Kevin A. Hallgren

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

Background Mobile apps for mental health have the potential to overcome access barriers to mental health care, but there is little information on whether patients use the interventions as intended and the impact they have on mental health outcomes. Objective The objective of our study was to document and compare use patterns and clinical outcomes across the United States between 3 different self-guided mobile apps for depression. Methods Participants were recruited through Web-based advertisements and social media and were randomly assigned to 1 of 3 mood apps. Treatment and assessment were conducted remotely on each participant’s smartphone or tablet with minimal contact with study staff. We enrolled 626 English-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5, or if their score on item 10 was ≥2. The apps were (1) Project: EVO, a cognitive training app theorized to mitigate depressive symptoms by improving cognitive control, (2) iPST, an app based on an evidence-based psychotherapy for depression, and (3) Health Tips, a treatment control. Outcomes were scores on the PHQ-9 and the Sheehan Disability Scale. Adherence to treatment was measured as number of times participants opened and used the apps as instructed. Results We randomly assigned 211 participants to iPST, 209 to Project: EVO, and 206 to Health Tips. Among the participants, 77.0% (482/626) had a PHQ-9 score >10 (moderately depressed). Among the participants using the 2 active apps, 57.9% (243/420) did not download their assigned intervention app but did not differ demographically from those who did. Differential treatment effects were present in participants with baseline PHQ-9 score >10, with the cognitive training and problem-solving apps resulting in greater effects on mood than the information control app (χ22=6.46, P=.04). Conclusions Mobile apps for depression appear to have their greatest impact on people with more moderate levels of depression. In particular, an app that is designed to engage cognitive correlates of depression had the strongest effect on depressed mood in this sample. This study suggests that mobile apps reach many people and are useful for more moderate levels of depression. ClinicalTrial Clinicaltrials.gov NCT00540865; https://www.clinicaltrials.gov/ct2/show/NCT00540865 (Archived by WebCite at http://www.webcitation.org/6mj8IPqQr)

Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels

Background Alcohol use disorder (AUD) is a highly prevalent public health problem associated with considerable individual and societal costs. Abstinence from alcohol is the most widely accepted target of treatment for AUD, but it severely limits treatment options and could deter individuals who prefer to reduce their drinking from seeking treatment. Clinical validation of reduced alcohol consumption as the primary outcome of alcohol clinical trials is critical for expanding treatment options. One potentially useful measure of alcohol treatment outcome is a reduction in the World Health Organization (WHO, International Guide for Monitoring Alcohol Consumption and Related Harm. Geneva, Switzerland, 2000) risk levels of alcohol use (very high risk, high risk, moderate risk, and low risk). For example, a 2‐shift reduction in WHO risk levels (e.g., high risk to low risk) has been used by the European Medicines Agency (2010, Guideline on the Development of Medicinal Products for the Treatment of Alcohol Dependence. UK) to evaluate nalmefene as a treatment for alcohol dependence (AD; Mann et al. 2013, Biol Psychiatry 73, 706–13). Methods The current study was a secondary data analysis of the COMBINE study (n = 1,383; Anton et al., 2006) to examine the association between reductions in WHO risk levels and reductions in alcohol‐related consequences and mental health symptoms during and following treatment in patients with AD. Results Any reduction in WHO risk drinking level during treatment was associated with significantly fewer alcohol‐related consequences and improved mental health at the end of treatment and for up to 1 year posttreatment. A greater reduction in WHO risk drinking level predicted a greater reduction in consequences and greater improvements in mental health. Conclusions Changes in WHO risk levels appear to be a valid end point for alcohol clinical trials. Based on the current findings, reductions in WHO risk drinking levels during treatment reflect meaningful reductions in alcohol‐related consequences and improved functioning.

CACTI: Free, Open-Source Software for the Sequential Coding of Behavioral Interactions

The sequential analysis of client and clinician speech in psychotherapy sessions can help to identify and characterize potential mechanisms of treatment and behavior change. Previous studies required coding systems that were time-consuming, expensive, and error-prone. Existing software can be expensive and inflexible, and furthermore, no single package allows for pre-parsing, sequential coding, and assignment of global ratings. We developed a free, open-source, and adaptable program to meet these needs: The CASAA Application for Coding Treatment Interactions (CACTI). Without transcripts, CACTI facilitates the real-time sequential coding of behavioral interactions using WAV-format audio files. Most elements of the interface are user-modifiable through a simple XML file, and can be further adapted using Java through the terms of the GNU Public License. Coding with this software yields interrater reliabilities comparable to previous methods, but at greatly reduced time and expense. CACTI is a flexible research tool that can simplify psychotherapy process research, and has the potential to contribute to the improvement of treatment content and delivery.

