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A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

ABSTRACT: It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent individuals; 2) to investigate whether CET as a smartphone application is as or more effective than CET group therapy, and 3) to investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual.The study will be implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Aftercare as Usual. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to the control group (3).Individuals in the CET groups are given the opportunity to practise coping strategies during exposure to alcohol stimuli before being unavoidably confronted with alcohol and associated stimuli in real life. Thus, CET may help prevent patients from relapsing after concluding treatment, and in the long term. Moreover, the CET application has the potential to improve AUD treatment and continuing care by offering psychological treatment whenever and wherever the patient finds it convenient.ClinicalTrials.gov ID: NCT02298751 Registration date: 6 November 2014.

SUBMITTER: Mellentin AI

PROVIDER: S-EPMC4839102 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

Mellentin Angelina Isabella AI Nielsen Bent B Nielsen Anette Søgaard AS Yu Fei F Stenager Elsebeth E

BMC psychiatry 20160421

<h4>Background</h4>It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphon ...[more]

PMID: 27098817

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Project description:BackgroundCue exposure therapy (CET) is a psychological approach developed to prepare individuals with alcohol use disorder (AUD) for confronting alcohol and associated stimuli in real life. CET has shown promise when treating AUD in group sessions, but it is unknown whether progressing from group sessions to using a mobile phone app is an effective delivery pathway.ObjectiveThe objectives of this study were to investigate (1) whether CET as aftercare would increase the effectiveness of primary treatment with cognitive behavior therapy, and (2) whether CET delivered through a mobile phone app would be similarly effective to CET via group sessions.MethodsA total of 164 individuals with AUD were randomized to one of three groups: CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual. Study outcomes were assessed face-to-face at preaftercare, postaftercare, and again at 6 months after aftercare treatment. Generalized mixed models were used to compare the trajectories of the groups over time on drinking, cravings, and use of urge-specific coping skills (USCS).ResultsIn all, 153 of 164 individuals (93%) completed assessments both at posttreatment and 6-month follow-up assessments. No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time. Both CET group (predicted mean difference 5.99, SE 2.59, z=2.31, P=.02) and the CET app (predicted mean difference 4.90, SE 2.26, z=2.31, P=.02) showed increased use of USCS compared to aftercare as usual at posttreatment, but this effect was reduced at the 6-month follow-up. No differences were detected between the two experimental CET groups on any outcomes.ConclusionsCET with USCS delivered as aftercare either via group sessions or a mobile phone app did not increase the effectiveness of primary treatment. This suggests that CET with USCS may not be an effective psychological approach for the aftercare of individuals treated for AUD.Trial registrationClinicalTrials.gov NCT02298751; https://clinicaltrials.gov/ct2/show/NCT02298751.

Project description:Background: Hallmarks of alcohol use disorder (AUD) are disturbances of circadian rhythms and everyday structures. While circadian rhythms dictate the timing of daily recurring activities such as sleep, activity, and meals, conversely, these activities represent time cues, so called Zeitgebers, that the circadian system uses to synchronize with the environment. Here we present a study protocol for our newly developed therapy approach for AUD patients, in which we take advantage of this mutual influence and stabilize and strengthen their circadian system by creating strict daily schedules for daily Zeitgeber activities. Since every person has a circadian system with its own characteristics and is subject to social obligations, the daily plans are personalized for each test person. Our hypothesis is that a regular exposure to Zeitgebers stabilizes behavioral and physiological circadian rhythms and thereby reduces the risk of alcohol relapses and depressive symptoms and facilitates physical recovery in AUD patients during the 1st weeks of their addiction therapy. Methods/design: The study is a 6-weeks single site trial with a controlled, randomized, single-blinded, parallel-group design including patients with a diagnosis of AUD. The study runs parallel to the standard addiction therapy of the clinic. Patients are randomly assigned to either an intervention group (DAILY) or a sham control group (placebo treatment). Questionnaires and physiological assessments of both groups are conducted before and immediately after the intervention or control treatment. According to our hypothesis, the primary outcomes of this study are improvements of regularity, alcohol consumption, and relapse rate in AUD patients compared to AUD patients receiving control treatment. Secondary outcomes are reduced depressive symptoms and increased physical recovery. Discussion: This study is a randomized controlled trial to investigate the efficacy of a personalized circadian Zeitgeber therapy as an adjunctive treatment for alcohol use disorder patients. The overall goal of this and more extended future studies is the development of an adjunctive therapy for AUD patients that is uncomplicated in its use and easy to implement in the clinical and everyday routine. Trial registration: This study is registered at the German Clinical Trial Register with the trial number DRKS00019093 on November 28, 2019.

Project description:BackgroundAlcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function.MethodsThis study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50 mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response.DiscussionThis study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment.Trial registrationClinicalTrials.gov NCT03594435 "Ibudilast for the Treatment of Alcohol Use Disorder". Registered on 20 July 2018.

Project description:BackgroundThe approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.MethodsThe study will be implemented as a randomized controlled trial. A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C) TAU only (control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Repeated-measures ANOVA will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to group C and that group B will achieve better outcomes than group A.DiscussionThis study is the first trial examining the effectiveness of stimuli-relevant AATP delivered in a VR environment. The use of VR has shown promise in enhancing the effectiveness of other psychological treatments and since AATP has already been shown effective as add-on treatment, it is of interest to investigate whether these effects can be further enhanced by implementing the program in more ecologically valid environments. If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment.Trial registrationClinicalTrials.gov ID: NCT04283305 Registration date: 24.02.20.

Project description:Background and aimsMost people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help to overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD.DesignRandomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n = 150) with face-to-face CBT (n = 151), at 3- and 6-month follow-ups.SettingA specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December 2015 and 5 January 2018.ParticipantsA total of 301 patients [mean age 50 years, standard deviation (SD) = 12.3] with AUD, of whom 115 (38%) were female and 186 (62%) were male.Intervention and comparatorParticipants were randomized in blocks of 20 at a ratio of 1 : 1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a 3-month period. The same treatment material and the same therapists were used in both groups.MeasurementsThe primary outcome was standard drinks of alcohol consumed during the previous week at 6-month follow-up, analysed according to intention-to-treat. The pre-specified non-inferiority limit was five standard drinks of alcohol and d = 0.32 for secondary outcomes.ResultsThe difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the 6-month follow-up [internet = 12.33 and face-to-face = 11.43, difference = 0.89, 95% confidence interval (CI) = -1.10 to 2.88]. The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at 6-month follow-up (internet = 12.26 and face-to-face = 11.57, d = 0.11, 95% CI = -0.11 to 0.34).ConclusionsInternet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.

Project description:AbstractAlcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n = 30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.Trial registrationNCT#03493958; registered 1 June 2018.

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A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

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A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

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