Imaginal exposure exacerbation revisited: Deconstructing patient characteristics associated with worse reactions to the initiation of imaginal exposure in PTSD.

OBJECTIVE: This study examines whether imaginal exposure leads to symptom exacerbation, systematically comparing individuals who received prolonged exposure (PE) to those who received pharmacotherapy. The study also examined whether common clinical features increase the likelihood of symptom exacerbation. METHOD: In 151 men and women with PTSD, we examined rates of reliable exacerbation of PTSD and depression symptoms after initiation of imaginal exposure and compared it to those receiving sertraline. We also examined relationships between exacerbation, treatment outcome, dropout, imaginal distress, and specific clinical features, including co-occurring MDD, multiple co-occurring disorders, childhood sexual abuse as target trauma, and a history of childhood physical or sexual abuse. RESULTS: Symptom exacerbation was not more common in PE compared to sertraline, not associated with higher dropout, or predictive of worse outcome. Those with co-occurring depression or multiple disorders, a target trauma of child sexual abuse, or a history of child abuse reported functionally equivalent peak distress at onset of imaginal as those without these characteristics. These factors did not lead to more exacerbation or worse adherence. CONCLUSION: Exacerbation was not specific to PE and patients with and without symptom worsening showed comparable treatment gains, suggesting symptom exacerbation may reflect a common clinical process.

Resilience is spreading: Mental health within the COVID-19 pandemic.

The COVID-19 global pandemic is in many ways unchartered mental health territory, but history would suggest that long-term resilience will be the most common outcome, even for those most directly impacted by the outbreak. We address 4 common myths about resilience and discuss ways to systematically build individual and community resiliency. Actively cultivating social support, adaptive meaning, and direct prosocial behaviors to reach the most vulnerable can have powerful resilience promoting effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Relationship between placebo response rate and clinical trial outcome in bipolar depression.

The aim of this work is to investigate the impact of placebo response rates on the relative risk of response to drug versus placebo in randomized, double-blind, placebo-controlled clinical trials of pharmacological therapy in Bipolar Depression (BPD). Medline/PubMed publication databases were searched for randomized, double-blind, placebo-controlled trials of oral drugs used as monotherapy for the treatment of BPD. The search was limited to articles published between January 1980 and September 2015. Data extracted from 12 manuscripts and one poster with yet unpublished results, representing a total of 17 clinical trials were pooled (n = 6578). Pooled response rates for drug and placebo were 55.1% and 39.2%, corresponding to a risk ratio (RR) for responding to active treatment versus placebo of 1.29 (p < 0.001). Clinical response was defined as a 50% or greater reduction in depression scores, baseline to endpoint. A higher placebo response rate correlated with a significantly lower RR of responding to pharmacotherapy versus placebo (p = 0.002). The pooled drug and placebo response rates for studies with a placebo response rate ≤ 30% were 50.5% versus 26.6%, while corresponding values from studies with a placebo response rate >30 were 55.0% versus 41.6%. These results suggest that the relative efficacy of the active drug compared to placebo in clinical trials for BPD is highly heterogeneous across studies with different placebo response rates, with a worse performance in showing a superiority of the drug versus placebo for studies with placebo response rates >30%. It is important to maintain placebo response rates below this critical threshold, since this is one of the most challenging obstacles for new treatment development in BPD.

A double-blind placebo-controlled trial of maca root as treatment for antidepressant-induced sexual dysfunction in women.

Objective. We sought to demonstrate that maca root may be an effective treatment for antidepressant-induced sexual dysfunction (AISD) in women. Method. We conducted a 12-week, double-blind, placebo-controlled trial of maca root (3.0 g/day) in 45 female outpatients (mean age of 41.5 ± 12.5 years) with SSRI/SNRI-induced sexual dysfunction whose depression remitted. Endpoints were improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ). Results. 45 of 57 consented females were randomized, and 42 (30 premenopausal and 12 postmenopausal women) were eligible for a modified intent-to-treat analysis based on having had at least one postmedication visit. Remission rates by the end of treatment were higher for the maca than the placebo group, based on attainment of an ASEX total score ≤ 10 (9.5% for maca versus 4.8% for placebo), attaining an MGH-SFQ score ≤ 12 (30.0% for maca versus 20.0% for placebo) and reaching an MGH-SFQ score ≤ 8 (9.5% for maca versus 5.0% for placebo). Higher remission rates for the maca versus placebo group were associated with postmenopausal status. Maca was well tolerated. Conclusion. Maca root may alleviate SSRI-induced sexual dysfunction in postmenopausal women. This trial is registered with NCT00568126.

Predictors of placebo response in bipolar depression.

The aim of this work is to investigate placebo response rates in placebo-controlled randomized clinical trials (RCTs) of pharmacological therapy in bipolar depression (BPD) and to identify predictors of placebo response and clinical trial outcome in BPD. Medline/PubMed publication databases were searched for RCTs of oral drugs used as monotherapy for the treatment of BPD, published between January 1980 and September 2013. Data extracted from 12 manuscripts and one poster, representing a total of 17 clinical trials, were pooled. Pooled response rates for drug and placebo were 55.1 and 39.2%, corresponding to a risk ratio for responding to active treatment versus placebo of 1.29 (P<0.001). The probability of receiving placebo and trial duration correlated with the response rate to placebo. A meta-regression showed that trial duration and baseline severity correlated with the risk ratio of responding to drug versus placebo. There was a trend toward statistical significance for a greater probability of receiving placebo to predict greater drug-placebo 'separation'. In conclusion, several modifiable factors, specifically the probability of receiving placebo, baseline illness severity, and trial duration, correlate with placebo response rates and/or clinical trial outcome in RCTs of pharmacotherapy for BPD, and should be taken into account when designing studies for BPD.

Reliability and validity of the Symptoms of Depression Questionnaire (SDQ).

Current measures for major depressive disorder focus primarily on the assessment of depressive symptoms, while often omitting other common features. However, the presence of comorbid features in the anxiety spectrum influences outcome and may effect treatment. More comprehensive measures of depression are needed that include the assessment of symptoms in the anxiety-depression spectrum. This study examines the reliability and validity of the Symptoms of Depression Questionnaire (SDQ), which assesses irritability, anger attacks, and anxiety symptoms together with the commonly considered symptoms of depression. Analysis of the factor structure of the SDQ identified 5 subscales, including one in the anxiety-depression spectrum, with adequate internal consistency and concurrent validity. The SDQ may be a valuable new tool to better characterize depression and identify and administer more targeted interventions.