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Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

ABSTRACT: INTRODUCTION:Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. METHODS AND ANALYSIS:The present study is a single-blind randomised controlled trial. Patients aged 18-70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12?months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. ETHICS AND DISSEMINATION:The trial has received full ethical approval from the St. Patrick's Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. TRIAL REGISTRATION NUMBER:NCT02404662; Pre-results.

SUBMITTER: Hartnett D

PROVIDER: S-EPMC5729994 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

Hartnett Dan D Murphy Edel E Kehoe Elizabeth E Agyapong Vincent V McLoughlin Declan M DM Farren Conor C

BMJ open 20170529 5

<h4>Introduction</h4>Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mo ...[more]

PMID: 28554910

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Project description:BACKGROUND:Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost-effective and technologically-based therapies including the use of supportive text messages. OBJECTIVE:To determine the feasibility and effectiveness of supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure. METHODS:This will be a longitudinal, prospective, parallel-design, two-arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant, with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomized from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study. RESULTS:The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention, will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial. CONCLUSIONS:The paradigm for behavior change using text messages as a patient-direct intervention is consistent with a cognitive behavior therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard-to-reach areas with limited access to psychological therapies. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02327858; https://clinicaltrials.gov/ct2/show/NCT02327858 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02327858).

Project description:ImportanceAlcohol dependence (AD) and major depression (MD) are leading causes of disability that often co-occur. Genetic epidemiologic data have shown that AD and MD share a common possible genetic cause. The molecular nature of this shared genetic basis is poorly understood.ObjectivesTo detect genetic risk variants for comorbid AD and MD and to determine whether polygenic risk alleles are shared with neuropsychiatric traits or subcortical brain volumes.Design, setting, and participantsThis genome-wide association study analyzed criterion counts of comorbid AD and MD in African American and European American data sets collected as part of the Yale-Penn study of the genetics of drug and alcohol dependence from February 14, 1999, to January 13, 2015. After excluding participants never exposed to alcohol or with missing information for any diagnostic criterion, genome-wide association studies were performed on 2 samples (the Yale-Penn 1 and Yale-Penn 2 samples) totaling 4653 African American participants and 3169 European American participants (analyzed separately). Tests were performed to determine whether polygenic risk scores derived from potentially related traits in European American participants could be used to estimate comorbid AD and MD.Main outcomes and measuresComorbid criterion counts (ranging from 0 to 14) for AD (7 criteria) and MD (9 criteria, scaled to 7) as defined by the DSM-IV.ResultsOf the 7822 participants (3342 women and 4480 men; mean [SD] age, 40.1 [10.7] years), the median comorbid criterion count was 6.2 (interquartile range, 2.3-10.9). Under the linear regression model, rs139438618 at the semaphorin 3A (SEMA3A [OMIM 603961]) locus was significantly associated with AD and MD comorbidity in African American participants in the Yale-Penn 1 sample (β = 0.89; 95% CI, 0.57-1.20; P = 2.76 × 10-8). In the independent Yale-Penn 2 sample, the association was also significant (β = 0.83; 95% CI, 0.39-1.28; P = 2.06 × 10-4). Meta-analysis of the 2 samples yielded a more robust association (β = 0.87; 95% CI, 0.61-1.12; P = 2.41 × 10-11). There was no significant association identified in European American participants. Analyses of polygenic risk scores showed that individuals with a higher risk of neuroticism (β = 1.01; 95% CI, 0.50-1.52) or depressive symptoms (β = 0.87; 95% CI, 0.32-1.42) and a lower level of subjective well-being (β = -0.94; 95% CI, -1.46 to -0.42) and educational attainment (β = -1.00, 95% CI, -1.57 to -0.44) had a higher level of AD and MD comorbidity, while larger intracranial (β = 1.07; 95% CI, 0.50 to 1.64) and smaller putamen volumes (β = -1.16; 95% CI, -1.86 to -0.46) were associated with higher risks of AD and MD comorbidity.Conclusions and relevanceSEMA3A variation is significantly and replicably associated with comorbid AD and MD in African American participants. Analyses of polygenic risk scores identified pleiotropy with neuropsychiatric traits and brain volumes. Further studies are warranted to understand the biological and genetic mechanisms of this comorbidity, which could facilitate development of medications and other treatments for comorbid AD and MD.

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.

Dataset Information

Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

Publications

Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

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