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. Author manuscript; available in PMC: 2022 May 15.
Published in final edited form as: J Addict Med. 2019 Jul-Aug;13(4):322–330. doi: 10.1097/ADM.0000000000000502

Pilot Trial of a Combined Cognitive Processing Therapy and Smoking Cessation Treatment

Eric A Dedert 1,2,3, Patricia A Resick 2, Paul A Dennis 1,2,3, Sarah M Wilson 1,2,3,4, Scott D Moore 1,2,3, Jean C Beckham 1,2,3
PMCID: PMC9107776  NIHMSID: NIHMS1793292  PMID: 30664539

Abstract

Objective/Background:

Posttraumatic stress disorder (PTSD) and smoking are often comorbid. Combining PTSD and smoking cessation treatments could increase access to each treatment and could provide improved rates of smoking cessation through reductions in PTSD and depressive symptoms.

Participants:

Participants were veterans with current PTSD who smoked cigarettes and were willing to initiate treatment for both problems.

Methods:

We conducted a randomized pilot trial to explore feasibility and estimate effect sizes of a treatment combining trauma-focused Cognitive Processing Therapy (CPT) with smoking cessation counseling and pharmacotherapy, relative to the same smoking cessation treatment without CPT.

Results:

Rates of biochemically verified 7-day point prevalence smoking abstinence at the end of treatment or at 6-month follow-up were similar across treatments. Relative to the comparison, the combined CPT and smoking cessation treatment resulted in effect sizes suggestive of moderate to large reductions in PTSD symptoms, Cohen’s d = 0.718, 95% Confidence Interval (CI) = 0.078, 1.358) that decreased by the 6-month follow-up, Cohen’s d = 0.306, 95% CI = −0.334, 0.946); and suggestive of large reductions in depressive symptoms that were maintained to the 6-month follow-up, Cohen’s d = 1.007, 95% CI = 0.367, 1.647.

Conclusions:

Results did not suggest that CPT or psychiatric symptom reductions had a long-term effect on smoking cessation. However, results suggest that combining CPT and smoking cessation treatment results in both expected reductions of psychiatric symptoms along with smoking abstinence rates similar to previous smoking cessation trials in veterans with PTSD.

Keywords: tobacco use, posttraumatic stress disorder, smoking cessation, traumatic stress, comorbidity

Introduction

Smoking cigarettes is the leading cause of preventable death in the United States (U.S.) (Centers for Disease Control and Prevention, 2005) and is especially prevalent in U.S. military veterans with posttraumatic stress disorder (PTSD) (Beckham et al., 1997). Despite good efficacy of specialty smoking cessation clinic care in the Veterans Health Administration (VHA) (Fiore et al., 2000). a review of electronic health record data from VHA found that only 6% of veterans with PTSD access available specialty smoking cessation clinic counseling (Kelly, 2017). There is a critical need to develop effective interventions for veterans with PTSD who smoke cigarettes.

Existing evidence suggests that smoking in veterans with PTSD is maintained by their psychiatric symptoms. People with PTSD are more likely to smoke in response to negative affect and PTSD symptoms (Beckham et al., 2005), report significantly greater relief of craving and psychological distress symptoms after smoking (Beckham et al., 2007), and have lapses to smoking during quit attempts that are triggered by PTSD symptoms (Beckham, Calhoun, Dennis, Wilson, & Dedert, 2013; Dedert, Hicks, Dennis, Calhoun, & Beckham, 2016). Interventions that provide effective PTSD treatment could be an effective way to engage people with PTSD in smoking cessation interventions and provide the coping skills needed to prevent relapse.

The most effective smoking cessation approach to date for PTSD smokers, Integrated Care for Smoking Cessation (ICSC), trained PTSD therapists in smoking cessation counseling so that smoking cessation treatment is delivered by therapists who are knowledgeable in the barriers to smoking cessation presented by PTSD (McFall et al., 2010). A large, multisite trial found that smoking cessation counseling delivered by PTSD therapists produced 7-day point prevalence smoking abstinence in 17% of participants, relative to 7% smoking abstinence in the group referred for care at specialty smoking cessation clinics. However, there was little change in psychiatric symptoms, with no difference between treatment conditions in PTSD or depressive symptoms (McFall et al., 2010). Unfortunately, subsequent trials of combined PTSD and smoking cessation treatment have found no significant advantage in smoking abstinence, relative to comparison groups (Battaglia et al., 2016; Foa et al., 2017; Gonzalez et al., 2017). In addition, combined PTSD and smoking cessation treatments have found small between-group differences (Battaglia et al., 2016) or no significant differences in psychiatric symptoms (Foa et al., 2017; Gonzalez et al., 2017). Finally, a review of comorbid PTSD and substance use disorders (SUD) found that, during the treatment period, trials comparing combined PTSD and SUD treatments to SUD treatments alone have found no relative benefit of combined treatment for either psychiatric symptoms or substance use outcomes (Roberts, Roberts, Jones, & Bisson, 2016). Treatments for comorbid PTSD and SUD have also been limited by treatment dropout. A review found that approximately half of participants with comorbid PTSD and SUD drop out of treatment (Simpson, Lehavot, & Petrakis, 2017).

PTSD and depressive symptoms can be effectively reduced by using Cognitive Processing Therapy (CPT), a treatment with demonstrated efficacy in veterans (Chard, Schumm, Owens, & Cottingham, 2010; Forbes et al., 2012; Monson et al., 2006; P. A. Resick et al., 2017). One single-group study (n = 15) combined CPT with smoking cessation counseling and found evidence of improvements in psychiatric symptoms and smoking abstinence bioverified by carbon monoxide (CO) < 8 parts per million (ppm) at 6-month follow-up (Dedert, Resick, et al., 2016). We sought to investigate the combined CPT and smoking cessation treatment further by conducting a pilot trial to evaluate study feasibility and estimate treatment effect sizes for a treatment combining CPT and smoking cessation treatment for veterans with PTSD. This pilot trial aimed to 1) evaluate the feasibility of treatment and study procedures, 2) characterize differences between treatment conditions, and 3) evaluate mechanisms of treatment outcomes to inform models of comorbid PTSD and cigarette smoking.

Methods

2.1. Participants and Procedures

Sociodemographic characteristics and baseline descriptive statistics are presented in Table 1. Participants were 50 veterans who were willing to receive treatment for both PTSD and cigarette smoking. Veterans were informed of the study by providers in VA clinics, through flyers in the community and at VA, by informational tables set up in the Durham VA Health Care System, and through letters sent to veterans with PTSD and tobacco use disorder inviting them to call for smoking cessation and PTSD treatment. Eligible participants were veterans who smoked ≥ 10 cigarettes per day, were willing to attempt smoking cessation, met current criteria for PTSD, had a stable medication regimen, were fluent in the English language, and ages 18–75. Participants were excluded for myocardial infarction in the preceding 6 months, no medical clearance to use nicotine replacement therapy, used other forms of tobacco (e.g., cigars, chewing tobacco, electronic cigarettes), were unable to complete study procedures, had dementia, schizophrenia, or current manic episode, had substance abuse/dependence in the preceding 3 months, were receiving trauma-focused psychotherapy or behavioral smoking treatment, or currently resided in court-ordered residential substance abuse setting. The CONSORT diagram of recruitment and participation is displayed in Figure 1. Participants were compensated $50 for attending the screening session, and could earn up to $495 in compensation for equipment return, provision of biological samples, and completion of study measures, including daily ecological momentary assessments of psychiatric symptoms and situational assessments of smoking occasions (Dedert et al., 2014) that will be reported in a subsequent manuscript. This study was approved by the Durham VA Health Care System Institutional Review Board.

Table 1.

Baseline Sociodemographic and Clinical Variables

Sociodemographic Variable CPTS (n=15) PS (n=25) Significance Test

Frequency (%) Frequency (%)

Race
 African American 9 (60%) 14 (56%)
 Caucasian 3 (20%) 7 (28%)
 Hispanic 2 (13%) 0 (0%)
 Multiple Races 1 (7%) 4 (16%)
Sex (% Male) 14 (93%) 19 (76%) X2 (1) = 1.95, p = .163
Marital Status X2 (1) = 0.11, p = .744
 Married/Cohabitating 7 (47%) 13 (52%)
 Single 8 (53%) 12 (48%)
Psychiatric Disorders
 Current Major Depression 5 (33%) 10 (40%) X2 (1) = 0.27, p = .603
 Lifetime Major Depression 7 (47%) 14 (56%) X2 (1) = 0.51, p = .477
 Lifetime Alcohol Use Disorder 10 (67%) 14 (56%) X2 (1) = 0.44, p = .505
 Lifetime Drug Dependence 13 (87%) 16 (64%) X2 (1) = 1.47, p = .226

Baseline Value Mean (SD) Mean (SD) Significance Test

Age (years) 43.1 (10.8) 53.3 (10.8) t(38) = 2.90, p = .006
Education (years) 13.4 (1.4) 13.3 (2.8) t(37) = 0.06, p = .956
CAPS-5 43.9 (8.1) 36.2 (10.4) t(38) = 2.44, p = .020
PCL-5 54.6 (11.5) 46.0 (16.6) t(37) = 1.81, p = .008
BDI-II 32.6 (10.4) 24.1 (13.3) t(38) = 2.10, p = .042
Cigarettes/day 13.9 (4.8) 16.0 (5.9) t(38) = 1.16, p = .006
Fagerstrom Nicotine Dependence 4.8 (1.9) 5.0 (2.2) t(38) = 0.29, p = .773
*

p < .05,

**

p < .01.

CPTS = Combined Trauma-focused Cognitive Processing Therapy and Smoking Cessation Treatment. PS = Present-focused Smoking Cessation Treatment. BDI-II = Beck Depression Inventory, Version 2. CAPS-5 = Clinician-Administered PTSD Scale for DSM-V. PCL-5 = Posttraumatic Stress Disorder Checklist for DSM-V.

Figure 1. CONSORT Flow Diagram for Trial.

Figure 1.

2.2. Measures

On the screening date, participants completed a background and sociodemographic measure, and other self-report measures and diagnostic interviews. Clinical interviewers completed training in diagnostic interview administration, including review of interviewer manuals, training videos, and co-rating with an experienced rater. Interviewers received ongoing supervision from experienced clinicians. Clinical interviewers demonstrated excellent reliability (Fleiss’ kappa = 0.91) when scoring a series of diagnostic interview training videos.

2.2.1. Clinician Administered PTSD Scale-5 (CAPS-5)

(F.W. Weathers et al., 2013) is a semi-structured interview assessing the PTSD symptoms for DSM-5 (American Psychiatric Association, 2013). The monthly version of the CAPS-5 was administered at screening, immediately following the end of treatment, and at 6-month follow-up. To ensure treatment condition masking, CAPS interviewers were not involved in other study activities. The CAPS-5 has demonstrated good inter-rater reliability (intraclass correlation coefficient = .91), as well as good convergent and discriminant validity (F. W. Weathers et al., 2017).

2.2.2. Structured Clinical Interview for DSM-IV-TR

(SCID) (First & Pincus, 2002) is a well-established diagnostic interview that was administered at screening to evaluate inclusion/exclusion criteria and characterize the sample.

2.2.3. PTSD Checklist-5

(PCL-5 (Blevins, Weathers, Davis, & Witte, 2015)) was administered at each study session to assess self-reported PTSD symptoms over the past week. It is a 20-item measure that has one item assessing each of the PTSD diagnostic criteria for DSM-5 (American Psychiatric Association, 2013) on a scale of 0 to 4, with higher scores indicating greater severity.

2.2.4. Beck Depression Inventory-II

(BDI-II (Beck, Steer, & Brown, 1996)) is well-established as a reliable and valid measure of depressive symptoms. It was administered at each study session to assess depressive symptoms during the past two weeks. The scale consists of 21 self-report items that are rated from 0 to 3, with higher scores indicating greater severity.

