Study protocol for clinical trial of the FIT Families multicomponent obesity intervention for African American adolescents and their caregivers: Next step from the ORBIT initiative.

INTRODUCTION: This study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control condition, Home-Based Family Support (HBFS). This protocol paper describes the design of a randomised clinical trial testing the efficacy of the FIT intervention. The protocol will assess the efficacy of FIT to improve health status in African American adolescents with obesity (AAAO) and their primary caregivers on primary (percent body fat) and secondary (physical activity, metabolic control, weight loss) outcomes and its cost-effectiveness. METHODS: 180 youth/caregiver dyads are randomised into FIT or HBFS, stratified by age, gender and baseline per cent overweight. The proposed study follows a two condition (FIT, HBFS) by four assessment time points. Tests will be conducted to identify potential relationship of baseline demographic and clinical variables to our dependent variables and see whether they are balanced between groups. It is hypothesised that youth/caregiver dyads randomised to FIT will show significantly greater reductions in percent body fat over a 12-month follow-up period compared with AAAO receiving HBFS. Preliminary findings are expected by November 2023. ETHICS: This protocol received IRB approval from the Medical University of South Carolina (Pro00106021; see 'MUSC IRB 106021 Main Approval.doxc' in online supplemental materials). DISSEMINATION: Dissemination activities will include summary documents designed for distribution to the broader medical community/family audience and submission of manuscripts, based on study results, to relevant peer-reviewed scientific high-impact journals. TRIAL REGISTRATION NUMBER: NCT04974554.

Treatment Goals and Alcohol Use Outcomes in Veterans With Comorbid Alcohol Dependence and Posttraumatic Stress Disorder.

BACKGROUND AND OBJECTIVES: Previous research demonstrates the utility of goals in attaining improved drinking outcomes. Considerably less is known about the association between substance use goals and outcomes among persons with comorbid substance use disorder (SUD) and posttraumatic stress disorder (PTSD). This secondary analysis examined the association between alcohol use outcomes and participants' treatment entry substance use goals to either abstain or reduce substance use in the context of treatment for comorbid SUD/PTSD. METHODS: Participants (N = 39) were treatment-seeking veterans with current alcohol dependence and PTSD. Participants completed self-report and clinician-rated measures of substance use and PTSD as part of a larger randomized controlled trial. RESULTS: Participants in both goal groups (abstain; reduce) achieved significant reductions in the likelihood of drinking and the likelihood of exceeding low-risk drinking levels. The primary analysis did not identify significant differences in outcome between goal groups; however, the exploratory analysis revealed that participants with reduced use goals were more likely to drink and more likely to exceed low-risk drinking levels. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: The findings suggest a moderately strong association between substance use goal and drinking outcome in the current study. Although the findings did not unequivocally support abstinence as a superior treatment goal, they offer a preliminary indication that abstinence may be an overall lower-risk option. These findings expand consideration of the utility of substance use goals and suggest that clinicians should invite consideration of abstinence but may need not limit integrated treatment for SUD/PTSD based on strict adherence to abstinence, particularly if low-risk use goals are targeted. (Am J Addict 2021;30:131-137).

Treating cannabis use disorder: Exploring a treatment as needed model with 34-month follow-up.

Research has demonstrated that motivational enhancement (MET) and cognitive behavioral therapy (CBT) are some of the most effective interventions for adults with cannabis use disorder (CUD). As few as two sessions of combined MET and CBT has produced abstinence and reductions in cannabis use greater than delayed treatment controls. Despite their efficacy, outcomes in previous studies yielded abstinence rates from cannabis in the range of 20-30% at follow-ups of 6 to 12 months, and CUD remained a chronic condition for many. Additional models of providing treatment "as needed" (PRN), rather than as a single fixed-dose, are necessary to meet the different needs of adults with CUD and reengage those who do not respond to treatment initially or who relapse later. In the current study, 87 adults who met DSM-IV criteria for cannabis dependence were randomly assigned to receive either a fixed-dose of nine sessions of MET/CBT or to a PRN condition that provided a smaller initial dose of treatment, but allowed repeated access to treatment for 28 months. Cannabis use and associated problems were assessed every six months throughout a 34-month period. More than one-third of participants in the PRN condition accessed additional treatment episodes, but the total number of treatment sessions that participants utilized was comparable across conditions. Both treatments yielded significant reductions in cannabis use and associated problems at each follow-up. Contrary to hypotheses, the PRN condition did not yield better outcomes at the longer-term follow-ups. The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes. Future studies should test active approaches to reengaging participants with treatment when initial outcomes are less than optimal.

