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Pain and Smoking Study - Interactive Voice Response

ConditionsSmokingPainSmoking Cessation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

being an enrolled Veteran at VACHS;

current tobacco use;

willingness to make a quit attempt;

significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days.

Disqualifiers

active diagnosis of dementia or psychosis in medical record;

severely impaired hearing or speech;

lack of telephone access;

enrollment in concurrent research study that might affect main outcomes of this study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PASS-IVR

    Behavioral

    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 to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.

  • Treatment as Usual

    Other intervention

    Referral to the local smoking cessation VA clinic.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: PASS-IVRExperimental treatment 1 intervention
Group B: Treatment as UsualOther 1 intervention

Trial outcomes

Primary outcomes

1

Cigarette Smoking Abstinence Rates

In keeping with the SNRT recommendations for measuring abstinence, we will use prolonged abstinence as our main outcome and allow for a grace period around quit date. During the 6- and 12-month follow-ups, patients will be asked about prolonged abstinence, "Since \[end of the grace period\] have you ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After \[end of the grace period\] have you smoked any in each of 2 consecutive weeks".

Time frame
6-month and 12-month follow-up

Secondary outcomes

1

Point prevalent abstinence

Patients will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will be asked whether they have smoked a cigarette, even a puff, in the past 30 days.

Time frame
6-month and 12-month follow-up
2

Pain intensity and pain-related functional interference

Pain intensity and interference will be assessed using the 11-item BPI. The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. We have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency (.96).

Time frame
baseline, 6-months follow-up, and 12-months follow-up

Other outcomes

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: