Interventions to Improve Post-Detoxification Treatment Engagement and Alcohol Recovery: Systematic Review of Intervention Types and Effectiveness.

AIMS: Most inpatient alcohol detoxification patients do not seek treatment post-discharge, which increases the risk of relapse and re-hospitalization. To date, there have been no efforts to synthesize the evidence supporting the broad range of available interventions for this critical transition. The current study is a systematic review and evaluation of interventions designed to promote treatment engagement and recovery following alcohol detoxification. METHODS: The initial literature search yielded 6419 articles, published since 1999, from PubMed, CINAHL, PsycINFO, Psychology & Behavioral Sciences Collection and PsycARTICLES databases, 49 of which were eligible for full review. Data extraction included in-depth evaluation of intervention types, study and research design features, reported outcomes and study quality/bias indicators. All articles were coded by independent raters and final results were obtained through consensus. RESULTS: Interventions included medical/medication, psychological/psychosocial, technological, mutual-help and combined approaches. On average, medical/medication interventions were less, and psychological/psychosocial and technological interventions were more likely to demonstrate efficacy with respect to treatment engagement and recovery. There was significant variability in study quality/bias but no significant differences across intervention types. Studies differed considerably across measured outcomes, internal and external validity, in/exclusion criteria and documentation of co-occurring psychiatric disorders. CONCLUSION: Over half of studies reviewed reported empirical support for the intervention(s) evaluated. Although findings slightly favor non-medical interventions, the variability in study design and quality/bias requires more rigorous follow-up research. Recommendations from this review may guide future implementation and intervention development, which are critically needed to improve post-detoxification care and outcomes for patients with alcohol use disorder.

Buprenorphine Naloxone and Extended Release Injectable Naltrexone for the Treatment of Opioid Use Disorder Among a Veteran Patient Sample: A Retrospective Chart Review.

OBJECTIVE: Previous research has demonstrated the effectiveness of both extended-release injectable naltrexone (XR-NTX) and buprenorphine/naloxone (BUP-NX) in the treatment of opioid use disorder (OUD). However, studies using real-world samples with multiple medical and psychiatric comorbidities are lacking. The study's primary aims were to: (1) compare clinical presentations in an inclusive sample of OUD-diagnosed US military veterans receiving XR-NTX and BUP-NX, and (2) investigate differences in 90-day treatment outcomes between these two groups. Methods: The medical records of 79 patients receiving medications to treat OUD in a VA hospital's addiction outpatient treatment program were reviewed retrospectively. The analysis included all veterans who initiated medication treatment during the study period. Differences between medication groups on co-occurring diagnoses, treatment retention, and related outcomes were examined. Results: The two groups were similar in medical and psychiatric comorbidity, although the BUP-NX group were more likely to have a pain diagnosis. No statistically significant differences in retention or toxicology results were found between the two groups over the 90-day study period. The rate of positive urine screens for the BUP-NX group was 19.2% for opiates and 13.5% for other illicit substances, and 3.7% and 11.1% respectively for the XR- NTX group. Conclusion: There was no evidence that 90-days outcomes differed for veterans based on medication received, and there were more similarities than differences in clinical characteristics. Additional research is needed, including larger sample size and prospective randomized control trial to evaluate VA patients' treatment outcomes receiving BUP-NX or XR-NTX for OUD.

Sexual minority college students' perceptions on dating violence and sexual assault.

While the majority of research on dating violence (DV) and sexual assault (SA) in college students has focused on heterosexual students, victimization rates among sexual minority students are the same or higher than that of their heterosexual counterparts. The current study sought to explore sexual minority college students' perceptions of the prevalence of DV and SA, risk and protective factors, and barriers to seeking help, using focus groups. A total of 14 sexual minority students ranging in age from 18 to 24 participated across 2 focus groups. Findings suggest the majority of the students perceived DV and SA among sexual minority individuals to be less common compared to their heterosexual counterparts and to be less common on their campus compared to other colleges and universities. Students' reflections about risk and protective factors overlapped with those previously established among heterosexuals as well as factors unique to the sexual minority community. Students identified societal, community, and psychological-level barriers related to help-seeking. We provide recommendations for practice based on the current findings (e.g., colleges could expand current educational material about DV and SA to include more recognition of these issues for sexual minority students). (PsycINFO Database Record

Factors that distinguish college students with depressive symptoms with and without suicidal thoughts.

BACKGROUND: Suicide among college students is a significant public health concern. Although suicidality is linked to depression, not all depressed college students experience suicidal ideation (SI). The primary aim of this study was to determine potential factors that may distinguish college students with depressive symptoms with and without SI. METHODS: A total of 287 undergraduate college students with substantial depressive symptoms (Beck Depression Inventory [BDI] total score >13) with and without SI were compared across psychiatric and functional outcome variables. Independent sample t tests were conducted for each outcome variable using the suicide item of the BDI as a dichotomous (ie, zero vs nonzero score) grouping variable. RESULTS: Relative to students with substantial depressive symptoms without SI, those with SI were more symptomatic overall, having significantly higher levels of depressive symptoms, hopelessness, and anxiety. However, contrary to our expectations, nonsuicidal and suicidal students did not differ on measures of everyday functioning (ie, cognitive and physical functioning and grade point average). CONCLUSIONS: Our findings suggest that SI among college students is associated with increased subjective distress but may not adversely impact physical or cognitive functioning or academic performance.

Does the frequency of follow-up assessments affect clinical trial outcome? A meta-analysis and meta-regression of placebo-controlled randomized trials.

The number and temporal distribution of follow-up assessments during a clinical trial is a critical factor which may influence the outcome as well as the overall cost of a trial. Therefore, we aimed to examine whether the overall and differential frequency of study observations during the course of a clinical trial affects the risk ratio (RR) of responding to antidepressants vs. placebo, specifically in trials for major depressive disorder (MDD). Medline/Pubmed publication databases were searched for randomized, double-blind, placebo-controlled trials of antidepressants for adults with MDD (1 January 1980-11 May 2010). A total of 142 manuscripts involving 256 drug-placebo comparison were pooled (n=38 860). We found that higher overall frequency (OF, frequency of assessments during the entire trial) and higher late frequency (LF, frequency of assessments after the first 3 wk of the trial), but not higher early frequency (EF, frequency of assessments during the first 3 wk of the trial), of follow-up visits predicted a significantly greater RR of responding to antidepressant vs. placebo (coefficient=0.213, p=0.014; coefficient=0.238, p=0.003; and coefficient=0.021, p=0.755, respectively, for OF, LF and EF). None of the measures of frequency examined (OF, EF, LF) significantly predicted the RR of discontinuing antidepressant vs. placebo. These findings suggest that increasing the number of follow-up visits, specifically after the third week rather than within the first 3 wk of the trial, may be an effective approach to improve the likelihood of success in placebo-controlled clinical trials for MDD.

A Randomized Pilot Study of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD.

Veterans with PTSD often have substantial interpersonal difficulties and low levels of social support, which puts them at increased risk of mortality, but few treatments address global social impairment for veterans with PTSD. This study is a pilot randomized trial of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a psychotherapy that targets social avoidance and eroded social relationships, compared to Person-Centered Therapy (PCT), a non-directive psychotherapy. Participants were randomized to twelve sessions of either ACT-SS (n = 21) or PCT (n = 19). The results showed that veterans with PTSD had high ratings of satisfaction for both treatments. Contrary to the PCT group, participants in the ACT-SS group showed a significant improvement in the quality of social relationships, engagement in social and leisure activities, and PTSD symptoms from the baseline assessment to the end of treatment and a three-month follow-up. Veterans in the ACT-SS group, but not the PCT group, also showed significant improvements in mindfulness and valued living and a reduction in experiential avoidance from baseline to the end of treatment, with sustained improvements in valued living at the three-month follow-up. Overall, the present study demonstrated the feasibility, acceptability, and positive preliminary outcomes of ACT-SS for veterans with PTSD.

Innovating for real-world care: A systematic review of interventions to improve post-detoxification outcomes for opioid use disorder.

BACKGROUND: Inpatient detoxification is a common health care entry point for people with Opioid Use Disorder (OUD). However, many patients return to opioid use after discharge and also do not access OUD treatment. This systematic review reports on the features and findings of research on interventions developed specifically to improve substance use outcomes and treatment linkage after inpatient detoxification for OUD. METHODS: Of 6419 articles, 64 met inclusion criteria for the current review. Articles were coded on key domains including sample characteristics, study methods and outcome measures, bias indicators, intervention type, and findings. RESULTS: Many studies did not report sample characteristics, including demographics and co-occurring psychiatric and substance use disorders, which may impact postdetoxification OUD treatment outcomes and the generalizability of interventions. Slightly more than half of studies examined interventions that were primarily medical in nature, though only a third focused on initiating medication treatment beyond detoxification. Medical and combination interventions that focused on initiating medications for OUD generally performed well, as did psychological interventions with one or more reinforcement-based components. CONCLUSIONS: Research efforts to improve post-detoxification outcomes would benefit from clearer reporting of sample characteristics that are associated with treatment and recovery outcomes, including diagnostic comorbidities. Findings also support the need to identify ways to introduce medication for opioid use disorder (MOUD) and other effective treatments including reinforcement-based interventions during detoxification or soon after.

Envisioning a future: Values clarification in early recovery from opioid use disorder.

High rates of relapse and overdose during early recovery from opioid use disorder (OUD) highlight the importance of providing effective treatment during this crucial phase. While early treatment often focuses on managing urges and withdrawal symptoms, eliciting personally salient motivators may help to target predictors of treatment outcomes such as motivation and self-efficacy. This experimental study examined the effect of a brief values clarification exercise on motivation and self-efficacy for abstinence in a sample of n = 93 individuals in brief residential treatment for OUD. Participants were randomly assigned to values clarification or a time management control condition exercise. Self-efficacy for abstinence as measured by a validated single-item measure was higher for participants in the values condition (M = 8.7) compared to control (M = 7.8, p = .013), while motivation for abstinence as measured by the commitment to sobriety scale was similarly high for both the values clarification (M = 28.0) and control (M = 27.8, p = .642) groups. There were no group differences in delay discounting, the theorized mediator of these relationships. Taken together, these results suggest that even a brief values clarification exercise may increase self-efficacy for abstinence when added to early residential treatment for OUD.

Unprecedented need and recommendations for harnessing data to guide future policy and practice for opioid use disorder treatment following COVID-19.

The COVID-19 pandemic struck in the midst of an ongoing opioid epidemic. To offset disruption to life-saving treatment for opioid use disorder (OUD), several federal agencies granted exemptions to existing federal regulations. This included loosening restrictions on medications for OUD (MOUD), including methadone and buprenorphine. In this commentary, we briefly review policy and practice guidelines for treating OUD prior to the onset of the COVID-19 pandemic. We then outline specific MOUD treatment policy and practice exemptions that went into effect in February and March 2020, and discuss the ways in which these unprecedented changes have dramatically changed MOUD treatment. Given the unprecedented nature of these changes, and unknown outcomes to date, we advocate for a data-driven approach to guide future policy and practice recommendations regarding MOUD. We outline several critical clinical, research, and policy questions that can inform MOUD treatment in a post-COVID-19 era.

Public implementation of a web-based program for veterans with risky alcohol use and PTSD: A RE-AIM evaluation of VetChange.

BACKGROUND: Evidence-based web and mobile interventions are available for a range of mental health concerns. Little is known about how self-administered web interventions are used outside of controlled research trials, and there is a critical need to empirically examine real-world public implementation of such programs. To this end, the aim of the current study was to evaluate and describe outcomes of a nationwide public implementation of VetChange, a self-administered web intervention for veterans with problematic alcohol use and symptoms of PTSD. METHOD: The study used the RE-AIM framework to organize outcomes along five key dimensions: reach, effectiveness, adoption, implementation, and maintenance. This naturalistic observation study included program use information for all who registered an account with VetChange during the 2-year study period and who self-identified as a returning veteran. We collected program use data automatically via normal website operation; a subset of program users provided additional self-report outcome data. The study used linear multilevel mixed modeling to evaluate changes in alcohol use and PTSD symptoms over a six-month postregistration period. RESULTS: VetChange successfully reached a large, geographically diverse sample of returning veterans with risky drinking and PTSD symptoms. Despite variable, overall modest, rates of intervention use over time, registered users demonstrated significant improvements in drinking, PTSD, and quality of life, and participants maintained these outcomes at a six-month follow-up. CONCLUSIONS: Given the observed low cost per acquisition, positive clinical outcomes, and the potential to produce long-term cost savings through reduced health care burden associated with chronic alcohol use disorder and PTSD, this study demonstrates how web-based interventions can provide public health benefits and reduce long-term health care costs.

Differential alcohol treatment response by gender following use of VetChange.