Emotional Processing of Imaginal Exposures Predicts Symptom Improvement: Therapist Ratings Can Assess Trajectory in Prolonged Exposure for Posttraumatic Stress Disorder.

Research on mechanisms of change in prolonged exposure therapy (PE), an evidence-based treatment for posttraumatic stress disorder (PTSD), is ongoing. Two putative mechanisms of change are engagement during imaginal exposure and trauma-related belief change. The PE Therapist Questionnaire (PETQ), a novel measure based on the emotional processing theory underlying PE, was developed as a practical tool for therapists to use to assess (a) patient engagement during imaginal exposures and (b) perspective shifts during postimaginal processing. Patients (N = 151) at a U.S. Veterans Affairs medical center PTSD specialty clinic completed self-report measures of PTSD and depression symptoms prior to sessions. Study therapists (n = 17) completed the PETQ postsession. Rational construction and psychometric analyses suggested a two-component solution for the PETQ: imaginal and processing. The imaginal factor did not relate to PTSD and depression symptoms. The processing factor correlated with current and next-session PTSD and depression symptoms, with medium effect sizes, rs = -.41 to -.45, ps < .001. Controlling for current-session PTSD and depression, a higher level of processing predicted lower next-session PTSD severity, with a small effect size, ß = -.38, p < .04. Postexposure emotional processing, which supports positive changes in maladaptive trauma-related beliefs and tolerance of emotional distress, predicted future symptom improvement, highlighting the importance of processing components in PE. Further, the use of therapist observations may offer ancillary methods less influenced by correlation of within-patient subjective ratings and concomitant risk of construct overlap in mechanisms research.

An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

BACKGROUND: Posttraumatic stress disorder (PTSD) rarely remits over time, and if left untreated, leads to significant distress, functional impairment, and increased health care costs. Fortunately, effective evidence-based treatments (EBTs) for PTSD, such as Prolonged Exposure (PE), exist. Despite their availability and efficacy, a significant number of individuals with PTSD do not initiate treatment when offered or dropout prematurely. One proposed theory suggests that the emotional-numbing symptoms of PTSD (e.g., blunted affect, apathy) can serve as a barrier to engaging in, and successfully completing, treatment; and the broad human-animal interaction (HAI) literature available suggests that HAI can potentially reduce emotional numbing related to PTSD. Accordingly, this manuscript describes an ongoing, federally funded, randomized controlled trial testing the efficacy of RESCUE, an HAI intervention, as a viable adjunctive treatment component for PE. METHODS/DESIGN: The study will include 70 veterans with PTSD treated at a Southeastern Veterans Affairs Medical Center (VAMC). All participants in the trial receive up to 12 sessions of PE. Participants are randomly assigned 1:1 to (1) volunteer at a local animal shelter or (2) volunteer at a community agency of their choice as part of their in-vivo exposure exercises for PE. Outcomes will be examined via standard clinical interviews, self-report questionnaires, and thematic interviews. DISCUSSION: It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition. If successful, RESCUE, could be easily incorporated into standard PE and broadly disseminated. TRIAL REGISTRATION: ClinicalTrials.gov. ID: NCT03504722. Retrospectively registered on 2 May 2017.

Protocol for the evaluation of a digital storytelling approach to address stigma and improve readiness to seek services among veterans.

