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Efficacy of smoking cessation therapy alone or integrated with prolonged exposure therapy for smokers with PTSD: Study protocol for a randomized controlled trial.

ABSTRACT: Posttraumatic stress disorder (PTSD) is related to an increased risk of smoking cessation failure. In fact, the quit rate in smokers with PTSD (23.2%) is one of the lowest of all mental disorders. Features of PTSD that contribute to smokers' progression to nicotine dependence and cessation relapse include negative affect, fear, increased arousal, irritability, anger, distress intolerance, and anxiety sensitivity. Anxiety sensitivity is higher in people with PTSD than in any other anxiety disorder except for panic disorder. High anxiety sensitivity is uniquely associated with greater odds of lapse and relapse during quit attempts. Distress intolerance, a perceived or behavioral tendency to not tolerate distress, is related to both the maintenance of PTSD and problems in quitting smoking. Prolonged exposure (PE) and interoceptive exposure (IE) reduce PTSD symptoms, distress intolerance, and anxiety sensitivity. Thus, they emerge as promising candidates to augment standard smoking cessation interventions for individuals with PTSD. The present study tests a 12-session specialized treatment for smokers with PTSD. This Integrated PTSD and Smoking Treatment (IPST) combines cognitive-behavioral therapy and nicotine replacement treatment for smoking cessation (standard care; SC) with PE to target PTSD symptoms and IE to reduce anxiety sensitivity and distress intolerance. Adult smokers (N=80) with PTSD will be randomly assigned to either: (1) IPST or (2) SC. Primary outcomes are assessed at weeks 0, 6, 8, 10, 14, 16, 22, and 30.

SUBMITTER: Powers MB

PROVIDER: S-EPMC5695545 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Efficacy of smoking cessation therapy alone or integrated with prolonged exposure therapy for smokers with PTSD: Study protocol for a randomized controlled trial.

Powers Mark B MB Kauffman Brooke Y BY Kleinsasser Anne L AL Lee-Furman Eunjung E Smits Jasper A J JA Zvolensky Michael J MJ Rosenfield David D

Contemporary clinical trials 20160825

Posttraumatic stress disorder (PTSD) is related to an increased risk of smoking cessation failure. In fact, the quit rate in smokers with PTSD (23.2%) is one of the lowest of all mental disorders. Features of PTSD that contribute to smokers' progression to nicotine dependence and cessation relapse include negative affect, fear, increased arousal, irritability, anger, distress intolerance, and anxiety sensitivity. Anxiety sensitivity is higher in people with PTSD than in any other anxiety disorde ...[more]

PMID: 27568069

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Project description:IntroductionNegative affect has been identified as a factor influencing continued smoking during pregnancy. In this study, a multi-component emotion regulation intervention was developed to address negative emotional smoking triggers and pilot-tested among low-income pregnant smokers. Treatment feasibility and acceptability, cotinine-verified rates of smoking cessation, and self-report of mean cigarettes smoked were assessed.MethodsPregnant smokers who self-reported smoking in response to negative affect (N = 70) were randomly assigned to receive one of two 8-session interventions: (1) emotion regulation treatment combined with standard cognitive-behavioral smoking cessation (ERT + CBT) or (2) a health and lifestyle plus standard smoking cessation active control (HLS + CBT). Outcomes for the 4-month period following the quit date are reported.ResultsTreatment attendance and subjective ratings provide evidence for the feasibility and acceptability of the ERT + CBT intervention. Compared with the HLS + CBT control condition, the ERT + CBT condition demonstrated higher abstinence rates at 2 months (ERT + CBT = 23% vs. HLS + CBT = 0%, OR = 13.51; 95% CI = 0.70-261.59) and 4 months (ERT = 18% vs. HLS = 5%; OR = 2.98; 95% CI = 0.39-22.72) post-quit. Mean number of cigarettes per day was significantly lower in ERT + CBT at 2 months (ERT + CBT = 2.73 (3.35) vs. HLS + CBT = 5.84 (6.24); p = .05) but not at 4 months (ERT + CBT = 2.15 (3.17) vs. HLS + CBT = 5.18 (2.88); p = .06) post-quit.ConclusionsThe development and initial test of the ERT + CBT intervention supports its feasibility and acceptability in this difficult-to-treat population. Further development and testing in a Stage II randomized clinical trial are warranted.ImplicationsNegative affect has been identified as a motivator for continued smoking during pregnancy. To date, smoking cessation interventions for pregnant smokers have not specifically addressed the role of negative affect as a smoking trigger. This treatment development pilot study provides support for the feasibility and acceptability of a multi-component ERT + CBT for low-income pregnant smokers who self-report smoking in response to negative affect. Study findings support further testing in a fully-powered Stage II efficacy trial powered to assess mediators and moderators of treatment effects.

Project description:Background: Suboptimal response and high dropout rates leave room for improvement of trauma-focused treatment (TFT) effectiveness in ameliorating posttraumatic stress disorder (PTSD) symptoms. Objective: To explore the effectiveness and safety of intensive prolonged exposure (iPE) targeting chronic PTSD patients with a likely diagnosis of ICD-11 Complex PTSD following multiple interpersonal trauma and a history of multiple treatment attempts. Method: Participants (N = 73) received iPE in 12 × 90-minute sessions over four days (intensive phase) followed by four weekly 90-minute booster prolonged exposure (PE) sessions (booster phase). The primary outcomes, clinician-rated severity of PTSD symptoms, and diagnostic status (Clinician-Administered PTSD Scale; CAPS-IV) were assessed at baseline, post-treatment, and at three and six months. Treatment response trajectories were identified and predictors of these trajectories explored. Results: Mixed model repeated measures analysis of CAPS-IV scores showed a baseline-to-posttreatment decrease in PTSD symptom severity (p < .001) that persisted during the three- and six-month follow-ups with large effect sizes (Cohen's d > 1.2); 71% of the participants responded. None of the participants dropped out during the intensive phase and only 5% during the booster phase. Adverse events were extremely low and only a minority showed symptom exacerbation. Cluster analysis demonstrated four treatment response trajectories: Fast responders (13%), Slow responders (26%), Partial responders (32%), and Non-responders (29%). Living condition and between-session fear habituation were found to predict outcome. Participants living alone were more likely to belong to the Partial responders than to the Non-responders cluster, and participants showing more between-session fear habituation were more likely to belong to the Fast responders than to the Non-responders cluster. Conclusions: The results of this open study suggest that iPE can be effective in PTSD patients with multiple interpersonal trauma and after multiple previous treatment attempts. In addition, in this chronic PTSD population iPE was safe.

Project description:BackgroundBlack smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation.ObjectiveThis study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation.MethodsIn phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones.ResultsThis project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022.ConclusionsIf successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation.Trial registrationClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236.International registered report identifier (irrid)DERR1-10.2196/38905.

Dataset Information

Efficacy of smoking cessation therapy alone or integrated with prolonged exposure therapy for smokers with PTSD: Study protocol for a randomized controlled trial.

Publications

Efficacy of smoking cessation therapy alone or integrated with prolonged exposure therapy for smokers with PTSD: Study protocol for a randomized controlled trial.

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