scholarly journals Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
J.Todd Arnedt ◽  
Libby Hobson ◽  
Deirdre A. Conroy ◽  
Mandilyn Graham ◽  
Sajni Amin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alcohol Use ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Post Treatment ◽  
Treatment Seeking ◽  
Randomized Controlled ◽  
Sleep Homeostasis ◽  
Hygiene Education ◽  
The Impact

Abstract Background: Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes. Methods: This is a single-site randomized controlled trial with planned enrollment of 150 adults meeting criteria for both AUD and chronic insomnia. Eligible participants will be randomized 1:1 to 6 weeks of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) or Sleep Hygiene Education (SHE-TM) with clinical assessments conducted at pre-treatment, post- treatment, and at 3-, 6-, and 12-months post-treatment. Overnight polysomnography will be conducted before and after treatment. Primary clinical outcomes will include post-treatment scores on the Insomnia Severity Index and the General Fatigue subscale of the Multidisciplinary Fatigue Inventory, and the percent of days abstinent (PDA) on the interview-administered Time Line Follow Back. EEG delta activity, derived from overnight polysomnography, will be the primary endpoint to assess the sleep homeostasis mechanism. Discussion: This adequately powered randomized controlled trial will provide clinically-relevant information about whether targeting insomnia is effective for improving treatment outcomes among treatment-seeking adults with AUD. Additionally, the study will offer new scientific insights on the impact of an evidence-based non-medication treatment for insomnia on a candidate mechanism of sleep dysfunction in this population - sleep homeostasis.Registration: NCT, NCT # 04457674. Registered 07 July 2020, https://clinicaltrials.gov/ct2/show/NCT04457674?cond=alcohol+use&cntry=US&state=US%3AMI&draw=2&rank=1

Alcohol Use Disorder and Comorbid Depression: A Randomized Controlled Trial Investigating the Effectiveness of Supportive Text Messages in Aiding Recovery

2019 ◽  
Vol 54 (5) ◽  
pp. 551-558 ◽  
Author(s):  
Helen O’Reilly ◽  
Aisling Hagerty ◽  
Seamus O’Donnell ◽  
Aoife Farrell ◽  
Dan Hartnett ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Controlled Trial ◽  
Text Messages ◽  
Comorbid Depression ◽  
Randomized Controlled ◽  
Lower Alcohol ◽  
The Impact

This randomized controlled trial examined the impact of daily supportive text messages over a six-month treatment period on mood and alcohol consumption in individuals with a dual diagnosis of alcohol use disorder (AUD) and depression. Results highlighted mood benefits at 3-month and lower alcohol consumption at 6-month treatment points.

scholarly journals Feasibility, Acceptability, and Preliminary Efficacy of an Automated Conversational Agent for Reducing Problematic Substance Use (Preprint)

2020 ◽  
Author(s):  
Judith Prochaska ◽  
Erin Alyssa Vogel ◽  
Amy Chieng ◽  
Matthew Kendra ◽  
Michael Baiocchi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Substance Use ◽  
Dialectical Behavior Therapy ◽  
Behavioral Therapy ◽  
Digital Health ◽  
Controlled Trial ◽  
Post Treatment ◽  
Future Research ◽  
Randomized Controlled ◽  
Problematic Substance

BACKGROUND Misuse of substances is common, can be serious and costly to society, and often goes untreated due to barriers accessing care. Digital health programs offer greater public health reach. Woebot is a mental health digital solution informed by Cognitive Behavioral Therapy and built upon an artificial intelligence (AI) driven platform to deliver tailored content to users. In a prior 2-week randomized controlled trial, Woebot alleviated depressive symptoms. OBJECTIVE We adapted Woebot for the treatment of substance use disorders (W-SUDs), adding elements from Dialectical Behavior Therapy and Motivational Interviewing. W-SUDs is an 8-week program with mood, craving, and pain tracking and modules (psychoeducational lessons and psychotherapeutic skills/tools). In a single-group pre/post design, we report on feasibility, acceptability, and preliminary efficacy of W-SUDs. METHODS Adults (ages 18-65 years) residing in the US who screened positive on the CAGE-AID (2+) without major health contraindications were enrolled March 27 - May 6, 2020. Enrollment (N=101) doubled the recruitment goal. The sample averaged 36.8 years of age (SD 10.0); 75.2% were female; 78.2% non-Hispanic White; and 72.3% employed. Most (68.3%) identified alcohol as their primary problematic substance, followed by cannabis (19.8%); 36.7% identified multiple problematic substances; and 72.3% reported a lifetime mental illness. Nearly all (98.0%) were sheltering-in-place with the COVID-19 pandemic. RESULTS Participants’ use of W-SUDs averaged 15.7 (SD 14.2) days, 12.1 (SD=8.3) modules, and 600.7 (SD 556.5) sent messages; 94.0% (562/598) of completed psychoeducational lessons were rated positively. From treatment start to end, in-app craving ratings were reduced by half (87/101 reporting; OR 0.48, 95% CI 0.32-0.73). Post-treatment assessment completion was 50% (n=51), with retention better among those who initially screened higher on the CAGE-AID. From pre- to post-treatment, confidence to resist urges to use significantly increased (mean 46.0, SD 19.3 to mean 62.8, SD 22.4) and past-month substance use occasions (mean 29.5, SD 14.0 to mean 20.1, SD 17.8), AUDIT-C (mean 5.3, SD 2.9 to mean 4.0, SD 3.2), DAST-10 (mean 2.9, SD 2.7 to mean 1.7, SD 2.4), PHQ-8 depression (mean 10.7, SD 5.3 to mean 8.6, SD 5.1), and GAD-7 anxiety (mean 10.1, SD 5.7 to mean 7.8, SD 5.3), and cravings (68.6% vs. 47.1% moderate-to-extreme) significantly decreased (all p-values<.05). Most would recommend W-SUDs to a friend (39/51, 76%) and received service they desired (41/51, 80%). Fewer felt W-SUDs met most/all of their needs (22/51, 43%). The one serious adverse event (hospitalization) was deemed unrelated to study participation. CONCLUSIONS W-SUDs was feasible to deliver, engaging, and acceptable; and associated with significant improvements in substance use, confidence, cravings, depression, and anxiety. Study attrition was high. Future research will evaluate W-SUDs in a randomized controlled trial with a more diverse sample and with use of greater strategies for study retention. CLINICALTRIAL NCT04096001

scholarly journals Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna L. MacKinnon ◽  
Joshua W. Madsen ◽  
Ashley Dhillon ◽  
Elizabeth Keys ◽  
Gerald F. Giesbrecht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Sleep Problems ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
The Impact ◽  
In Pregnancy

Abstract Background Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). Methods A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). Discussion CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. Trial registration ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

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