BACKGROUND: Research suggests that at least 10% of veterans returning from Iraq and Afghanistan meet criteria for posttraumatic stress disorder (PTSD) related to their military experiences. National dissemination initiatives have increased veterans' access to best-practice interventions. However, treatment-seeking remains low among veterans with PTSD, often due to perceived stigma and other associated barriers. The National Center for PTSD recently developed and launched AboutFace, a digital storytelling (DST) resource designed to help veterans recognize PTSD and motivate them to seek evidence-based treatment. The Ralph H. Johnson Veterans Affairs Medical Center (VAMC) and the National Center for PTSD have partnered to conduct pilot work to evaluate veterans' reactions to AboutFace to set the stage for a large-scale study to examine whether AboutFace effectively reduces stigma and improves attitudes toward treatment-seeking among veterans. If effective, this DST approach may serve as a valuable national model for a variety of treatment-seeking populations. METHODS: During the first phase of the pilot, in-person usability assessments of AboutFace will be conducted via semi-structured interviews with 20 veterans. Audio recordings of interviews will undergo transcription and coding. A report of the results of qualitative analyses of these interviews will be provided to the National Center for PTSD and will inform revisions to the site. In the second phase of the pilot, 60 veterans referred to a specialized PTSD clinic will be recruited to demonstrate and refine the methodology that we propose to use in a larger randomized controlled trial evaluation of AboutFace. Veterans will be randomly assigned to receive AboutFace plus standard education vs. standard education alone. Baseline and 2-week telephone assessments will be conducted with participating veterans to measure stigma, attitudes toward seeking mental health services, and treatment access/engagement. DISCUSSION: The feedback we receive in this pilot will be used to strengthen the quality of the DST website in preparation for a large-scale evaluation. Future work will involve evaluation of reach and impact of the site relative to stigma, attitudes toward seeking mental health service, and utilization of care. If AboutFace is found to increase access to care, this finding would have broad and significant implications for overcoming barriers to care for veterans and other populations with stigmatized conditions. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02486692.

To reduce or abstain? Substance use goals in the treatment of veterans with substance use disorders and comorbid PTSD.

BACKGROUND: Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) frequently co-occur. Previous research demonstrates the utility of goals in attaining improved SUD outcomes, however, no previous studies have examined goal choices in the context of integrated treatment for comorbid PTSD and SUD. OBJECTIVES: The present study investigated correlates of treatment entry goals to either reduce or abstain from substance use. METHODS: Participants (N = 60) were treatment-seeking veterans with current PTSD and SUD. Participants completed self-report and clinician-rated measures of substance use, PTSD, and affective symptoms as part of a larger randomized controlled trial. RESULTS: Half (30/60) of participants endorsed a treatment entry goal to reduce substance use (reducers). Compared to participants who endorsed a treatment entry goal of abstinence (abstainers), reducers were significantly younger, more likely to be employed, more likely to have served in recent military conflicts (Operations Enduring/Iraqi Freedom), and endorsed significantly fewer symptoms of alcohol dependence. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: The findings demonstrate clinically relevant differences based on treatment entry goals, suggesting that individuals are often able to choose conceivably appropriate treatment goals based, most notably, on the severity of their SUD. Collaboratively engaging patients in establishing treatment goals that are consistent with their beliefs and desires in conjunction with empirical findings is particularly relevant in the context of treatment for SUD and PTSD where many patients are ambivalent about treatment and attrition is common.

Brief motivational feedback may enhance treatment entry in veterans with comorbid substance use and psychiatric disorders.

BACKGROUND AND OBJECTIVES: There are limited investigations of brief interventions to facilitate treatment entry among individuals with substance use disorders. This study investigated the effectiveness of brief motivational feedback (BMF) for increasing entry into intensive substance abuse treatment in veteran patients. METHODS: Veteran patients (N = 84) with substance use disorders referred for an intake assessment in a substance abuse specialty clinic received either (i) intake assessment plus BMF or (ii) intake assessment as usual (AAU). BMF consisted of brief motivational enhancement feedback pertaining to estimates of alcohol and drug consumption, money spent on drugs and alcohol, and self-reported problems due to substance abuse. Primary outcome was entry in treatment groups in an intensive outpatient program for substance abuse. RESULTS: Patients in BMF and AAU conditions did not significantly differ on indices of treatment entry. However, among patients with comorbid substance dependence and psychiatric disorders, those who received BMF were significantly more likely to enter outpatient treatment groups. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: The addition of motivational feedback to a standard intake assessment enhanced substance abuse treatment entry among veteran patients with comorbid substance use disorders and psychiatric disorders. These preliminary findings extend the use of motivational feedback to facilitate entry into substance abuse treatment among veteran patients with comorbid substance use and psychiatric disorders. Furthermore, they suggest opportunity for more effective patient-treatment matching based on initial motivation and other individual factors such as psychiatric comorbidity.

Exposure therapy for PTSD delivered to veterans via telehealth: predictors of treatment completion and outcome and comparison to treatment delivered in person.

