Dataset Information

DAILY-A Personalized Circadian Zeitgeber Therapy as an Adjunctive Treatment for Alcohol Use Disorder Patients: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Huhne A

PROVIDER: S-EPMC7840704 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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DAILY-A Personalized Circadian Zeitgeber Therapy as an Adjunctive Treatment for Alcohol Use Disorder Patients: Study Protocol for a Randomized Controlled Trial.

Hühne Anisja A Hoch Eva E Landgraf Dominic D

Frontiers in psychiatry 20210114

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 ...[more]

PMID: 33519541

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Project description:AimsTo examine whether physical activity as an adjunct to outpatient alcohol treatment has an effect on alcohol consumption following participation in an exercise intervention of six months' duration, and at 12 months after treatment initiation.MethodsThe study is a randomized controlled study with three arms: Patients allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise, (C) treatment as usual and individual physical exercise. The primary outcome measure was excessive drinking six months after treatment start and completion of the intervention. A logistic regression model was used to evaluate the odds of excessive drinking among the three groups, based on intention-to-treat. Changes in level of physical activity in all three groups were tested by using a generalized linear mixed model. A multiple linear model was used to test if there was an association between amount of performed physical activity and alcohol consumption.ResultsA total of 175 patients (68.6% male) participated. Response rates were 77.7% at six months and 57.1% at 12 months follow-up. OR 0.99 [95% CI: 0.46; 2.14], p = 0.976 for excessive drinking in the group exercise condition, and 1.02 [95% CI: 0.47; 2.18], p = 0.968 in the individual exercise condition, which, when compared to the control group as reference, did not differ statistically significantly. Participants with moderate level physical activity had lower odds for excessive drinking OR = 0.12 [0.05; 0.31], p<0.001 than participants with low level physical activity. Amount of alcohol consumption in the intervention groups decreased by 4% [95% CI: 0.03; 6.8], p = 0.015 for each increased exercising day.ConclusionsNo direct effect of physical exercise on drinking outcome was found. Moderate level physical activity was protective against excessive drinking following treatment. A dose-response effect of exercise on drinking outcome supports the need for implementing physically active lifestyles for patients in treatment for alcohol use disorder.

Project description:BackgroundIt 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.Design and methodsThe 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).DiscussionIndividuals 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.Trial registrationClinicalTrials.gov ID: NCT02298751 Registration date: 6 November 2014.

Project description:BackgroundAlcohol use disorder (AUD) is highly prevalent and commonly co-occurs with other psychiatric disorders among Veterans. Provisional evidence supports the use of Approach Avoidance Training (AAT) - a form of computer-delivered cognitive bias modification designed to target implicit approach bias for alcohol-related cues - as an adjunctive program to treat AUD. However, the extent to which AAT is effective for improving AUD recovery outcomes in outpatient Veteran samples and those with psychiatric comorbidities has been understudied to date. Here we describe a double-blind randomized controlled trial of AAT versus a comparison condition (Sham) being conducted in Veterans with comorbid psychiatric conditions completing outpatient standard care.MethodsOne hundred thirty-six Veterans currently receiving outpatient treatment for AUD will be recruited for this randomized controlled trial with parallel group assignment. Participants will be randomized to either 6 weeks of AAT (n = 68) or Sham (n = 68) training in conjunction with usual care. Assessments will occur at baseline and 6 weeks, 3 months, and 6 months post-baseline. Primary outcome variables will include functional consequences of drinking. Secondary outcome variables will include alcohol consumption, and behavioral indicators of alcohol approach bias. A subset of participants (n = 51) will also complete functional magnetic resonance imaging (fMRI) to assess neural response during an alcohol approach bias assessment.DiscussionThis study is the first randomized controlled trial of AAT administered as an adjunctive treatment to standard care in Veterans with AUD and comorbid psychiatric disorders. Additionally, behavioral and neuroimaging data will be used to determine the extent to which AAT targets approach bias for alcohol cues. If effective, AAT may be a promising low-cost adjunctive treatment option for individuals with AUD.Registry nameAAT for Alcohol Use Disorder in Veterans.Trial registrationClinicalTrials.gov: NCT05372029; Date of Registration: 5/9/2022.

Project description:BackgroundOpioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed.ObjectiveTo this end, we describe the development of the novel digital therapeutic MODIA.MethodsMODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing.ResultsMODIA uses proprietary software that dynamically tailors content to the users' responses. The MODIA program comprises 24 modules or "chats" that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a "simulated dialogue" experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction.ConclusionsAs part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients.

Dataset Information

DAILY-A Personalized Circadian Zeitgeber Therapy as an Adjunctive Treatment for Alcohol Use Disorder Patients: Study Protocol for a Randomized Controlled Trial.

Publications

DAILY-A Personalized Circadian <i>Zeitgeber</i> Therapy as an Adjunctive Treatment for Alcohol Use Disorder Patients: Study Protocol for a Randomized Controlled Trial.

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