OBJECTIVE: Proportionally more women use online alcohol interventions but also report less robust treatment outcomes compared to men. Less is known about outcome disparities among veteran women, who are a growing demographic nationally. The current study examined gender differences among returning veteran men and women who used VetChange, a web-based intervention for hazardous drinking and posttraumatic stress symptoms (PTSS). METHOD: Using data from a nationwide implementation study of returning combat veterans (n = 222), we performed hierarchical linear modeling to examine gender differences in alcohol and PTSS outcomes over six months following VetChange registration. Additional analyses examined gender differences in proportional changes in hazardous drinking and at each assessment point. RESULTS: Returning veterans reported significant decreases in alcohol use and PTSS over time, yet men evidenced significantly greater reduction in average weekly drinks and drinks per drinking day compared to women. Follow up analyses indicated that women were significantly less likely than men to achieve low-risk drinking by one month post-registration. Proportional change in alcohol use yielded marginal and non-significant trends that were, nonetheless, consistent with the overall pattern of gender differences. CONCLUSION: These results contribute to emerging literature suggesting that women use online alcohol use interventions at proportionately higher rates than do men, but do not reduce their drinking as much as men. There are a number of potential content changes that could improve outcomes for returning veteran women using online interventions, and data-driven adaptations based on stakeholder input are recommended.

An Analysis of Help-Seeking Patterns Among College Student Victims of Sexual Assault, Dating Violence, and Stalking.

Despite the negative outcomes associated with sexual assault (SA), dating violence (DV), and stalking victimization, many victims, particularly college students, do not seek help for these crimes. To date, the majority of help-seeking research has focused on one form of victimization, despite substantial evidence that many victims experience more than one form of interpersonal violence. In addition to consideration of such polyvictims, intervention efforts to increase help-seeking to improve victim outcomes may benefit from a clearer understanding of overlapping predictors of help-seeking across victimization types. Using the health belief model (HBM) as a guiding framework, the current study examined predictors of help-seeking for SA, DV, and stalking in a college student sample. Data were collected via a multiyear anonymous email survey of general health and well-being. Demographic predictors of help-seeking and severity indicators informed by the HBM were evaluated across violence types. In addition to replicating previous work, results provided support for the HBM, such that a number of severity indicators, particularly those representing overlap across victimization types, predicted help-seeking at the multivariate level. Results also provide new evidence for overlap of barriers to help-seeking across violence types, with victim's belief that the incident was not serious enough the most commonly reported reason for not seeking help across all three types of victimization. This overlap may provide opportunities for consolidating prevention and intervention efforts across victimization types.

A Naturalistic Evaluation of a Group Intervention for Parents of Youth with Substance Use Disorders.

Parents of youth with substance use disorders (SUDs) often play a vital role in successful treatment, yet little is known about interventions designed to help them cope with the stress of this role, especially as delivered in real-world settings. Evaluations of such interventions could potentially inform adaptations to enhance their clinical utility. Parents of youth with SUDs attending a clinician-led group based on the CRAFT model completed measures at intake, 4- and 8-weeks. Parents (n=545) attended an average of 3.7 sessions; 12% completed all 8 weeks. Analysis of demographic predictors of retention indicated that older parents attended more sessions on average. Overall stress did not change across time points (p>0.05). However, parents reported improvement in parent empowerment as measured by the Parent Empowerment Scale, a novel measure of parent empowerment in coping with their child's SUD (p<0.001). Clinician led evidence-informed group services may improve parents' perceived ability to help their child with their SUD. Low retention rates highlight the need to better understand the factors contributing to retention, and the potential value of adaptations to shorten the intervention. Programs serving youth with SUDs may wish to consider integrating such group services to support parents.

Changes in alcohol use, PTSD hyperarousal symptoms, and intervention dropout following veterans' use of VetChange.

OBJECTIVE: Veterans of Iraq and Afghanistan conflicts report high rates of drinking, PTSD, and low rates of treatment engagement. Web interventions may help address unmet treatment need; unfortunately, little is known regarding outcomes or adherence to these interventions. In this study, we examined VetChange treatment outcomes and downstream effects of alcohol reduction on PTSD symptoms and intervention dropout rates over six months. METHOD: Participants included 222 veterans (77.5% men, 78.3% White) between 22 and 57 (mean age = 36.02, SD = 7.19). All VetChange users completed a brief alcohol assessment and received personal feedback, then received full access to intervention content including psychoeducation; motivational and cognitive-behavioral modules for relapse prevention, goal-setting, social support, stress, anger, and sleep management; and mood and drink tracking. Veterans completed self-report measures of alcohol use and PTSD symptoms at baseline, one, three, and six months. RESULTS: Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month. Greater alcohol reduction in the first month predicted higher subsequent PTSD hyperarousal severity. Over half (52.3%) dropped out by month one, followed by 12.2% and 37.6% by months three and six. Hyperarousal symptoms, hypervigilance specifically, but not alcohol use predicted subsequent intervention dropout. CONCLUSION: These results highlight the importance of attending to the association between alcohol use and PTSD symptom change in web-based interventions for veterans. The fact that hyperarousal symptoms were associated with elevated risk for intervention dropout signifies the need for online intervention refinement aimed at tailoring content to time-varying symptom presentations.

