Feasibility and Acceptability of an Intervention Providing Computer-Generated Tailored Feedback to Target Alcohol Consumption and Depressive Symptoms in Proactively Recruited Health Care Patients and Reactively Recruited Media Volunteers: Results of a Pilot Study.

BACKGROUND: A pre-post pilot study was conducted to test the feasibility, acceptability, and potential effectiveness of a fully automatized computer-based intervention targeting hazardous drinking and depressiveness in proactively recruited health care patients (HCPs). To address the importance of the sample selection when testing interventions, HCPs were compared to media recruited volunteers (MVs). METHOD: In a multicenter screening program 2,773 HCPs were screened for hazardous drinking and depressive symptoms. MVs were recruited via media solicitation. Over a period of 6 months, study participants received 6 individualized counseling letters and weekly short messages. Pre-post data were analyzed for 30 participants (15 HCPs, 15 MVs). Intervention acceptability was assessed in post-intervention interviews conducted with 32 study participants. RESULTS: MVs showed higher problem severity and motivation to change than HCPs. Over the course of the intervention both subsamples reduced regular binge drinking (HCPs: p = 0.016; MVs: p = 0.031) and depressiveness (HCPs: p = 0.020; MVs: p < 0.001). MVs further reduced average daily alcohol consumption (p = 0.034). The intervention received positive ratings from both subsamples, the alcohol module was rated more favorably by MVs than by HCPs (p = 0.012). Subsamples further differed in terms of intervention usage (p = 0.013). CONCLUSION: The intervention was technically and logistically feasible, well accepted, and may have the potential to reduce hazardous drinking and depressive symptoms in different populations. Subsamples differed in terms of problem severity, motivation to change, intervention usage, pre-post changes, and attitudes toward the intervention, showing that intervention development should involve the intended target populations to avoid biased conclusions on intervention effectiveness and acceptability.

Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial.

Worldwide, more than eight million people die each year as a result of tobacco use. A large proportion of smokers who want to quit are interested in alternative smoking cessation methods, of which hypnotherapy is the most popular. However, the efficacy of hypnotherapy as a tobacco cessation intervention cannot be considered sufficiently proven due to significant methodological limitations in the studies available to date. The aim of the present study was to compare the efficacy of a hypnotherapeutic group program for smoking cessation with that of an established cognitive-behavioral group program in a randomized controlled trial. A total of 360 smokers who were willing to quit were randomly assigned to either hypnotherapy (HT) or cognitive-behavioral therapy (CBT) at two study sites, without regard to treatment preference. They each underwent a 6 weeks smoking cessation course (one 90 min group session per week) and were followed up at regular intervals over a 12 months period. The primary outcome variable was defined as continuous abstinence from smoking according to the Russell standard, verified by a carbon monoxide measurement at three measurement time points. Secondary outcome variables were 7 days point prevalence abstinence during the 12 months follow up and the number of cigarettes the non-quitters smoked per smoking day (smoking intensity). Generalized estimating equations were used to test treatment condition, hypnotic suggestibility, and treatment expectancy as predictors of abstinence. The two interventions did not differ significantly in the proportion of participants who remained continuously abstinent throughout the follow-up period (CBT: 15.6%, HT: 15.0%) and also regarding the 7 days abstinence rates during the 12 months follow-up (CBT: 21.2%, HT: 16.7%). However, when controlling for hypnotic suggestibility, CBT showed significantly higher 7 days abstinence rates. In terms of the continuous abstinence rates, it can be concluded that the efficacy of hypnotherapeutic methods for smoking cessation seem to be comparable to established programs such as CBT. Clinical trial registration: ClinicalTrials.gov, identifier NCT01129999.

Association between Alcohol Consumption and Health-Related Quality of Life among Hospital and Ambulatory Care Patients with Past Year Depressive Symptoms.

