Enhancing panic and smoking reduction treatment with d-cycloserine: Study protocol for a randomized controlled trial.
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SUBMITTER: Smits JA
PROVIDER: S-EPMC4885779 | biostudies-literature | 2016 May
REPOSITORIES: biostudies-literature
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Enhancing panic and smoking reduction treatment with d-cycloserine: Study protocol for a randomized controlled trial.
Smits Jasper A J JA Kauffman Brooke Y BY Lee-Furman Eunjung E Zvolensky Michael J MJ Otto Michael W MW Piper Megan E ME Powers Mark B MB Rosenfield David D
Contemporary clinical trials 20160323
There has been relatively little attention focused on treatment strategies for smokers with panic attacks despite their increased risk of relapse. Panic and Smoking Reduction Treatment (PSRT) integrates standard smoking cessation treatment with an exposure-based intervention targeting the mechanisms underlying panic-smoking relations. Building upon emerging evidence supporting the efficacy of d-cycloserine (DCS) for augmenting exposure-based therapy, we are conducting an initial test of the effi ...[more]
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Project description:Initial studies have provided a mixed perspective of the efficacy of d-cycloserine (DCS) for augmenting the efficacy of exposure-based cognitive behavioral therapy (CBT) for panic disorder. In this multicenter trial, we examine the magnitude of DCS augmentation effects for an ultra-brief program of CBT.We conducted a double-blind, controlled trial at three treatment sites, randomizing 180 adults with a primary diagnosis of panic disorder to five sessions of treatment, with study pill (50 mg DCS or matching placebo) administered 1 hr prior to the final three sessions. Two booster sessions were subsequently provided, and outcome was assessed at posttreatment and 1-month, 2-month, and 6-month follow-up assessments. The primary outcome was the degree of reduction in the Panic Disorder Severity Scale. Additional analyses examined the role of severity and current antidepressant or benzodiazepine use as moderators of DCS augmentation effects.DCS augmentation resulted in significant benefit only early in the trial, with no beneficial effects of DCS augmentation evident at follow-up evaluations. We did not find that baseline severity or antidepressant or benzodiazepine use moderated DCS efficacy, but benzodiazepine use was associated with lower efficacy of CBT regardless of augmentation condition.Consistent with other recent multicenter trials, the benefit of DCS was less than indicated by pilot study and reflected an acceleration of treatment response evident at treatment endpoint, but no advantage in response over follow-up evaluation. Our results did not support severity or concomitant medication moderators observed in previous trials of DCS augmentation.
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Project description:BackgroundPanic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3% of the population in Sweden. Untreated, panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity, morbidity and mortality, employment difficulties, and healthcare utilization. Cognitive behavioral approaches are the recommended first-line treatment for panic disorder; however, many patients in routine care receive another evidence-based psychotherapy, including psychodynamic therapy. Allowing patients to choose among evidence-based approaches to panic disorder may improve outcomes and reduce overall health costs. Trials comparing the 'gold standard' treatment for panic disorder to other evidence-based psychotherapies are needed, and also trials that can separate patient preferences for treatment from randomization effects on outcome, disability and healthcare utilization in the longer term.Methods/designA phase 2/3 doubly-randomized controlled trial carried out in routine care with 216 adults (aged 18 to 70 years) with a primary diagnosis of DSM-IV Panic Disorder (with or without Agoraphobia). Within each clinic, patients are randomized to self-selection, random assignment of treatment, or wait-list. Patients choose or are randomly assigned to either Panic Control Treatment or Panic-Focused Psychodynamic Psychotherapy. Primary outcomes are changes in panic symptom severity, occupational status, and sickness-related absences from work at post-treatment and 6, 12 and 24 months post-treatment. Secondary outcomes include changes in agoraphobic avoidance, psychiatric comorbidity, disability, and healthcare utilization. The study also employs elements of an effectiveness trial as therapist and service-related effects on outcome will be estimated. Putative change mechanisms for the two treatments are also assessed.DiscussionCognitive behavioral and psychodynamic therapies are both evidence-based approaches that are routinely offered to panic disordered patients in Sweden. However, little is known about the relative effectiveness of these two approaches for panic/agoraphobia, work-related disability and healthcare utilization over the longer term. The current trial (POSE) also addresses the important but understudied issue of whether patient preference for a particular psychotherapeutic approach moderates outcome.Trial registrationClinicalTrials.gov NCT01606592 (registered 19 March 2012).