Event-related potentials index segmentation of nonsense sounds.

To understand the world around us, continuous streams of information including speech must be segmented into units that can be mapped onto stored representations. Recent evidence has shown that event-related potentials (ERPs) can index the online segmentation of sound streams. In the current study, listeners were trained to recognize sequences of three nonsense sounds that could not easily be rehearsed. Beginning 40 ms after onset, sequence-initial sounds elicited a larger amplitude negativity after compared to before training. This difference was not evident for medial or final sounds in the sequences. Across studies, ERP segmentation effects are remarkably similar regardless of the available segmentation cues and nature of the continuous streams. These results indicate the preferential processing of sequence-initial information is not domain specific and instead implicate a more general cognitive mechanism such as temporally selective attention.

A Contextual Behavior Science Framework for Understanding How Behavioral Flexibility Relates to Anxiety.

There is a growing literature focusing on the emerging idea that behavioral flexibility, rather than particular emotion regulation strategies per se, provides greater promise in predicting and influencing anxiety-related psychopathology. Yet this line of research and theoretical analysis appear to be plagued by its own challenges. For example, middle-level constructs, such as behavioral flexibility, are difficult to define, difficult to measure, and difficult to interpret in relation to clinical interventions. A key point that some researchers have made is that previous studies examining flexible use of emotion regulation strategies (or, more broadly, coping) have failed due to a lack of focus on context. That is, examining strategies in isolation of the context in which they are used provides limited information on the suitability, rigid adherence, or effectiveness of a given strategy in that situation. Several of these researchers have proposed the development of new models to define and measure various types of behavioral flexibility. We would like to suggest that an explanation of the phenomenon already exists and that we can go back to our behavioral roots to understand this phenomenon rather than focusing on defining and capturing a new process. Indeed, thorough contextual behavioral analyses already yield a useful account of what has been observed. We will articulate a model explaining behavioral flexibility using a functional, contextual framework, with anxiety-related disorders as an example.

The Impact of Experiential Avoidance and Event Centrality in Trauma-Related Rumination and Posttraumatic Stress.

Cognitive control strategies like rumination often increase posttraumatic stress disorder (PTSD) symptoms. However, extant research has provided equivocal results when attempting to explain why this phenomenon occurs. The current study explored several mechanisms that may clarify such findings. For this study, 193 trauma-exposed community members completed measures of PTSD, rumination, experiential avoidance, and event centrality. Elevated reports of rumination were associated with greater PTSD symptomology, experiential avoidance, and event centrality. Results suggest that rumination indirectly influenced PTSD symptom severity through experiential avoidance. This pattern held true regardless of whether a trauma survivor viewed their reported trauma as central or peripheral to their personal identity. These data suggest that the link between ruminating about a traumatic experience and enhanced PTSD symptomology may be partially explained by increasingly restrictive cognitive patterns and enhanced avoidance of aversive internal stimuli. Furthermore, they provide preliminary evidence to suggest that rumination and experiential avoidance are strongly associated with one another (and subsequent PTSD symptomology) among trauma survivors, regardless of how central a traumatic event is to an individual's personal narrative. Such findings support clinical interventions like exposure, which progressively support new learning in response to feared or unwanted experiences in service of expanding an individual's cognitive and behavioral repertoires.

A pilot study of acupuncture monotherapy in patients with major depressive disorder.