BACKGROUND: Little is known about how substance use affects health-related quality of life (HRQOL) in depressed individuals. Here, associations between alcohol consumption and HRQOL in hospital and ambulatory care patients with past-year depressive symptoms are analyzed. METHOD: The sample consisted of 590 participants (26.8% non-drinkers) recruited via consecutive screenings. Individuals with alcohol use disorders were excluded. HRQOL was assessed with the Veterans Rand 12-item health survey (VR-12). Multivariable fractional polynomials (MFP) regression analyses were conducted (1) to test for non-linear associations between average daily consumption and HRQOL and (2) to analyze associations between alcohol consumption and the physical and mental health component summaries of the VR-12 and their subdomains. RESULTS: Alcohol consumption was positively associated with the physical health component summary of the VR-12 (p = 0.001) and its subdomains general health (p = 0.006), physical functioning (p < 0.001), and bodily pain (p = 0.017), but not with the mental health component summary (p = 0.941) or any of its subdomains. Average daily alcohol consumption was not associated with HRQOL. CONCLUSION: Alcohol consumption was associated with better physical HRQOL. Findings do not justify ascribing alcohol positive effects on HRQOL. Data indicate that non-drinkers may suffer from serious health disorders. The results of this study can inform the development of future alcohol- and depression-related interventions.

German Norms of the Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A) and Proposal of a 5-Item Short-Version (HGSHS-5:G).

The Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A), is commonly used to test hypnotizability. There is still some controversy about what exactly hypnotizability is and whether and how it can be measured, especially by the HGSHS:A. Furthermore, a wider clinical use is limited, requiring a testing time of more than 1 hour. We analyzed the German HGSHS:A version for its factorial structure, item contribution, and item difficulty based on test data from six studies, including 1276 persons, to propose a shorter version of the HGSHS:A. We hereby present a 5-item version of the HGSHS:A (HGSHS-5:G), consisting of the challenge items, that was compared with an 11-item version (highly variable posthypnotic amnesia omitted). Age- and gender-specific norms was generated. The HGSHS-5: G showed high validity, reliability, and classification agreement. It reduces test time to 30 minutes thus facilitating wider use of hypnotizability testing.

Copattern of depression and alcohol use in medical care patients: cross-sectional study in Germany.

OBJECTIVE: To predict depressive symptom severity and presence of major depression along the full alcohol use continuum. DESIGN: Cross-sectional study. SETTING: Ambulatory practices and general hospitals from three sites in Germany. PARTICIPANTS: Consecutive patients aged 18-64 years were proactively approached for an anonymous health screening (participation rate=87%, N=12 828). Four continuous alcohol use measures were derived from an expanded Alcohol Use Disorder Identification Test (AUDIT): alcohol consumption in grams per day and occasion, excessive consumption in days per months and the AUDIT sum score. Depressive symptoms were assessed for the worst 2-week period in the last 12 months using the Patient Health Questionnaire (PHQ-8). Negative binomial and logistic regression analyses were used to predict depressive symptom severity (PHQ-8 sum score) and presence of major depression (PHQ-8 sum score≥10) by the alcohol use measures. RESULTS: Analyses revealed that depressive symptom severity and presence of major depression were significantly predicted by all alcohol use measures after controlling for sociodemographics and health behaviours (p<0.05). The relationships were curvilinear: lowest depressive symptom severity and odds of major depression were found for alcohol consumptions of 1.1 g/day, 10.5 g/occasion, 1 excessive consumption day/month, and those with an AUDIT score of 2. Higher depressive symptom severity and odds of major depression were found for both abstinence from and higher levels of alcohol consumption. Interaction analyses revealed steeper risk increases in women and younger individuals for most alcohol use measures. CONCLUSION: Findings indicate that alcohol use and depression in medical care patients are associated in a curvilinear manner and that moderation by gender and age is present.

Use of Real-Time Functional Magnetic Resonance Imaging-Based Neurofeedback to Downregulate Insular Cortex in Nicotine-Addicted Smokers.