| S-EPMC4393576 | biostudies-literature
Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
| S-EPMC4223826 | biostudies-other
Project description:Recent studies underscore the importance of studying d-cycloserine (DCS) augmentation under conditions of adequate cue exposure treatment (CET) and protection from reconditioning experiences. In this randomized trial, we evaluated the efficacy of DCS for augmenting CET for smoking cessation under these conditions. Sixty-two smokers attained at least 18 hours abstinence following 4 weeks of smoking cessation treatment and were randomly assigned to receive a single dose of DCS (n=30) or placebo (n=32) prior to each of two sessions of CET. Mechanistic outcomes were self-reported cravings and physiologic reactivity to smoking cues. The primary clinical outcome was 6-week, biochemically-verified, continuous tobacco abstinence. DCS, relative to placebo, augmentation of CET resulted in lower self-reported craving to smoking pictorial and in vivo cues (d = 0.8 to 1.21) in a relevant subsample of participants who were reactive to cues and free from smoking-related reconditioning experiences. Select craving outcomes were correlated with smoking abstinence, and DCS augmentation was associated with a trend toward a higher continuous abstinence rate (33% vs. 13% for placebo augmentation). DCS augmentation of CET can significantly reduce cue-induced craving, supporting the therapeutic potential of DCS augmentation when applied under appropriate conditions for adequate extinction learning.
| S-EPMC6543820 | biostudies-literature
Project description:BackgroundDepression is one of the most debilitating and costly mental disorders. There is increasing evidence for the efficacy of online self-help in alleviating depression. Knowledge regarding the options of combining online self-help with inpatient psychotherapy is still limited. Therefore, we plan to evaluate an evidence-based self-help program (deprexis®; Gaia AG, Hamburg, Germany) to improve the efficacy of inpatient psychotherapy and to maintain treatment effects in the aftercare period.Methods/designDepressed patients (n = 240) with private internet access aged between 18 and 65 are recruited during psychosomatic inpatient treatment. Participants are randomized to an intervention or control group at the beginning of inpatient treatment. The intervention group (n = 120) is offered an online self-help program with 12 weekly tasks, beginning during the inpatient treatment. The control group (n = 120) obtains access to an online platform with weekly updated information on depression for the same duration. Assessments are conducted at the beginning (T0) and the end of inpatient treatment (T1), at the end of intervention (T2) and 6 months after randomization (T3). The primary outcome is the depression score measured by the Beck Depression Inventory-II at T2. Secondary outcome measures include anxiety, self-esteem, quality of life, dysfunctional cognitions and work ability.DiscussionWe expect the intervention group to benefit from additional online self-help during inpatient psychotherapy and to maintain the benefits during follow-up. This could be an important approach to develop future concepts of inpatient psychotherapy.Trial registrationClinicalTrials.gov Identifier: NCT02196896 (registered on 16 July 2014).
| S-EPMC4376072 | biostudies-literature
Project description:BackgroundCognitive behavioral therapy is the first-line treatment for patients with panic disorder (PD) and agoraphobia (AG). Yet, many patients remain untreated due to limited treatment resources. Digital self-guided short-term treatment applications may help to overcome this issue. While some therapeutic applications are already supported by health insurance companies, data on their efficacy is limited. The current study investigates the effect of self-guided digital treatment comprising psychoeducation and virtual reality exposure therapy (VRET).MethodsThirty patients diagnosed with PD, AG, or panic disorder with agoraphobia (PDA) will be randomly assigned to either the experimental group (EG) or the control group (CG). Participants of both groups will undergo baseline diagnostics in the first two sessions. The subsequent treatment for the EG consists of a self-guided 6-week phase of application-based psychoeducation, one therapy session preparing for the VRET, and 4 weeks of application-based self-guided VRET. To control for the potential effects of the therapy session with the therapist, the CG will receive relaxation and stress-reduction training instead. All patients will then undergo a closing session which terminates with the post-assessment (~ 10 weeks after baseline assessment) and a follow-up assessment 6 weeks following the closing session. Symptom severity (primary outcome) will be assessed at baseline, interim, post-treatment, and follow-up. Additionally, remission status (secondary outcome) will be obtained at follow-up. Both measures will be compared between the groups.DiscussionThe current study aims at providing insights into the efficacy of short-term treatment applications including psychoeducation and self-guided VRET. If successful, this approach might be a feasible and promising way to ease the burden of PD, AG, and PDA on the public health system and contribute to a faster access to treatment.Trial registrationISRCTN ISRCTN10661970 . Prospectively registered on 17 January 2022.
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Project description:Approximately one in four American women report bothersome urinary symptoms (e.g., urgency, frequency), which greatly impact quality of life, including mental health. Bidirectional relationships have been found between urinary symptoms and anxiety, such that urinary symptoms worsen emotional distress (i.e., anxiety and depression), and in turn anxiety can exacerbate these symptoms. Current methods to treat urinary symptoms, such as physical therapy and medications, do not address their emotional impact. As such, our multidisciplinary team is conducting a randomized control trial (RCT) of cognitive-behavior therapy (CBT) using the Unified Protocol (UP) versus supportive therapy in the context of integrated behavioral treatment in the urogynecology context. Women with bothersome urinary symptoms and anxiety are recruited from the Northwestern Medicine Integrated Pelvic Health Program (IPHP) -a transdisciplinary clinic including urogynecologists, urologists, colorectal surgeons, nurses, and physical therapists- and Northwestern Medicine Urology. Participants are randomized to one of two interventions: UP or supportive therapy. All participants attend therapy once per week for 12 weeks. Assessments of urinary symptoms, anxiety, and other indicators of psychological and physical functioning are completed at baseline, mid-treatment, post-treatment, and at 3- and 6-month follow-ups using patient-reported outcomes. The study has been preregistered on clinicaltrails.gov (ID: NCT03623880) and is currently ongoing.
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Project description:BackgroundDespite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use.Methods/designParticipants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52.DiscussionThis study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness.Trial registrationClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.
| S-EPMC4552980 | biostudies-literature
Project description:BackgroundSmoking prevalence rates among people with HIV are nearly 3 times higher than those in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV have been reported in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mobile health apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV.ObjectiveThis study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation treatment.MethodsParticipants (N=500) will be randomized to receive either standard treatment (ST; 250/500, 50%) or automated treatment (AT; 250/500, 50%). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect, was developed by our team and has been implemented in numerous health systems. ST will be compared with AT, a fully automated behavioral treatment approach. AT participants will receive nicotine replacement therapy and an interactive smartphone-based intervention that comprises individually tailored audiovisual and text content. The major goal is to determine whether AT performs better in terms of facilitating long-term smoking abstinence than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT in facilitating smoking cessation among people with HIV. As a secondary aim, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared with ST.ResultsThe intervention content has been developed and finalized. Recruitment and enrollment will begin in the fall of 2021.ConclusionsThere is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions.Trial registrationClinicalTrials.gov NCT05014282; https://clinicaltrials.gov/ct2/show/NCT05014282.International registered report identifier (irrid)PRR1-10.2196/33183.
| S-EPMC8663670 | biostudies-literature
Project description:Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials.We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81%) expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ? 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits.At the week 24 visit, the proportion of participants who achieved the protocol definition of a ? 50% smoking reduction was similar in the two treatment groups. However, the proportion that reported more extreme reductions (? 75%) was statistically significantly higher in the snus group than in the placebo group (p < 0.01). The results for biologically verified complete cessation suggested that participants in the snus group were more likely to quit smoking completely than the controls; the odds ratio (snus versus placebo) for the protocol estimates of cessation varied between 1.9 to 3.4, but these ratios were of borderline significance with p-values ranging from 0.04-0.10. Snus was well tolerated and only 2/158 (1.3%) participants in the snus group discontinued treatment due to an adverse event (in both cases unrelated to snus).Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco.www.clinicaltrials.gov, identifier: NCT00601042.
| S-EPMC3186733 | biostudies-literature