Virtual Counseling for Tobacco Addiction

Overseen By Heidi Hutton, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Tobacco cessation treatments

Disqualifiers: Cognitive impairment, Psychiatric impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using medication to help quit smoking.

What data supports the effectiveness of the treatment C-Raven for tobacco addiction?

Research shows that virtual interventions, like avatar-led programs, can be effective for smoking cessation. For example, a study found that young adults found an avatar-led digital program grounded in Acceptance and Commitment Therapy (ACT) to be satisfactory and motivating, suggesting that similar virtual treatments could help people quit smoking. ^{1 2 3 4 5}

Is virtual counseling for tobacco addiction safe for humans?

The studies reviewed focused on the feasibility and acceptability of virtual interventions for smoking cessation, but they did not report any safety concerns. Participants generally found these digital programs satisfactory and motivating, suggesting they are safe to use. ^{2 5 6 7 8}

How is the C-Raven treatment for tobacco addiction different from other treatments?

C-Raven is unique because it uses an avatar (a digital character) to deliver a computerized intervention for quitting smoking, which is different from traditional methods like phone or video counseling. This approach offers a novel, interactive experience that may engage users in a new way compared to standard treatments. ^{2 9 10 11 12}

What is the purpose of this trial?

In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control. With a sample of participants from public housing units (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. At the 3-month time point, the investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.

Research Team

Alejandra Ellison-Barnes, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for individuals living in low-income housing units in Baltimore who are struggling with tobacco addiction or use disorder. Participants should be interested in quitting smoking and willing to engage with a virtual cessation program and potentially receive lung cancer screening.

Inclusion Criteria

Planning to remain in current housing unit for 9 months

Considering smoking cessation

I am over 50 and have smoked more than 100 cigarettes in my life.

Exclusion Criteria

Investigator discretion

Current engagement in formal smoking cessation program

Major psychiatric impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Baseline Assessment

Initial evaluation including demographics, clinical history, and tobacco use history

1 day

1 visit (in-person)

Treatment

Participants receive a virtual counselor intervention for smoking cessation and nicotine replacement therapies

12 weeks

2 visits (in-person), up to 24 remote follow-ups

Follow-up

Participants are monitored for smoking cessation outcomes and intervention acceptability

6 months

Assessments at 1, 3, and 6 months

Treatment Details

Interventions

• C-Raven

Trial Overview The study tests a computerized, avatar-led tobacco cessation counseling called C-Raven, supplemented by community health worker support. It compares this approach against waiting for treatment. The effectiveness of the intervention and its implementation will be measured over six months.

Participant Groups

Group I: C-Raven + CHW Smoking Cessation Intervention Experimental Treatment 4 Interventions

Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months.

Group II: No Intervention Active Control 1 Intervention

Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Walgreens

Collaborator

Trials

1

Recruited

30+

Maryland Cigarette Restitution Fund

Collaborator

Trials

10

Recruited

900+

Walgreens

Industry Sponsor

Trials

4

Recruited

3,100+

Findings from Research

A fully automated digital smoking cessation intervention, called Happy Ending, significantly improved long-term abstinence rates among participants (22.3%) compared to a control group using a self-help booklet (13.1%) in a study of 396 smokers over 54 weeks.

The treatment group also showed better adherence to nicotine replacement therapy and higher self-efficacy after quitting, suggesting that digital interventions can effectively support behavior change in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Brendryen, H., Kraft, P.[2022]

In a study involving 725 smokers over a 6-month period, only 33.8% engaged with a trained tobacco treatment specialist (TTS) through asynchronous messaging, indicating low participant engagement.

Despite the feasibility of using asynchronous counseling to provide evidence-based support, there was no significant association between the frequency of TTS communication and smoking cessation outcomes, suggesting that future research should focus on increasing engagement and combining this method with other cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks. Sadasivam, RS., Kamberi, A., DeLaughter, K., et al.[2020]

The pilot study demonstrated that an Internet-based virtual reality program for smoking cessation was acceptable and effective for rural teens, involving seven 1-hour chat sessions over two months with a trained counselor.

Participants showed significant improvements in quitting behaviors, including reduced smoking amounts and increased intentions to quit, along with positive trends in abstinence rates and quit attempts after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot test of an Internet virtual world chat room for rural teen smokers. Woodruff, SI., Edwards, CC., Conway, TL., et al.[2019]

The web-based smoking cessation tool 'Pare de fumar conosco' significantly increased participants' interest in using pharmacotherapy and group counseling for quitting smoking, with interest levels rising from 22.4% to 82.4% and from 21.2% to 85.9%, respectively.

After 12 weeks, 9.4% of participants reported being smoke-free for at least 7 days, indicating some level of efficacy in promoting smoking cessation among Brazilian patients with chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based decision-making tool for smoking cessation (Pare de fumar conosco) among patients with chronic conditions in Brazil : one-arm feasibility study. Cupertino, AP., Cartujano-Barrera, F., Basile Colugnati, FA., et al.[2023]

A study involving 49 university student smokers found that an avatar-led digital intervention based on Acceptance and Commitment Therapy (ACT) was well-received, with participants reporting high satisfaction and motivation to quit smoking.