2.2.5. Fagerstrom Test of Nicotine Dependence (Pomerleau, Carton, Lutzke, Flessland, & Pomerleau, 1994)

is a 6-item self-report measure with a range of 0–10 that assesses the severity of dependence on and withdrawal from nicotine, with a score > 6 indicating high dependence.

2.2.6. Smoking Status

At the screening session and each post-quit session, participants reported on whether they had smoked in the past seven days, number of cigarettes per smoking day. Participants also breathed into a piCO+™ carbon monoxide (CO) monitor (coVita, Santa Barbara, CA) to bioverify smoking status. Recent validation research has determined that using a CO < 8 cutoff to bioverify smoking abstinence misclassifies 14% of smokers as being abstinent (Cropsey et al., 2014). Thus, we used a cutoff of CO < 4 to bioverify smoking abstinence in the pilot trial.

2.3. Procedures for randomization and intervention design

All participants were randomized following baseline data collection. The complete randomization sequence was generated a priori and performed centrally by study staff that had no contact with participants or daily conduct of the study. Randomization was stratified by the presence/absence of current major depressive disorder and Fagerstrom nicotine dependence score ≥ 6.

2.4. Present-focused Smoking Treatment Arm

All participants in the present-focused smoking cessation (PS) group received 12 sessions of standard cognitive behavioral smoking cessation treatment based on the treatment manual for ICSC (McFall et al., 2010). This treatment was present-focused (i.e., no trauma-focused exposure or cognitive processing of the traumatic event). Sessions were designed to last 25 minutes. Participants in the present-focused smoking (PS) treatment were treated by the same therapists that provided treatment in the combined treatment condition to balance therapist effects. Consistent with the ICSC treatment approach, participants in both arms were contacted by phone monthly after the end of treatment for a brief (5–10 minutes) relapse prevention call to reinforce smoking abstinence and to encourage participants who lapsed or relapsed to smoking to make additional smoking cessation attempts. All participants were encouraged to sign up for a free, publicly available supportive text messaging service called SmokeFreeVET that provided automated texts from a group of messages developed specifically for veterans. Participants received 1–5 texts per day beginning two weeks before the quit date and ending four weeks after the quit date. The smoking cessation treatment in this arm was identical to the smoking cessation component of the CPTS group, except that the PS arm did not utilize formal cognitive restructuring to address smoking triggers.

2.5. Combined Cognitive Processing Therapy and Smoking Cessation

In the combined CPT and smoking cessation (CPTS) arm, smoking was conceptualized and integrated into treatment as an avoidance behavior that interferes with processing PTSD symptoms. Each of 12 sessions began with a standard session of standard CPT, (P. Resick, Monson, & Chard, 2016) followed by 25 minutes of smoking cessation content from the ICSC treatment. CPT is a manualized psychotherapy for PTSD that includes cognitive processing of extreme, inaccurate, or overgeneralized cognitions related to the traumatic event and domains affected by the trauma. Participants in the combined condition were encouraged to use cognitive restructuring skills acquired in CPT to identify and address cognitions that increased risk of smoking lapse. These cognitions were entered by participants on the CPT stuck point log as cognitions that kept participants from moving past their smoking habit. Participants were discouraged from smoking while completing CPT worksheets addressing PTSD-related beliefs.

2.6. Therapist Training and Fidelity

Three PhD-level clinical psychologists and two Master’s-level mental health providers provided therapy in both conditions. Therapists had received formal two-day training in CPT and a half-day training in ICSC. Therapists met weekly to discuss case conceptualization and approaches to addressing problems that arose during therapy. Following procedures used in previous CPT trials (P. A. Resick et al., 2008; Suris, Link-Malcolm, Chard, Ahn, & North, 2013), therapists in the CPT arm completed a total of ten practice cases to establish fidelity rated from video-recorded CPT sessions, with all subsequent cases included in primary data analyses. This resulted in 15 participants who received the combined CPT and smoking treatment and were included in primary analyses. CPT treatment fidelity across study therapists for the 15 CPT cases were good, with 98% adherence, with 0% of sessions including proscribed treatment components. Mean ratings on the 5-point fidelity rating scales were between “Very Good” and “Excellent” for Competence (M = 4.4, SD = 0.9) and for use of Essential treatment components (M = 4.5, SD = 0.7).

