Alcohol Drinking and Chronic Pain InterventionNCT04441593
Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial
A study testing Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) and Treatment as Usual in people with Alcohol Drinking and Chronic Pain Intervention and Control Condition, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking and Chronic Pain Intervention, Control Condition
- What is being tested?
- Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Dec 2020to 2 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a 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 BPI, and non-cancer related pain
Who cannot join
- psychoactive medication for pain or alcohol use for fewer than 2 months
- history of bipolar disorder or schizophrenia
- current expressed suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- current behavioral treatment for pain or alcohol use
- any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215
General Clinical Research Unit, Boston University
Boston, Massachusetts, 02215
About this study
Official title: Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV
This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.
Read the detailed description
This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences
- Being tested
- Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP), Treatment as Usual
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)Behavioural
Also called Intervention
Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
Treatment as UsualBehavioural
Also called Control
Psychoeducation and Information about Treatment Resources
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Videoconferencing Intervention for Heavy Drinking and Chronic Pain Receives: Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) |
| Control | Active comparator | Treatment as Usual Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)
Measured: Past 30 days
Alcohol Time Line Follow-Back (30) - Average Drinks per Week
Average number of standard alcohol-containing drinks in the past 30 days
Measured: Past 30 days
Brief Pain Inventory - Pain Severity
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10
Measured: Past 7 days
Brief Pain Inventory - Pain Interference
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale
Measured: Past 7-Days
Secondary outcomes (3)
Short Inventory of Alcohol Problems-Revised
17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51
Measured: 3 months
Goal Systems Assessment Battery-Alcohol
Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes
Measured: Past 30 days
Goal Systems Assessment Battery-Pain
Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate 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 posted22 Jun 2020
- Study start23 Dec 2020
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Drinking and Chronic Pain InterventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare Intervention to Control Condition in a Between Subjects Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441593
- Sponsor's protocol ID
- 4546 [Study 3]
- Other IDs
- UH3AA026192
- Status last verified
- Mar 2024
- First submitted
- 18 Jun 2020
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV
- ClinicalTrials.gov ID
- NCT04441593
- Acronym / sponsor ID
- 4546 [Study 3]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 22 Jun 2020 (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.
This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.
Detailed description
This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Compare Intervention to Control Condition in a Between Subjects Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)Videoconferencing Intervention for Heavy Drinking and Chronic Pain |
| Control | Active comparator | Behavioral: Treatment as UsualTreatment as Usual |
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 defined as more than 7/14 drinks per week for women/men or by a 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 BPI, and non-cancer related pain
Key exclusion criteria (6 listed)
- psychoactive medication for pain or alcohol use for fewer than 2 months
- history of bipolar disorder or schizophrenia
- current expressed 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 |
|---|---|---|
| Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)Also: InterventionVideoconferencing intervention to reduce alcohol use and chronic pain interference and severity | Behavioural | Intervention |
| Treatment as UsualAlso: ControlPsychoeducation and Information about Treatment Resources | Behavioural | Control |
Primary outcome
Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
Time frame: Past 30 days
Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)
Alcohol Time Line Follow-Back (30) - Average Drinks per Week
Time frame: Past 30 days
Average number of standard alcohol-containing drinks in the past 30 days
Brief Pain Inventory - Pain Severity
Time frame: Past 7 days
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10
Brief Pain Inventory - Pain Interference
Time frame: Past 7-Days
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale
3 secondary outcomes
Short Inventory of Alcohol Problems-Revised
Time frame: 3 months
Goal Systems Assessment Battery-Alcohol
Time frame: Past 30 days
Goal Systems Assessment Battery-Pain
Time frame: Past 30 days
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 13 Mar 2024.
- Individual participant dataSharing planned: Yes. For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
Related trials for Alcohol Drinking and Chronic Pain Intervention
Active, not recruiting
Telehealth for Pain and Unhealthy Drinking Among PLWH
HIV, Chronic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) and Treatment as Usual in people with Alcohol Drinking and Chronic Pain Intervention and Control Condition, run by Boston University Charles River Campus at 2 sites 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes (time frame: Past 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024.