It has been more than a decade since the first functional magnetic resonance imaging (fMRI)-based neurofeedback approach was successfully implemented. Since then, various studies have demonstrated that participants can learn to voluntarily control a circumscribed brain region. Consequently, real-time fMRI (rtfMRI) provided a novel opportunity to study modifications of behavior due to manipulation of brain activity. Hence, reports of rtfMRI applications to train self-regulation of brain activity and the concomitant modifications in behavioral and clinical conditions such as neurological and psychiatric disorders [e.g., schizophrenia, obsessive compulsive Disorder (OCD), stroke] have rapidly increased. Neuroimaging studies in addiction research have shown that the anterior cingulate cortex, orbitofrontal cortex, and insular cortex are activated during the presentation of drug-associated cues. Also, activity in both left and right insular cortices have been shown to be highly correlated with drug urges when participants are exposed to craving-eliciting cues. Hence, the bilateral insula is of particular importance in researching drug urges and addiction due to its role in the representation of bodily (interoceptive) states. This study explores the use of rtfMRI neurofeedback for the reduction in blood oxygen-level dependent (BOLD) activity in bilateral insular cortices of nicotine-addicted participants. The study also tests if there are neurofeedback training-associated modifications in the implicit attitudes of participants towards nicotine-craving cues and explicit-craving behavior.

Proactive multipurpose health risk screening in health care settings: Methods, design, and reach.

OBJECTIVES: Real world implementation of proactive screening and brief intervention in health care is threatened by high cost. Using e-health interventions and screening for multiple health risk factors may provide more efficiency. We describe methodological details of a proactive multipurpose health risk screening in health care settings and report on participation rates, participants' characteristics, and participation factors. METHODS: Patients between 18 and 64 years from ambulatory practices and hospitals were proactively approached by study assistants at three sites for a computerized screening on harmful alcohol and tobacco consumption, depressive symptoms, insufficient fruit/vegetable consumption, physical inactivity and overweight. On the basis of their health risk pattern, a computerized algorithm allocated patients to one of five studies each of them addressing a psychiatric research question. RESULTS: Among all eligible patients, 13,763 (86.5%) were screened. Younger age and being female predicted screening participation. Of those with complete data (n = 12,828), 82.9% reported at least two health risks and 34.0% were eligible for a study. Study participation ranged between 35.2% and 50.8%, and was associated with socio-demographics and problem severity. CONCLUSIONS: This study supports the use of systematic proactive screening for multiple health risks in health care settings as it is more resource-saving than single focused screening.

Understanding treatment-seeking smokers' motivation to change: content analysis of the decisional balance worksheet.

The Decisional Balance Worksheet (DBW), an open-ended measure of motivation to change, may be used to record the pros and cons of smoking versus abstinence among treatment-seeking smokers. Recent findings indicated that the open-ended DBW could be quantified to validly reflect people's level of motivation to stop smoking (Collins, Eck, Torchalla, Schröter, & Batra, 2010). The goal of the current study was to enhance our understanding of these participants' motivation to change by examining the qualitative content of their decisional balance. Participants were treatment-seeking smokers (N=268) who had participated in a larger randomized controlled trial of tailored smoking cessation interventions (Batra et al., 2010). Using the DBW, participants recorded their pros and cons of smoking versus abstinence, and content analysis methods were used to extract common themes. Findings indicated that the physical and psychological effects/functions of smoking and abstinence were most commonly mentioned as both pros and cons. Although the decisional balance categories were substantively similar over time, their relative frequency shifted from pre- to posttreatment. For the sample as a whole, the number of pros of smoking generally decreased, whereas the pros of abstinence increased from pre- to posttreatment. Findings suggest that clinicians can expect certain perceived pros and cons to characterize their clients' decision-making process about smoking and abstinence. At the same time, the use of the decisional balance allows for assessment of individuals' unique motivational set.

Decisional balance proportion: quantifying qualitative data to represent motivation to change among treatment-seeking smokers.

This study tested a new measure of motivation to change as a predictor of smoking behavior following smoking cessation treatment. Participants were adult, regular smokers (N=191) who took part in a randomized smoking cessation trial in southwestern Germany (Batra et al., 2010). Participants completed smoking and psychological self-report measures before and after a 6-week smoking cessation treatment. Among these measures, the open-ended decisional balance worksheet elicited participant-generated pros and cons of smoking versus abstinence. Counts of the pros and cons were combined into the decisional balance proportion (DBP), which reflected participants' current balance towards smoking behavior change. Additional smoking assessments were conducted up to the 12-month follow-up. After controlling for group effects and baseline smoking, DBP change scores (posttreatment-pretreatment) reflecting greater movement towards change during treatment predicted time to first smoking lapse as well as abstinence up to the 12-month follow-up. Higher DBP change scores also predicted lower frequency and intensity of smoking lapses during the 12-month follow-up. Findings indicated that participant-generated, qualitative data from a decisional balance worksheet can be quantified to produce a valid measure of motivation to change among smokers. This measure can inform intervention content and may potentially be used to match smokers to appropriate treatments.