Women with alcohol dependence: A randomized trial of couple versus individual plus couple therapy.

Couple therapy for women with alcohol use disorders (AUDs) yields positive drinking outcomes, but many women prefer individual to conjoint treatment. The present study compared conjoint cognitive-behavioral therapy (CBT) for women with AUDs to a blend of individual and conjoint therapy. Participants were 59 women with AUDs (95% Caucasian, mean age = 46 years) and their male partners randomly assigned to 12 sessions of Alcohol Behavioral Couple Therapy (ABCT) or to a blend of 5 individual CBT sessions and 7 sessions of ABCT (Blended-ABCT). Drinking and relationship satisfaction were assessed during and for 1-year posttreatment. Treatment conditions did not differ significantly on number of treatment sessions attended, percentage of drinking days (PDD), or percentage of heavy drinking days (PDH), during or in the 12 months following treatment. However, effect size estimates suggested a small to moderate effect of Blended-ABCT over ABCT in number of treatment sessions attended (d = -.41), and first- and second-half within treatment PDD (d = -.41, d = -.28), and PDH (d = -.46, d = -.38). Moderator analyses found that women lower in baseline sociotropy had lower PDH across treatment weeks 1-8 than in Blended-ABCT than ABCT and that women lower in self-efficacy had lower PDH during follow-up in Blended-ABCT than in ABCT. The 2 treatment groups did not differ significantly in within-treatment or posttreatment relationship satisfaction. Results suggest that blending individual and conjoint treatment yields similar or slightly better outcomes than ABCT, is responsive to womens expressed desire for individual sessions as part of their treatment, and decreases the challenges of scheduling conjoint sessions. (PsycINFO Database Record

Reproducibility and differential item functioning of the alcohol dependence syndrome construct across four alcohol treatment studies: An integrative data analysis

BACKGROUND The validity of the alcohol dependence syndrome has been supported. The question of whether different measures of the construct are comparable across studies and patient subgroups has not been examined. This study examined the alcohol dependence construct across four diverse large-scale treatment samples using integrative data analysis (IDA). METHOD We utilized existing data (n=4393) from the COMBINE Study, Project MATCH, the Relapse Replication and Extension Project (RREP), and the United Kingdom Alcohol Treatment Trial (UKATT). We focused on four measures of alcohol dependence: the Alcohol Dependence Scale (COMBINE and RREP), Alcohol Use Inventory (MATCH), the Leeds Dependence Questionnaire (UKATT), and the Diagnostic and Statistical Manual of Mental Disorders (COMBINE and MATCH). Moderated nonlinear factor analysis was used to create a measure of alcohol dependence severity that was moderated by study membership, gender, age, and marital status. RESULTS A commensurate measure of alcohol dependence severity was successfully created using 20 items available in four studies. We identified differential item functioning by study membership, age, gender, and/or marital status for 12 of the 20 items, indicating specific patient subgroups who responded differently to items based on their underlying dependence severity. CONCLUSIONS Alcohol dependence severity is a single unidimensional construct that is comparable across studies. The use of IDA provided a strong test of the validity of the alcohol dependence syndrome and clues as to how some items used to measure dependence severity may be more or less central to the construct for some patients.

Within-Provider Variability in Motivational Interviewing Integrity for Three Years after MI Training: Does Time Heal?

This study examined variability in Motivational Interviewing (MI) integrity among 15 providers for three years following training. Data come from an effectiveness trial in which providers were trained to deliver brief single-session MI interventions. Each session was audio-recorded and coded for MI integrity using the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 rating system. Within-provider variation in MI integrity was large, especially for behavior count scores (e.g., open questions, complex reflections) and only slightly smaller for global session scores of MI Spirit and Empathy. Within-provider variability was in most cases larger than between-provider variability and there was no evidence that providers improved appreciably over time. These findings raise concerns about the quality of MI being delivered in large-scale implementation efforts and have implications for the monitoring and training of higher quality MI.

