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Randomized Controlled Trial
. 2024 Sep 3;7(9):e2435205.
doi: 10.1001/jamanetworkopen.2024.35205.

A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial

Brian D Kiluk  1 , Bryan Benitez  1 , Elise E DeVito  1 , Tami L Frankforter  1 , Donna M LaPaglia  1 , Stephanie S O'Malley  1 , Charla Nich  1
Affiliations
Randomized Controlled Trial

A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial

Brian D Kiluk et al. JAMA Netw Open. .

Abstract

Importance: Cognitive behavioral therapy (CBT) is an evidence-based treatment for alcohol use, yet patient access is limited and may be enhanced through digital therapeutics.

Objective: To evaluate the efficacy of a digital CBT program (Computer-Based Training for Cognitive Behavioral Therapy [CBT4CBT]) or clinician-delivered CBT compared with standard treatment for reducing alcohol use.

Design, setting, and participants: A 3-arm randomized clinical trial was conducted at outpatient substance use treatment facilities in Connecticut between February 14, 2017, and December 31, 2021, that included an 8-week treatment period with a 6-month follow-up period. Treatment-seeking adults were included who met criteria for current alcohol use disorder and reported drinking at least 14 (men) or 7 (women) drinks per week in the past month and were sufficiently stable for outpatient treatment.

Interventions: Participants were randomly assigned to 1 of the following groups: (1) treatment as usual (TAU) consisting of weekly group or individual counseling, (2) CBT delivered weekly by trained and fidelity-monitored clinicians, or (3) web-based CBT plus brief weekly clinical monitoring.

Main outcomes and measures: Rates of alcohol use were measured weekly during the treatment period and at 1-, 3-, and 6-month follow-up using the timeline follow-back method. The primary outcome was the percentage of days abstinent (PDA) from alcohol per month. Intention-to-treat analyses were conducted.

Results: Of the 99 randomized participants (mean [SD] age, 45.5 [12.7]), 66 were male (66.7%); 39 identified as Black/African American (39.8%), 19 (19.2%) as Hispanic, and 47 (48.0%) as White. Mean (SD) rates of PDA from baseline to 6-month follow-up were 49.3% (27.8%) to 69.6% (34.4%) for TAU; 53.7% (29.8%) to 70.2% (35.1%) for CBT; and 47.6% (31.8%) to 82.6% (25.3%) for digital CBT. Results of random-effects regression showed a significant increase in PDA during the study period, with those assigned to digital CBT increasing PDA at a faster rate than TAU (t733 = 2.55; P = .01) and CBT (t733 = 3.36; P < .001). However, there was no statistically significant difference between treatment groups during the 8-week treatment period.

Conclusions and relevance: In this randomized clinical trial, while there was no significant difference between treatment groups during the 8-week treatment period, there was differential change between treatments during the 8-month study period that provides support for the efficacy of this digital CBT program.

Trial registration: ClinicalTrials.gov Identifier: NCT02742246.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kiluk reported receiving grants from the National Institutes of Health National Institute on Alcohol Abuse and Alcoholism (NIH/NIAAA) during the conduct of the study and personal fees from CBT4CBT LLC outside the submitted work. Dr Benitez reported receiving grants from the NIH/NIAAA during the conduct of the study. Dr O'Malley reported receiving grants from the NIH/NIAAA during the conduct of the study; personal fees from the American Society of Clinical Psychopharmacology supported by Alkermes, Dicerna, Ethypharm, Pear Therapeutics, and Kinnov Therapeutics; nonfinancial support from Novartis (study medication), Stalicla (study medication), and Amygdala (study medication); personal fees from Dicerna; and personal fees from the University of New Mexico (consultant on NIH grant) outside the submitted work; in addition, Dr O'Malley had a patent for Mavoglurant for gambling disorder with Yale and Novartis pending. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participant Flow
CBT indicates cognitive behavioral therapy; CBT4CBT, Computer-Based Training for Cognitive Behavioral Therapy; TAU, treatment as usual.
Figure 2.
Figure 2.. Percentage of Days Abstinent (PDA) From Alcohol by Month During Study Period
Lines represent slope of change in PDA by month; shaded areas represent 95% CIs. CBT indicates cognitive behavioral therapy; CBT4CBT, Computer-Based Training for Cognitive Behavioral Therapy; TAU, treatment as usual.
See this image and copyright information in PMC

Comment in

References

    1. Rehm J, Shield KD. Global burden of disease and the impact of mental and addictive disorders. Curr Psychiatry Rep. 2019;21(2):10. doi: 10.1007/s11920-019-0997-0 - DOI - PubMed
    1. Magill M, Ray L, Kiluk B, et al. A meta-analysis of cognitive-behavioral therapy for alcohol or other drug use disorders: treatment efficacy by contrast condition. J Consult Clin Psychol. 2019;87(12):1093-1105. doi: 10.1037/ccp0000447 - DOI - PMC - PubMed
    1. American Psychiatric Association . Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. American Psychiatric Association; 2018.
    1. McHugh RK, Barlow DH. The dissemination and implementation of evidence-based psychological treatments: a review of current efforts. Am Psychol. 2010;65(2):73-84. doi: 10.1037/a0018121 - DOI - PubMed
    1. Emmelkamp PM, David D, Beckers T, et al. Advancing psychotherapy and evidence-based psychological interventions. Int J Methods Psychiatr Res. 2014;23(suppl 1)(suppl 1):58-91. doi: 10.1002/mpr.1411 - DOI - PMC - PubMed

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