2.7. Pharmacotherapy

All participants were encouraged to use standard smoking cessation pharmacotherapy prescribed by the study physician, including 6 weeks of nicotine patch, and one nicotine rescue method (gum or lozenge) to be used through the follow-up period to address cravings. Participants with no contraindications, or who received permission from their medical provider, were also encouraged to use bupropion to reduce withdrawal symptoms and cigarette cravings. Participants who lapsed or relapsed were encouraged to set a new quit date and continue their cessation attempt.

2.8. Analysis Plan

To remain consistent with guidelines for evaluating pilot trials, data analyses were primarily descriptive and focused on estimating effect sizes and confidence intervals for treatment outcomes and mechanisms (Thabane et al., 2010), rather than confirmatory hypothesis testing. Analyses were conducted using SAS 9.4 software (SAS Institute Inc., Cary, NC, USA). Based on procedures for analyzing trial data (Fitzmaurice, Laird, & Ware, 2004), we analyzed primary outcomes using mixed random and fixed effect regression models. Missing single session data were imputed using data from the nearest session in time (Lamp, Avallone, Maieritsch, Buchholz, & Rauch, 2018). Missing data after dropout were estimated using maximum likelihood methods from SAS proc mixed (for continuous outcomes) or proc glimmix (for dichotomous outcomes). For continuous outcomes, we modeled outcome scores measured at baseline, post-treatment, and 6-month follow-up as a function of measurement time (dummy-coded such that baseline scores represented the reference value) and the interaction between treatment and time of measurement. For abstinence, a dichotomous outcome, we modeled abstinence status at post-treatment and 6-month follow-up as a function of time of measurement and the interaction between treatment and time. Statistically significant baseline differences were covaried in adjusted models, and all models of psychiatric symptoms constrained the baseline values to be equal across treatment groups (Fitzmaurice et al., 2004). The primary outcome was smoking abstinence bioverified by CO at 6-months after the date of the initial attempt to quit smoking.

To explore the relationship of reduced post-treatment psychiatric symptoms to smoking abstinence at the 6-month follow-up, we calculated mixed models predicting an outcome vector including post-treatment and 6-month smoking status with one post-treatment symptom measure (PCL-5, CAPS-5, or BDI-II), a dummy-coded indicator for the 6-month timepoint, and their interaction. A total of three models were calculated to estimate the effect size of the interaction between post-treatment psychiatric symptoms and time.

Results

Between December, 2013 and July, 2017, 69 participants attended screening procedures for this study, and 50 (72%) were enrolled and randomized and provided study data. The 19 exclusions were for no current PTSD (n = 8, 42%), insufficient volume of smoking (n = 4, 21%), current substance use disorder (n = 3, 16%), psychotic disorder (n = 2, 11%), manic episode at the time of the screen (n = 1, 5%), and behavioral smoking cessation treatment at the time of the screen (n = 1, 5%). No potentially eligible participants declined to participate in the study due to concerns about videotaping therapy sessions. Baseline sociodemographic and psychiatric characteristics are described in Table 1.

Defining treatment completion as attending all 12 treatment sessions, 8/25 (32%) participants dropped out of the PS treatment, and 4/15 (27%) dropped out of the CPTS treatment. Rates of study retention, as measured by attendance at 6-month follow-up, were similar across groups (CPTS group: 80%, PS group: 72%). Less than half of participants used the supportive text treatment component, n = 16 (40%).

