A Descriptive Review and Meta-Regression Study of Demographic and Study Context Factors in US Clinical Trials of Cognitive Behavioral Interventions for Alcohol or Other Drug Use

Abstract

Objectives. Cognitive-Behaviorally Based Interventions (CBIs) are evidence-based treatments for alcohol and other drug (AOD) use with potential variable effectiveness by population sub-groups. This study used evidence synthesis to examine treatment effect by demographic and study context factors in clinical trials of CBI for AOD. Methods. Studies were systematically identified, and their characteristics and outcome data were extracted and summarized. Standardized mean differences were calculated for within- and between-condition effects on substance use outcomes. Demographic and study context moderators were identified during data acquisition and several sensitivity analyses were conducted. Results. The sample included K = 29 trials and a total of 15 study-level moderators were examined. Information on participants’ age, biological sex, and race were reported in at least 26 trials, but information on gender identity, sexual orientation, and ethnicity were reported infrequently or in non-inclusive ways. The mean between-condition effect size was small and moderately heterogenous (d = 0.158, 95% CI = 0.079, 0.238, I² = 46%) and the mean within-condition effect size was large and showed high heterogeneity (d_z = 1.147, 95% CI = 0.811, 1.482, - I² = 96%). The specific drug targeted in the study and whether biological assay-based outcomes were used moderated between-condition CBI efficacy and the inclusion of co-occurring mental health conditions and study publication date moderated within-condition CBI effects. Conclusions. Results provide preliminary data on study context factors associated with effect estimates in United States based clinical trials of CBI for AOD.

Keywords:

• Meta-analysis
• demographic representation
• addiction
• relapse prevention

Declaration of interest

The authors declare that they have no conflict of interest. The authors alone are responsible for the content and writing of the article.

Notes

1 The 11 symptoms are hazardous use, social and interpersonal problems related to use, neglecting major roles, withdrawal, tolerance, using larger amounts/longer, repeated attempts to control use/quit, much time spent using, physical or psychological problems related to use, activities given up to use, and craving (American Psychiatric Association, 2013). Displaying 2-3 symptoms indicates mild AUD/SUD, 4-5 indicate moderate AUD/SUD, and 6 or more indicates severe AUD/SUD, which is synonymous with addiction (American Psychiatric Association, 2013).

2 Sex is a biological concept that describes differences within organisms related to reproductive, physiological, neuroendocrine, behavioral, and metabolic systems (Tannenbaum et al., 2019). Gender in comparison is psychologically, socially, and culturally constructed. Gender shapes attitudes, behaviors, and stereotypes and encompasses the interrelated concepts of gender norms, identity, and relations (Tannenbaum et al., 2019). In the majority of studies in the public and medical literature, these two variables are not distinguished when recruiting participants (Lynn-Green et al., 2023).

3 Based on institute-approved grant protocol.

4 Only one study (Thornton et al., 2003) provided late follow up data.

5 Biological assay measures were selected to facilitate objective outcome measurement, although concordance between these indicators and self-report has been shown to be high (Bharat et al., 2023).

Additional information

Funding

This research was supported by R01 AA029703 Awarded to Molly Magill. This work is the sole responsibility of the authors and does not reflect official positions of the National Institutes of Health.