Participants particularly enjoyed the unique digital features of the program, such as videos and games, suggesting that future iterations should enhance the realism and interactivity of the avatars to further improve engagement and reduce dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation avatar-led Acceptance and Commitment Therapy digital intervention: feasibility and acceptability in young adults. Karekla, M., Savvides, SN.[2021]

In a lab study involving smokers and recent quitters, high realism virtual smoking scenarios increased cravings in recent quitters but decreased cravings in current smokers, highlighting the different effects of realism based on smoking status.

The findings suggest that virtual environments could be a useful tool for Cue-Exposure Therapy (CET) in smoking cessation, but further research is needed to optimize their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(No) escape from reality? Cigarette craving in virtual smoking environments. de Bruijn, GJ., de Vries, J., Bolman, C., et al.[2022]

The study assessed the feasibility and acceptability of an Embodied Conversational Agent (ECA) designed to support smoking cessation among veterans, with 6 participants using the program over 14 days.

All participants found the ECA-Q program satisfactory, and half of them set a quit date by the end of the study, indicating that this virtual coaching approach could be a helpful tool for motivating smokers to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tablet Based Embodied Conversational Agent to Promote Smoking Cessation among Veterans: A Feasibility Study. Abdullah, AS., Gaehde, S., Bickmore, T.[2020]

The Fact or Fiction Tobacco virtual health tool, launched in 2022, effectively engages users by providing tailored content and referrals to local tobacco cessation resources, reaching 2306 users in its first seven weeks.

User testing indicated that the tool is engaging and user-friendly, with 21.2% of tobacco users intending to quit and 8.8% of those not intending to quit taking action by accessing cessation resources, demonstrating its efficacy in promoting health behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fact or Fiction? The Development and Evaluation of a Tobacco Virtual Health Tool. Jessiman-Perreault, G., Dunn, R., Erza, A., et al.[2023]

Real-time video counselling for smoking cessation was found to be significantly more effective than minimal intervention control (written materials), with 18.9% of participants achieving 7-day point prevalence abstinence compared to 8.9% in the control group, based on a study of 655 rural and remote residents.

While video counselling did not show a significant difference in effectiveness compared to telephone counselling (12.7% abstinence), it suggests that integrating video counselling into smoking cessation services could enhance support for quit attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term effectiveness of real-time video counselling on smoking cessation among residents in rural and remote areas: An interim analysis of a randomised trial. Byaruhanga, J., Paul, CL., Wiggers, J., et al.[2022]

A qualitative analysis of 742 counseling messages from 270 smokers revealed that the most common theme was 'Support and Strategies for Quitting,' indicating that smokers actively seek guidance and encouragement during their cessation journey.

The study highlights the effectiveness of asynchronous online counseling as a supportive tool for smokers, providing a platform for sharing experiences and strategies throughout the quitting process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Online Asynchronous Counseling With Tobacco Treatment Specialists in the QUIT-PRIMO and National Dental PBRN HI-QUIT Studies: Who Uses It and What Do They Say? Williams, JH., DeLaughter, K., Volkman, JE., et al.[2019]

The study involved 119 adult daily cigarette smokers and assessed the feasibility of a mobile chat-based intervention combined with nicotine replacement therapy (NRT-S) for smoking cessation, showing that this approach could increase quit attempts and smoking reduction.

At the 6-month follow-up, participants receiving mobile chat support reported higher rates of quitting (10 vs 3) and smoking reduction (20 vs 11) compared to the control group, indicating that the intervention may enhance the effectiveness of NRT in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. Zhao, SZ., Wu, YS., Chau, SL., et al.[2021]

This randomized trial will compare the effectiveness of real-time video counselling, telephone counselling, and written materials for smoking cessation among regional and remote residents in New South Wales, Australia, with a focus on achieving smoking abstinence.

The study will assess the primary outcome of 7-day point prevalence abstinence at 13 months post-baseline, potentially demonstrating that video counselling could be a viable and effective alternative to traditional methods for helping people quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol. Tzelepis, F., Wiggers, J., Paul, CL., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot test of an Internet virtual world chat room for rural teen smokers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Web-based decision-making tool for smoking cessation (Pare de fumar conosco) among patients with chronic conditions in Brazil : one-arm feasibility study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Smoking cessation avatar-led Acceptance and Commitment Therapy digital intervention: feasibility and acceptability in young adults. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

(No) escape from reality? Cigarette craving in virtual smoking environments. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Tablet Based Embodied Conversational Agent to Promote Smoking Cessation among Veterans: A Feasibility Study. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Fact or Fiction? The Development and Evaluation of a Tobacco Virtual Health Tool. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The short-term effectiveness of real-time video counselling on smoking cessation among residents in rural and remote areas: An interim analysis of a randomised trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Exploring Online Asynchronous Counseling With Tobacco Treatment Specialists in the QUIT-PRIMO and National Dental PBRN HI-QUIT Studies: Who Uses It and What Do They Say? [2019]

11. Greece pubmed.ncbi.nlm.nih.gov

Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol. [2019]