The 40 participants providing data for study analyses reported a total of 50 adverse events. Adverse events were primarily due to medical problems (e.g., chronic pain, pulmonary disease exacerbation, flu symptoms) and potential side effects of smoking cessation withdrawal symptoms and/or pharmacotherapy (e.g., nausea, coughing, headache). No serious adverse events were determined to be study-related.

3.1. Smoking Cessation and Smoking Reduction

Results are listed in Table 2. Among those attending post-treatment sessions, CO-bioverified (CO < 4ppm) 7-day point prevalence abstinence was 3/11 (27%) in the CPTS group, and 5/17 (29%) in the PS group. Assuming missing data indicated continued smoking, the CPTS group had 3/15 (20%) abstinent, and the PS group had 5/25 (20%) abstinent. As indicated in Table 2, between-group differences were not suggested by results of unadjusted models or models adjusting for baseline age and PTSD symptoms. Among those attending 6-month follow-ups, 2/12 (17%) were bioverified abstinent in the CPTS group, and 4/19 (21%) were bioverified abstinent in the PS group. Assuming missing data indicated continued smoking, 2/15 (13%) in the CPTS group and 4/25 (16%) in the PS group were bioverified abstinent at 6 months. Between-group differences were not suggested by unadjusted models or models adjusting for baseline age and PTSD symptoms. Reduction in cigarettes smoked per day was also similar across treatment conditions at post-treatment (CPTS: 83% reduction; PS: 84% reduction) and at 6-month follow-up (CPTS: 65% reduction; PS: 66% reduction).

Table 2.

Major Study Outcomes by Time Point and Group

Outcomes Baseline Post-Treatment Change Score Within-group Effect 6-Month Follow-up Change Score Within-group Effect

PCL-5

 CPTS
Condition
55.1 (11.8) 33.0 (17.7) −21.09 (16.89) d = 1.249 42.6 (18.3) −8.27 (17.07) d = 0.484
 PS
Condition
46.0 (16.6) 38.5 (21.6) −10.38 (15.31) d = 0.678 43.5 (23.3) −5.84 (19.34) d = 0.302
 Unadjusted Between-groups d = 0.724 (0.084, 1.364) d = 0.317 (−0.323, 0.957)
Mixed Model Effect (95% CI)
Adjusted Between-groups d = 0.718 (0.078, 1.358) d = 0.306 (−0.334, 0.946)
Mixed Model Effect (95% CI)

CAPS-5

 CPTS
Condition
43.9 (8.1) 34.1 (13.3) −9.82 (14.30) d = 0.687 36.6 (15.3) −6.3 (11.9) d = 0.529
 PS
Condition
36.2 (10.4) 32.4 (20.4) −3.82 (13.34) d = 0.687 35.1 (17.9) −1.17 (13.98) d = 0.084
 Unadjusted Between-group Mixed Model Effect (95% CI) d = 0.505
(−0.135, 1.145)
d = 0.336 (−0.304, 0.976)
 Adjusted Between-group Mixed Model Effect (95% CI) d = 0.507 (−0.137, 1.147) d = 0.346 (−0.294, 0.986)

BDI-II

 CPTS
Condition
32.6 (10.4) 22.5 (12.1) −11.18 (5.72) d = 1.955 21.3 (15.7) −11.07 (9.28) d = 1.193
 PS Condition 24.1 (13.3) 21.5 (15.5) −3.29 (6.39) d = 0.515 24.1 (16.5) −0.89 (9.72) d = 0.092
 Unadjusted Between-group Mixed Model Effect (95% CI) d = 0.931 (0.291, 1.571) d = 0.998 (0.358, 1.638)
 Adjusted Between-group Mixed Model Effect (95% CI) d = 0.936 (0.296, 1.576) d = 1.007 (0.367, 1.647)

Bioverified Smoking Abstinence (CO < 4) -

-
 CPTS Condition - 3/15 (20%) - 2/15 (13%) -
 PS Condition 5/25 (20%) - 4/25 (16%) -
 Unadjusted Between- group Mixed Model Effect (95% CI) OR = 0.90 (0.15, 5.29) OR = 0.75 (0.11, 5.32)
 Adjusted Between-group Mixed Model Effect (95% CI) OR = 0.99 (0.11, 8.62) OR = 0.87 (0.06, 11.90)

