management for Alcohol and Pain in people with Chronic Pain and Alcohol Use, Unspecified, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Alcohol Use, Unspecified
- What is being tested?
- Motivation and Cognitive Behavioral Management for Alcohol and Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the Brief Pain Inventory (BPI) non-cancer related pain.
Who cannot join
- psychoactive medication for pain or alcohol use for few than 2 months
- history of bipolar disorder, schizophrenia, other psychotic disorder
- current suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- current behavioral treatment for pain or alcohol use
- any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Unit, Boston University
Boston, Massachusetts, 02215
About this study
Official title: Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.
Read the detailed description
This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.
- Conditions
- Chronic Pain, Alcohol Use, Unspecified
- Being tested
- Motivation and Cognitive Behavioral Management for Alcohol and Pain
- Keywords
- HIV
- Medical subject headings
- Chronic Pain, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation and Cognitive Behavioral Management for Alcohol and PainBehavioural
Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | participants all receive the intervention Receives: Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory Pain Severity
BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.
Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10
Measured: past 7 days
Brief Pain Inventory Pain Interference
BPI consists of 11-point scale items that reflect pain severity and pain interference
Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10
Measured: past 7 days
Alcohol Time Line Follow Back...Heavy Drinking Episodes
number of heavy drinking episodes in the past 30 days
Measured: past 30 days
Alcohol Time Line Follow Back...Average Drinks Per Week
average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)
Measured: past 30 days
Client Satisfaction Questionnaire-8 [Modified]
Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.
The possible range of scores is 8-32.
Measured: past 30 days
Perceptions of Treatment Questionnaire
Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.
Measured: past 30 days
Secondary outcomes (2)
Goal Systems Assessment Battery-Pain
Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.
Measured: past 30 days
Goal Systems Assessment Battery-Alcohol
Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.
Measured: past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Mar 2019
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants all undergo assessment and intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Tibor P Palfai, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982433
- Sponsor's protocol ID
- 4546
- Other IDs
- UH2AA026192
- Status last verified
- Nov 2019
- First submitted
- 14 May 2019
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palfai TP, Kratzer MPL, Taylor JL, Otis JD, Winter MR. Addressing Pain and Heavy Drinking among Patients in HIV-Care: A Pilot Study of an Integrated Telehealth Intervention. AIDS Behav. 2025 Jun;29(6):1930-1943. doi: 10.1007/s10461-025-04660-8. Epub 2025 Feb 25.
PubMed 39998790
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
- ClinicalTrials.gov ID
- NCT03982433
- Acronym / sponsor ID
- 4546
- Conditions
- Chronic Pain, Alcohol Use, Unspecified
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.
Detailed description
This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants all undergo assessment and intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Painparticipants all receive the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the Brief Pain Inventory (BPI) non-cancer related pain.
Key exclusion criteria (6 listed)
- psychoactive medication for pain or alcohol use for few than 2 months
- history of bipolar disorder, schizophrenia, other psychotic disorder
- current suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- current behavioral treatment for pain or alcohol use
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 |
|---|---|---|
| Motivation and Cognitive Behavioral Management for Alcohol and PainBehavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference | Behavioural | Intervention |
Primary outcome
Brief Pain Inventory Pain Severity
Time frame: past 7 days
BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10
Brief Pain Inventory Pain Interference
Time frame: past 7 days
BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10
Alcohol Time Line Follow Back...Heavy Drinking Episodes
Time frame: past 30 days
number of heavy drinking episodes in the past 30 days
Alcohol Time Line Follow Back...Average Drinks Per Week
Time frame: past 30 days
average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)
Client Satisfaction Questionnaire-8 [Modified]
Time frame: past 30 days
Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32.
Perceptions of Treatment Questionnaire
Time frame: past 30 days
Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.
2 secondary outcomes
Goal Systems Assessment Battery-Pain
Time frame: past 30 days
Goal Systems Assessment Battery-Alcohol
Time frame: past 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39998790Palfai TP, Kratzer MPL, Taylor JL, Otis JD, Winter MR. Addressing Pain and Heavy Drinking among Patients in HIV-Care: A Pilot Study of an Integrated Telehealth Intervention. AIDS Behav. 2025 Jun;29(6):1930-1943. doi: 10.1007/s10461-025-04660-8. Epub 2025 Feb 25.
- Individual participant dataSharing planned: No
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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.
Tibor P Palfai, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation and Cognitive Behavioral Management for Alcohol and Pain in people with Chronic Pain and Alcohol Use, Unspecified, run by Boston University Charles River Campus 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 1 inclusion and 6 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 13 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brief Pain Inventory Pain Severity (time frame: past 7 days). The study lists 6 primary outcomes in all. 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 NCT03982433, 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 13 Dec 2019.