Recent research has focused on the effectiveness of evidence-based psychotherapy delivered via telehealth services. Unfortunately to date, the majority of studies employ very small samples and limited predictor and moderator variables. To address these concerns and further replicate and extend the literature on telehealth, the present study investigated the effectiveness of 12-session exposure therapy delivered either via telehealth (n=62) or in person (n=27) in veterans with posttraumatic stress disorder (PTSD). Findings demonstrated that although older veterans and Vietnam veterans were more likely to complete the telehealth treatment, telehealth findings were not influenced by patient age, sex, race, combat theater, or disability status. Exposure therapy delivered via telehealth was effective in reducing the symptoms of PTSD, anxiety, depression, stress, and general impairment with large effect sizes. Interestingly, exposure therapy via telehealth was less effective than exposure therapy delivered in person; however, lack of random assignment to condition limits conclusions of differential effectiveness. Overall, these findings support the utility of telehealth services to provide effective, evidence-based psychotherapies.

Comparison of participatively set and assigned goals in the reduction of alcohol use.

The effects of setting goals on goal commitment, self-efficacy for goal achievement, and goal achievement in the context of an alcohol use intervention were examined using an experimental design in which participants were randomized to participatively set goals, assigned goals, and no goal conditions. One hundred and twenty-six heavy-drinking college students received a single cognitive-behavioral assessment/intervention session and completed measures of goal commitment, self-efficacy for goal achievement, and alcohol use. Results were consistent with, and expanded upon, previous research by demonstrating that having a goal for limiting alcohol consumption was predictive of lower quantity and frequency of alcohol use relative to not having a goal. Participation in goal setting yielded greater goal commitment and self-efficacy for goal achievement than assigned goals, but did not result in significantly greater reductions in alcohol use relative to assigned goals. Goal commitment and self-efficacy explained unique variance in the prediction of alcohol use at follow-up. Findings support the importance of goal setting in alcohol interventions and suggest areas for further research.

Contracting, prompting, and reinforcing substance use disorder continuing care: a randomized clinical trial.

Although continuing care is strongly related to positive treatment outcomes for substance use disorder (SUD), participation rates are low and few effective interventions are available. In a randomized clinical trial with 150 participants (97% men), 75 graduates of a residential Veterans Affairs Medical Center SUD program who received an aftercare contract, attendance prompts, and reinforcers (CPR) were compared to 75 graduates who received standard treatment (STX). Among CPR participants, 55% completed at least 3 months of aftercare, compared to 36% in STX. Similarly, CPR participants remained in treatment longer than those in STX (5.5 vs. 4.4 months). Additionally, CPR participants were more likely to be abstinent compared to STX (57% vs. 37%) after 1 year. The CPR intervention offers a practical means to improve adherence among individuals in SUD treatment.

Abstinence and moderate use goals in the treatment of marijuana dependence.

AIMS: The purpose of this study was to examine the influence of personal goals (abstinence or moderation) on treatment outcomes for marijuana use. Hypotheses regarding self-efficacy for goal attainment were tested. DESIGN: Adult marijuana users seeking treatment were assigned randomly to three treatment conditions: (1) cognitive-behavioral relapse prevention support group; (2) individualized brief motivational enhancement; and (3) delayed treatment control group. Follow-up assessments were conducted at 4, 7, 13 and 16 months. SETTING: University research offices. PARTICIPANTS: Participants were 291 adult marijuana users. Measurements Marijuana use, personal treatment goals and self-efficacy for achieving one's goal were assessed across the 16-month follow-up. FINDINGS: Greater marijuana related problems and dependence symptoms were associated with an initial goal of abstinence. Participants were more likely to achieve outcomes consistent with their personal goals. Participants with abstinence goals reported greater self-efficacy for goal achievement than those with moderation goals after participating in the abstinence oriented treatment; self-efficacy for goal success predicted goal achievement for both moderate use and abstinence goals. CONCLUSIONS: Marijuana users approaching an abstinence-oriented treatment varied in the extent to which they were actively seeking abstinence as the outcome. Differences in goals were predictable from severity of problems related to use. Goal preference and self-efficacy for achieving goals predicted outcomes. Future research should incorporate personal goals into treatment and assess their effects on outcomes.