Cigarettes/day

 CPTS Condition 13.9 (4.8) 2.4 (4.6) −12.7 (5.9) 4.8 (4.7) −10.0 (3.8)
 PS Condition 16.0 (5.9) 2.6 (4.5) −13.9 (7.8) 5.5 (6.9) −10.7 (7.1)
 Unadjusted Between-group Mixed Model Effect (95% CI) d = 0.073
(−0.567, 0.713)
d = 0.000
(−0.640, 0.640)
 Adjusted Between-group Mixed Model Effect (95% CI) d = 0.065 (−0.575, 0.705) d = 0.000
(−0.640, 0.640)

Adjusted mixed models of PTSD and depression covaried for age. Adjusted mixed models of smoking status covaried for age and baseline CAPS-5. PCL-5 = Posttraumatic Stress Disorder Checklist for DSM-5. CAPS-5 = Clinician-Administered PTSD Scale for DSM-5. BDI-II = Beck Depression Inventory (BDI-II). 95% CI = 95% Confidence Interval. d = Cohen’s d effect size estimate.

3.2. Psychiatric Symptoms

Results are listed in Table 2. Mixed models found that, relative to the PS intervention, the CPTS intervention resulted in post-treatment effect sizes suggestive of moderate to large reductions in PTSD symptoms on the PCL-5 in the unadjusted model (see Figure 2) and in the age-adjusted model. Between-group differences in favor of the CPTS intervention were suggestive of a small effect size at the 6-month follow-up in the unadjusted model and in the age-adjusted model. Relative to the PS intervention, the CPTS intervention also resulted in post-treatment effect sizes suggestive of moderate reductions in PTSD symptoms at post-treatment and small effects at the 6-month follow-up on the CAPS-5 in the unadjusted model and in the age-adjusted model. Finally, mixed models found between-group differences suggestive of large reductions in depressive symptoms at both post-treatment and 6-month follow-up in the unadjusted model (see Figure 3) and age-adjusted model.

Figure 2. Change in PTSD Symptoms by treatment condition.

Figure 2.

CPTS = Combined Cognitive Processing Therapy and Smoking Cessation Treatment. PS = Present-focused Smoking Cessation Treatment.

Figure 3. Change in Depressive symptoms by treatment condition.

Figure 3.

CPTS = Combined Cognitive Processing Therapy and Smoking Cessation Treatment. PS = Present-focused Smoking Cessation Treatment.

3.3. Association of Bupropion with Smoking Cessation

Bupropion was prescribed for 18/40 (45%) of participants, including 9/15 (60%) in the CPTS group and 9/25 (36%) in the PS group (χ2 (1) = 2.18, p = .140). At post-treatment, smoking abstinence was observed in 4/18 (22%) participants who were prescribed bupropion, and 4/22 (18%) of participants who were not prescribed bupropion. At 6-month follow-up, smoking abstinence was observed in 4/18 (22%) of participants who were prescribed bupropion, and 2/22 (9%) of participants who were not prescribed bupropion.

3.4. Association of Psychiatric Symptoms with Smoking Abstinence

Mixed models of the interaction of post-treatment PCL-5 symptoms and time found no evidence of an effect of lower PTSD symptoms on long-term smoking abstinence, d = −.095, 95% CI (−0.853, 0.664). A separate model of the interaction between post-treatment CAPS-5 symptoms on time found a small effect of lower PTSD symptoms on long-term smoking abstinence, d = .208, 95% CI (−0.551, 0.967). Finally, a separate model of the interaction between post-treatment BDI symptoms on time found no evidence of an effect of lower depressive symptoms on long-term smoking abstinence, d = .000, 95% CI (−0.759, 0.759).