Measurement error and outcome distributions: methodological issues in regression analyses of behavioral coding data

Behavioral coding is increasingly used for studying mechanisms of change in psychosocial treatments for substance use disorders (SUDs). However, behavioral coding data typically include features that can be problematic in regression analyses, including measurement error in independent variables, non normal distributions of count outcome variables, and conflation of predictor and outcome variables with third variables, such as session length. Methodological research in econometrics has shown that these issues can lead to biased parameter estimates, inaccurate standard errors, and increased Type I and Type II error rates, yet these statistical issues are not widely known within SUD treatment research, or more generally, within psychotherapy coding research. Using minimally technical language intended for a broad audience of SUD treatment researchers, the present paper illustrates the nature in which these data issues are problematic. We draw on real-world data and simulation-based examples to illustrate how these data features can bias estimation of parameters and interpretation of models. A weighted negative binomial regression is introduced as an alternative to ordinary linear regression that appropriately addresses the data characteristics common to SUD treatment behavioral coding data. We conclude by demonstrating how to use and interpret these models with data from a study of motivational interviewing. SPSS and R syntax for weighted negative binomial regression models is included in online supplemental materials.

Cultural adaptation, psychometric properties, and outcomes of the Native American Spirituality Scale.

Spirituality is central to many Native Americans (NAs) and has been associated with recovery from substance use disorders (SUDs). However, no published questionnaire uniquely taps tribal-specific spiritual beliefs and practices. This hinders efforts to integrate traditional NA spirituality into SUD treatment and track spiritual outcomes. As part of a randomized controlled trial examining SUD treatment for NAs, we adapted the Daily Spiritual Experience Scale (DSES) in collaboration with members of a Southwest tribe to create the Native American Spirituality Scale (NASS) and measured changes in the NASS over the course of treatment. The 83 participants (70% male) were from a single Southwest tribe and seeking SUD treatment. They completed the NASS at baseline, 4, 8, and 12 months. Exploratory factor analysis of the NASS was conducted and its temporal invariance, construct validity, and longitudinal changes in the factor and item scores were examined. The NASS yielded a 2-factor structure that was largely invariant across time. Factor 1 reflected behavioral practices, while Factor 2 reflected more global beliefs. Both factors significantly increased across 12 months, albeit at different assessment points. At baseline, Factor 1 was negatively related to substance use and positively associated with measures of tribal identification while Factor 2 was unrelated to these measures. Given the importance of tribal spirituality to many NAs, the development of this psychometrically sound measure is a key precursor and complement to the incorporation of tribal spirituality into treatment, as well as research on mechanisms of change for SUD treatment among NAs and assessment of NA spirituality in relation to other aspects of health.

Trajectories of Drinking Urges During Individual- and Couple-Based Cognitive-Behavioral Treatment for Alcohol Use Disorders

Individuals receiving treatment for alcohol use disorders (AUDs) often experience urges to drink, and reductions in drinking urges during cognitive-behavioral therapy (CBT) predict better treatment outcomes. However, little previous work has examined patterns of daily drinking urges during treatment. This study examined patterns of change in daily drinking urges among participants in two randomized clinical trials of males (N = 80 with 4,401 daily recordings) and females ( N = 101 with 8,011 daily recordings) receiving individual- or couples-based CBT. Drinking urges were common during treatment, occurring on 45.1% of days for men and 44.8% for women. Drinking urges and alcohol use for both genders decreased substantially during the course of treatment. Both genders had increases in drinking urges as more time elapsed since attending a treatment session. For men, this increase was most pronounced at the beginning of treatment, but for women it was most pronounced near the end of treatment. Alcohol use and drinking urges were both more likely to occur on weekends. The results suggest that these times may lead to higher risk for drinking, and clients may benefit from high-risk planning that is focused on these times.

Prediction of Suicide Ideation and Attempt Among Substance-Using Patients in Primary Care

Background: Suicide is a major public health concern, particularly among people who use illicit substances and/or non-prescribed medications. Methods: The present study prospectively assessed the incidence and predictors of suicidal ideation (SI) and suicide attempt (SA) among 868 substance-using patients over 12 months after receiving primary care within seven public primary care clinics. Results: Participants reported a high incidence of SI (25.9%) and SA (7.1%) over the year following primary care visits. Suicidality was elevated in patients who were female; lacked a high school diploma; were unemployed; reported depression, anxiety, hallucinations, concentration difficulty, or violent behavior; used nicotine or stimulants; used the emergency department or mental health services in the past 90 days; reported current quality-of-life impairment in mobility or usual activities; or reported recent SI or lifetime SA at baseline. In multiple regression analyses, only past 30-day SI, any lifetime SA, past 90-day violent behavior, and current impairment due to anxiety or depression at baseline uniquely predicted SI or SA beyond other variables. Conclusions: Results support the need for screening for suicidality among primary care patients who use illicit substances and identify key subgroups of these patients who are at particularly elevated risk for suicidality.