IVR Therapy for Smoking Cessation and Pain

(PASS-IVR Trial)

Overseen By Lori A Bastian, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Psychosis, Terminal illness, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

220 Participants Needed

Trial Summary

What is the purpose of this trial?

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment PASS-IVR for smoking cessation and pain?

Research shows that using Interactive Voice Response (IVR) technology can help smokers who have relapsed to try quitting again by connecting them back to support services. IVR has also been used to prevent relapse in people who recently quit smoking, suggesting it can be a helpful tool in smoking cessation efforts. ^{1 2 3 4 5}

Is IVR therapy safe for humans?

The studies on Interactive Voice Response (IVR) systems for smoking cessation and alcohol use suggest that IVR is generally safe and well-tolerated by participants, with no specific safety concerns reported. Participants found the system acceptable and feasible for use in clinical trials. ^{1 2 6 7 8}

How is the PASS-IVR treatment for smoking cessation and pain different from other treatments?

PASS-IVR is unique because it uses Interactive Voice Response (IVR) technology to provide support and guidance through automated phone calls, helping individuals manage smoking cessation and pain by reinforcing coping skills and offering emotional support on demand. This approach is different from traditional methods as it allows for continuous, personalized support without the need for in-person visits. ^{1 3 4 9 10}

Research Team

Lori Anne Bastian, MD MPH

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Eligibility Criteria

This trial is for Veteran smokers who experience chronic pain and are interested in quitting smoking. Participants should be willing to receive telephone-based support.

Inclusion Criteria

Enrolled Veteran at VACHS

Current tobacco use

I am willing to try to quit smoking.

Exclusion Criteria

Lack of telephone access

Pregnancy

I have severe hearing or speech impairments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PASS-IVR intervention, which includes smoking cessation counseling, behavioral approaches for coping with pain, and nightly IVR calls. Pharmacotherapy is offered for 12 weeks.

12 weeks

Telehealth sessions and nightly IVR calls

Follow-up

Participants are monitored for cigarette abstinence rates and pain interference at 6 and 12 months.

12 months

Follow-up assessments at 6 and 12 months

Treatment Details

Interventions

• PASS-IVR

Trial Overview The study tests a phone-delivered cognitive behavioral intervention (CBI) using Interactive Voice Response (IVR) to help Veterans quit smoking, comparing it with the usual treatment methods.

Participant Groups

Group I: Treatment as Usual Experimental Treatment 1 Intervention

Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service

Group II: PASS-IVR Experimental Treatment 1 Intervention

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study involving 1785 participants, the standard quitline treatment was highly effective, with a 30-day quit rate of 61.2% at 12 months, demonstrating that traditional methods remain successful in helping smokers quit.

Adding an interactive voice response (IVR) system for relapse risk assessments did not significantly improve quit rates compared to standard treatment, indicating that while the IVR identified at-risk individuals, it did not enhance overall effectiveness in preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. McDaniel, AM., Vickerman, KA., Stump, TE., et al.[2019]

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]

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

Reaching out, inviting back: using Interactive voice response (IVR) technology to recycle relapsed smokers back to Quitline treatment--a randomized controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Correspondence of Interactive Voice Response (IVR) reports of nicotine withdrawal, craving, and negative mood with questionnaire ratings. [2021]

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

An interactive voice response system to continue a hospital-based smoking cessation intervention after discharge. [2021]

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

Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Correspondence between Interactive Voice Response (IVR) and Timeline Followback (TLFB) reports of drinking behavior. [2018]

7. England pubmed.ncbi.nlm.nih.gov

An interactive voice response (IVR) system for adolescents with alcohol use disorders: a pilot study. [2016]

8. 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]

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

Automated telephone as an adjunct for the treatment of chronic pain: a pilot study. [2019]

10. 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]