Discussion

Observations from this pilot trial provide preliminary evidence that veterans with PTSD and comorbid cigarette smoking will engage in combined CPT and smoking cessation treatment, as well as smoking cessation treatment by a PTSD provider without CPT. The rates of treatment completion were higher than those observed in previous trials of interventions for comorbid PTSD and SUD (Simpson et al., 2017).

Though the large confidence intervals resulting from the small sample size of the pilot trial precludes firm conclusions, this study provides some support for combining smoking cessation with evidence-based trauma-focused treatment. Because the standard for bioverification by CO has changed in recent years (Cropsey et al., 2014), it is difficult to make direct comparisons between current trials that use a CO cut-off of 4 and previous trials that used a cut-off of 8ppm (Foa et al., 2017; McFall et al., 2010) or 10ppm (Battaglia et al., 2016). The smoking cessation rate in the current pilot trial was within range of the 17% 6-month follow-up point prevalence abstinence observed in the ICSC trial (McFall et al., 2010), which combined smoking cessation with a variety of PTSD treatments. Though this pilot trial does not suggest beneficial effects of PTSD symptom reduction on subsequence smoking cessation, evidence from this study and larger trials (Battaglia et al., 2016; Foa et al., 2017; Gonzalez et al., 2017; McFall et al., 2010) suggests that smoking cessation rates are maintained when combining smoking cessation with PTSD treatments.

Because meta-analysis has found that the effects of trauma-focused therapy, such as CPT, on substance use might only be exerted at longer follow-ups (Roberts et al., 2016), it would be worthwhile for future studies to incorporate follow-ups later than the 6 months employed in the current trial. This study had effects consistent with an advantage for CPTS, relative to SUD treatment without trauma-focused therapy, for reducing psychiatric symptoms. This conflicts with a review finding no difference when combined treatment was compared to SUD treatment (Roberts et al., 2016). A larger study would be useful in forming a more precise estimate of the effect of combined CPT and smoking cessation treatment on psychiatric symptoms.

This trial was limited by the lack of follow-up beyond 6 months, which meta-analysis (Roberts et al., 2016) suggests is the time when effects trauma-focused therapy, such as CPT, on decreased risk of relapse might be evident (Roberts et al., 2016). Because the monthly version of the CAPS-5 was administered immediately post-treatment, it likely underestimated effects of treatment on PTSD symptoms due to overlap of the assessment period with new material presented in treatment. As a result, the PCL-5 is a more precise estimate of post-treatment effects on PTSD symptoms. Because participants were encouraged to use nicotine replacement to address cravings, we could not use complement CO bioverification with salivary cotinine bioverification. Emerging bioverification methods that can discriminate between nicotine use and tobacco smoking (McGuffey et al., 2014) will be useful for assessing long-term smoking abstinence among those using nicotine replacement.

Based on the moderate to large effect size decreases in PTSD and depressive symptoms at the end of treatment, it is likely feasible to address PTSD and depressive symptoms using combined CPT and smoking cessation treatment. Nevertheless, combined treatment could be utilized as a means of engaging veterans seeking treatment for their PTSD into smoking cessation treatment at the same visits. In addition, the reduction in PTSD and depressive symptoms resulting from CPT in previous trials and suggested by the effect size estimates in this pilot trial are a substantial advantage for patients regardless of whether they stop smoking. In sum, empirical evidence to date, including the current study, suggests that veterans with PTSD can effectively stop smoking when treated by a PTSD provider, including treatments that include CPT for PTSD.

Acknowledgements

We would like to express our gratitude to the participants who volunteered to participate in this study. We would also like to express gratitude to Maren Olsen, Ph.D., who provided mentorship on this project. The views expressed in this presentation are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the National Institutes of Health. This work was primarily supported by award number 1IK2CX000718 to Dr. Dedert from the CSR&D Service of the VA Office of Research and Development. This work was primarily supported by award number IK2HX002398 to Dr. Wilson from the HSR&D Service of the VA Office of Research and Development.

Footnotes

Trial Registry: This trial was registered with clinicaltrials.gov (NCT01901848)

Conflicts of Interest

The investigators declare no affiliations or financial involvement that conflict with material presented in this report.

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