Research into evidence-based psychological interventions needs a stronger focus on replicability

Background:It is a precondition for evidence-based practice that research is replicable in a wide variety of clinical settings. Current standards for identifying evidence-based psychological interventions and making recommendations for clinical practice in clinical guidelines include criteria that are relevant for replicability, but a better understanding as well refined definitions of replicability are needed enabling empirical research on this topic. Recent advances on this issue were made in the wider field of psychology and in other disciplines, which offers the opportunity to define and potentially increase replicability also in research on psychological interventions. Method: This article proposes a research strategy for assessing, understanding, and improving replicability in research on psychological interventions. Results/Conclusion: First, we establish a replication taxonomy ranging from direct to conceptual replication adapted to the field of research on clinical interventions, propose study characteristics that increase the trustworthiness of results, and define statistical criteria for successful replication with respect to the quantitative outcomes of the original and replication studies. Second, we propose how to establish such standards for future research, i.e., in order to design future replication studies for psychological interventions as well as to apply them when investigating which factors are causing the (non-)replicability of findings in the current literature

Imagery Rescripting as a stand-alone treatment for posttraumatic stress disorder related to childhood abuse: A randomized controlled trial

Background and objectives: Posttraumatic stress disorder (PTSD) related to childhood abuse (CA) is associated with high symptom complexity. This study examined the efficacy of Imagery Rescripting (ImRs) as a stand-alone treatment versus a sequenced approach with Skills training in Affective and Interpersonal Regulation (STAIR) followed by ImRs for CA-related PTSD.Methods: Outpatients of two mental health clinics with CA-related PTSD (N = 61) were randomly assigned to ImRs (16 sessions;n = 21), STAIR/ImRs (8 STAIR-sessions followed by 16 ImRs-sessions;n = 20), or Waitlist (8 weeks;n = 20). Patients of the waitlist condition were also randomized to the two active conditions for com-parison of STAIR/ImRs (total n for this condition = 31) and ImRs (total n for this condition = 30) and started treatment after waitlist completion. Assessments took place at pre-treatment, after each treatment phase and at 12-week post-intervention follow-up. PTSD symptoms and diagnosis were primary outcome measures, and depression, emotion regulation and interpersonal functioning were secondary outcomes.Results: ImRs showed greater reduction of PTSD severity (effect sizes [ES] 1.40-1.63) than STAIR (ES, 0.23-0.33) as compared to waitlist. When comparing STAIR/ImRs and ImRs directly, (i.e. including re-randomized Waitlist-patients), PTSD symptoms reduced significantly (within condition ES, 1.64-2.10) and improved further to 12 -week follow-up (within-condition ES, 2.33-2.66), with no significant difference between both conditions (be-tween-condition ES, 0.21-0.45). Loss of PTSD diagnosis was achieved by 70% in the ImRs condition and 86% in the STAIR/ImRs condition.Limitations: The sample size was relatively small.Conclusions: Results show that ImRs is an effective treatment for CA-related PTSD, whereby the current data do not convincingly show an additive effect of STAIR

Purpose in life predicts better emotional recovery from negative stimuli

Purpose in life predicts both health and longevity suggesting that the ability to find meaning from life’s experiences, especially when confronting life’s challenges, may be a mechanism underlying resilience. Having purpose in life may motivate reframing stressful situations to deal with them more productively, thereby facilitating recovery from stress and trauma. In turn, enhanced ability to recover from negative events may allow a person to achieve or maintain a feeling of greater purpose in life over time. In a large sample of adults (aged 36-84 years) from the MIDUS study (Midlife in the U.S., http://www.midus.wisc.edu/), we tested whether purpose in life was associated with better emotional recovery following exposure to negative picture stimuli indexed by the magnitude of the eyeblink startle reflex (EBR), a measure sensitive to emotional state. We differentiated between initial emotional reactivity (during stimulus presentation) and emotional recovery (occurring after stimulus offset). Greater purpose in life, assessed over two years prior, predicted better recovery from negative stimuli indexed by a smaller eyeblink after negative pictures offset, even after controlling for initial reactivity to the stimuli during the picture presentation, gender, age, trait affect, and other well-being dimensions. These data suggest a proximal mechanism by which purpose in life may afford protection from negative events and confer resilience is through enhanced automatic emotion regulation after negative emotional provocation

Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial

Background: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. Methods. The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α =.05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. Discussion. The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed. Trial registration. German Register of Clinical Studies (DRKS): DRKS00004749. © 2013 Heber et al.; licensee BioMed Central Ltd

A pilot randomized controlled trial for a videoconference-delivered mindfulness-based group intervention in a nonclinical setting

Technology is increasingly being integrated into the provision of therapy and mental health interventions. While the evidence base for technology-led delivery of mindfulness-based interventions is growing, one approach to understanding the effects of technology-delivered elements includes so-named blended programs that continue to include aspects of traditional face-to-face interaction. This arrangement offers unique practical advantages, and also enables researchers to isolate variables that may be underlying the effects of technology-delivered interventions. The present study reports on a pilot videoconference-delivered mindfulness-based group intervention offered to university students and staff members with wait-list controls. Apart from the first session of the six-week course, the main facilitator guided evening classes remotely via online videoconferencing, with follow-up exercises via email. Participants Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation were taught a variety of mindfulness-based exercises such as meditation, breathing exercises, mindful tasting, as well as the concepts underpinning such practice. Participants completed pre- and post-intervention questionnaires on depression, anxiety, repetitive negative thinking, dysfunctional attitudes, positive and negative affect, self-compassion, compassion for others, and mindfulness. For participants who attended at least five of the six sessions, scores on all outcome measures improved significantly post intervention and remained stable at three-week follow up. The videoconference-delivered mindfulness-based group intervention appears to provide a viable alternative format to standard mindfulness programs where the facilitator and participants need to live in close physical proximity with each other

The effect of twice-weekly versus once-weekly sessions of either imagery rescripting or eye movement desensitization and reprocessing for adults with PTSD from childhood trauma (IREM-Freq): a study protocol for an international randomized clinical trial

Background Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study’s aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated. Methods The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains. Discussion This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome. Trial registration Netherlands Trial Register NL6965, registered 25/04/2018

Associations between sleep problems and posttraumatic stress symptoms, social functioning, and quality of life in refugees with posttraumatic stress disorder

Many patients with posttraumatic stress disorder (PTSD) suffer from sleepproblems, leading to impairments in social functioning and quality of life. Refugees are at high risk for sleep problems due to stressful life circumstances and a high PTSD prevalence. However, limited data on the frequency of sleepproblems in refugees with diagnosed PTSD exist. This study examined the frequency of sleep problems in refugees with PTSD and their associations with symptoms of PTSD. Additionally, we investigated the contribution of sleep problems to social functioning and quality of life. Participants (N=70) were refugees from different countries of origin currently living in Germany. All participants met the criteria for PTSD and completed measures of PTSD symptom severity,subjective sleep problems, social impairment, and quality of life. There was a very high frequency of sleep problems in the sample (100%), and sleep problems were significantly associated with both clinician-rated,r=.47, and self-rated,r=.30, PTSD symptom severity after controlling for overlapping items. Contrary to expectations, sleep problems did not predict social impairment,d=0.16, nor quality of life,d=0.13, beyond the effect of other PTSD symptoms. The findings highlight the widespread frequency of sleep problems among refugees. Future studies should assess the causal nature of the association between sleep problems and measures of psychosocial functioning in more detail and examine its dynamic change over time