A cluster-randomized effectiveness trial of smoking cessation modified for at-risk smoker subgroups.

A. Batra, S.E. Collins, I. Torchalla, M. Schröter, and G. Buchkremer (2008) showed that smokers reporting higher levels of nicotine dependence, novelty seeking/hyperactivity, and depressivity (i.e., at-risk smokers) evinced higher rates of posttreatment smoking than smokers reporting lower scores on self-report psychological symptom measures (i.e., lower risk smokers). This study aimed to replicate the smoker subgroups and test the comparative effectiveness of standard pharmacobehavioral smoking cessation versus modified smoking cessation matched to at-risk smokers' needs. On the basis of their self-report responses, adult regular smokers (N = 268) were classified into smoker subgroups. At-risk smokers were randomly assigned to receive the standard or modified treatments; lower risk smokers received standard treatment. Modified treatment produced higher abstinence rates than the standard treatment for depressive smokers but not for other at-risk smokers. Overall, abstinence rates among at-risk smokers receiving modified treatment were not significantly different from those of lower risk smokers; however, abstinence among higher dependence smokers receiving modified treatment decreased at higher rates than among lower risk smokers.

Validity of the timeline followback among treatment-seeking smokers in Germany.

Few studies have assessed the convergent validity of the timeline followback for smoking (TLFB-S) among treatment-seeking smokers, and there are no studies assessing its discriminant validity. Further, no studies to date have documented the psychometric properties of the TLFB in the German population. The aim of this study was therefore to test the convergent and discriminant validity of the TLFB-S among adult, treatment-seeking smokers in Germany. In the context of a smoking cessation trial, participants (N=268) completed sociodemographic, TLFB-S and other, self-aggregated, single-item (SA) smoking measures at pretreatment. During the 12-month posttreatment period, participants completed TLFB-S and biochemically validated SA measures of smoking intensity and abstinence at regular intervals. Discriminant validity analyses showed no significant associations for substance-use and sociodemographic variables and measurement discrepancy between TLFB-S and SA measures of pretreatment smoking intensity. Convergent validity analyses indicated that TLFB-S and SA measures of smoking intensity were in high agreement at both pretreatment and posttreatment. Finally, there was high concordance between TLFB-S and SA measures of abstinence at both 1- and 12-month posttreatment. This study replicated and extended the current literature on the TLFB and showed that, even across cultures, it can be a valid measure of various smoking-related variables.

Implementation of a smoking cessation treatment integrity protocol: treatment discriminability, potency and manual adherence.

Testing manual adherence and treatment discriminability and potency have become increasingly important to ensuring the internal validity of treatment studies [Moncher, F.J., & Prinz, R.J., (1991). Treatment fidelity in outcome studies. Clinical Psychology Review, 11, 247-266.]. The objective of this study was therefore to implement the treatment integrity protocol based on the standardized framework proposed by Waltz, Addis, Koerner and Jacobson [Waltz, J., Addis, M.E., Koerner, K., & Jacobson, N.S., (1993). Testing the integrity of a psychotherapy protocol: Assessment of adherence and competence. Journal of Consulting and Clinical Psychology, 61, 620-630.] to assess manual adherence and treatment discriminability and potency in a smoking cessation trial. Audio recordings of 15, 6-week smoking cessation groups were randomly selected from a sample of 31 groups and were rated for treatment integrity. Findings offered partial evidence for manual adherence which did not differ according to treatment condition. Analyses also indicated that the treatments were potent yet not highly discriminable across conditions. Despite some challenges, this preliminary application of the Waltz et al. [Waltz, J., Addis, M.E., Koerner, K., & Jacobson, N.S., (1993). Testing the integrity of a psychotherapy protocol: Assessment of adherence and competence. Journal of Consulting and Clinical Psychology, 61, 620-630.] protocol indicated that it is a promising and flexible tool that may be used to examine different aspects of treatment integrity.