BACKGROUND: We have previously shown that a standardized acupuncture augmentation was effective for antidepressant partial responders with major depressive disorder (MDD). This pilot study examines the efficacy and safety of this protocol as monotherapy for MDD. METHODS: Thirty outpatients (73% female, mean age 47±12 yrs) with SCID-diagnosed MDD were recruited and received 8 weeks of standardized 30-minute open acupuncture treatment using 5 specific body points on the arms and legs bilaterally, with manual stimulation every 10 min, and concurrent electroacupuncture (2Hz current) at two points along the midline of the head. Subjects were assigned to once-weekly (n=21) or twice-weekly (n=9) treatment, depending on preference. Change in Hamilton-D-17 score was the primary outcome measure, and positive response to treatment (defined as ≥50% improvement in HAM-D-17 scores compared to baseline) was the secondary outcome measure. RESULTS: HAM-D-17 scores decreased from 19.1±4.4 to 9.9±6.3 (p<0.001) in the once-weekly acupuncture group, and from 21.9±5.3 to 14.3±6.1 (p=0.012) in the twice-weekly acupuncture group. Improvement did not differ significantly between treatment arms. Response rates were 62% for the once-weekly acupuncture group and 22% for the twice-weekly acupuncture group (NS). Twenty patients (14 in weekly treatment group and 6 in twice-weekly treatment group) completed the study. The most common side effects included mild soreness/pain (n=13), and mild bleeding (n=16) at the needle site. LIMITATIONS: Open design and small sample. CONCLUSIONS: Standardized acupuncture treatment was safe, well-tolerated and effective, suggesting good feasibility in outpatient settings. Replication in controlled trials is warranted.

Antidepressants for major depressive disorder in patients with a co-morbid axis-III disorder: a meta-analysis of patient characteristics and placebo response rates in randomized controlled trials.

The objective of this study is to assess whether the antidepressants are effective in treating major depressive disorder (MDD) in patients with a co-morbid axis-III disorder, and to compare the relative efficacy (vs. placebo) of antidepressants between these patients and those enrolled in general MDD trials. Medline/Pubmed publication databases were searched. We selected for randomized, double-blind, placebo-controlled trials of antidepressants for MDD, whether conducted in a general population, or in populations with an axis-III disorder. Antidepressants were more effective than placebo in patients with axis-III disorders overall [risk ratio for response (RR)=1.42, P<0.0001], as well as specifically for post-stroke (RR=1.43, P=0.04), human-immunodeficiency virus positive or acquired immunodeficiency syndrome (RR=1.66, P=0.005), but not cancer patients (RR=1.26, P=0.19). There was a trend for higher placebo response rates in studies, which did (41.2%) versus those which did not (37.7%) select for axis-III disorders (P=0.06), and significantly higher antidepressant response rates in studies which did (57.4%) versus those which did not (53.5%) select for axis-III disorders (P=0.01). Antidepressants are effective for MDD in patients who present with co-morbid axis-III disorders and as effective (vs. placebo) in this population as they are in the general MDD population. Higher general response rates observed in the co-morbid MDD population are intriguing, and require replication.

A pilot study of acupuncture augmentation therapy in antidepressant partial and non-responders with major depressive disorder.

BACKGROUND: Acupuncture is widely used for treating major depressive disorder (MDD). There is evidence supporting acupuncture as an antidepressant monotherapy, but its efficacy as augmentation in antidepressant partial and non-responders has not been well-investigated. METHODS: Thirty subjects (47% female, mean age 48±11 years) with a history of SCID-diagnosed MDD and partial or non-response after ≥8 weeks of antidepressant therapy were assigned 8 weeks of standardized 30-min open acupuncture augmentation sessions on a weekly (n=24) or twice-weekly (n=6) basis. Change in the Hamilton-D-17 score was the primary outcome measure, and response rates (based on HAM-D-17 score improvement of ≥50%) the secondary outcome. RESULTS: Twenty subjects (40% female; 18 in weekly and 2 in twice-weekly treatment) completed the study. In the intent-to-treat (ITT) sample (N=30), HAM-D-17 scores decreased from 18.5±3.8 to 11.2±5.3 in the weekly group (p<0.001), and from 18.5±3.3 to 11.8±4.8 in the twice-weekly group (p=0.03). Improvement did not differ significantly between treatment arms (p=0.76). Response rates were 47% for all ITT subjects, 50% for the weekly group and 33% for the twice-weekly group (p=0.66). The most common side effects included soreness/pain (n=7), bruising (n=4), and mild bleeding (n=1) at the needle site. One subject discontinued because of side effects (pain). LIMITATIONS: Open design, small sample, polypharmacy with antidepressants. CONCLUSIONS: Once or twice-weekly acupuncture augmentation was safe, well-tolerated and effective in antidepressant partial and non-responders, suggesting good feasibility in outpatient settings. Replication in controlled trials is warranted.