An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

BACKGROUND: Depression treatment might be enhanced by ecological momentary interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice.METHODS: Outpatients starting depression treatment at secondary mental health services (N = 161; MIDS-DEPRESSION = 35.9, s.d. = 10.7; MAGE = 32.8, s.d. = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period.RESULTS: Of the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning, and empowerment. Furthermore, the trajectories of the two EMI modules were very similar.CONCLUSIONS: We did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI's promise of effectiveness has not materialized yet.</p

Comparison of Two Ecological Momentary Intervention Modules for Treatment of Depression on Momentary Positive and Negative Affect

Background: Ecological Momentary Assessment (EMA), comprising repeated self-assessments in daily life, have shown promise as an intervention strategy for depression. Whether the content of such assessments influences affect has hardly received attention. The current study consists of two EMA intervention (EMI) modules, enabling us to compare the impact of EMI content on the course of momentary affect during the intervention. Methods: The intervention, implemented as add-on to regular depression treatment, consists of intensive self-monitoring (5x/day, 28 days) and weekly personalized feedback. Patients with depressive complaints (N = 110; M-age = 32.9, SD = 12.2; 44.5% male) were randomly assigned to one of two treatment modules focusing on activities and positive affect ("Do") or on thoughts and negative affect ("Think"). Results: Linear mixed models showed no significant (p > .18) differences between the two modules on both positive and negative affect over time. Across modules positive affect showed an initial decreasing trend, leveling off towards the end of the intervention period. Negative affect did not change significantly over time (p > .06). Limitations: Both modules assessed positive and negative affect, enabling a direct comparison but potentially decreasing the impact of their differential focus. Conclusions: In our sample, the focus of the EMI was not associated with differential effects on momentary affect. This implies that a focus on thoughts and negative affect compared to positive affect and activities may not lead to added adverse effects on mood, which is an often-voiced concern when using EMA in both research and clinical practice

Different Aspects of the Neural Response to Socio-Emotional Events Are Related to Instability and Inertia of Emotional Experience in Daily Life: An fMRI-ESM Study

Emotions are fundamentally temporal processes that dynamically change over time. This temporal nature is inherently involved in making emotions adaptive by guiding interactions with our environment. Both the size of emotional changes across time (i.e., emotional instability) and the tendency of emotions to persist across time (i.e., autocorrelation of emotional experience, emotional inertia) are key features of a person’s emotion dynamics, and have been found central to maladaptive functioning and psychopathology as well as linked to social functioning. However, whether different (neural) mechanisms are underlying these dynamics as well as how they are related to the processing of (socio-) emotional information is to date widely unknown. Using a combination of Experience Sampling methods (ESMs) and fMRI (involving a social feedback paradigm), we examine how emotional instability and inertia in everyday life are associated with different aspects of the neural response to socio-emotional events. The findings indicate that while emotional instability is connected to the response of the core salience network (SN), emotional inertia is associated to responses in the parahippocampal gyrus (PHG) and lateral orbitofrontal cortex (lOFC). This is the first study showing that different aspects of the neural response to socio-emotional events are associated with different aspects of the temporal dynamics of emotion in real life

Effect of Daily Life Reward Loop Functioning on the Course of Depression

Engagement in activities increases positive affect (Reward Path 1), which subsequently reinforces motivation (Reward Path 2), and hence future engagement in activities (Reward Path 3). Strong connections between these three reward loop components are considered adaptive, and might be disturbed in depression. Although some ecological nomentary assessment (EMA) studies have investigated the cross-sectional association between separate reward paths and individuals’ level of depression, no EMA study has looked into the association between individuals’ reward loop strength and depressive symptom course. The present EMA study assessed reward loop functioning (5x/day, 28 days) of 46 outpatients starting depression treatment at secondary mental health services and monitored with the Inventory of Depressive Symptomatology—Self-Report (IDS-SR) during a 7-month period. Results of multilevel regression analyses showed significant within-person associations for Reward Path 1 (b = 0.21, p &lt; .001), Reward Path 2 (b = 0.43, p &lt; .001), and Reward Path 3 (b = 0.20, p &lt; .001). Stronger average reward loops (i.e., within-person mean of all reward paths) did not relate to participants’ improvement in depressive symptoms over time. Path-specific results revealed that Reward Paths 1 and 2 may have partly opposite effects on depressive symptom course. Together, our findings suggest that reward processes in daily life might be best studied separately and that further investigation is warranted to explore under what circumstances strong paths are adaptive or not.</p

Comparing the evidential strength for psychotropic drugs:a Bayesian meta-analysis

Approval and prescription of psychotropic drugs should be informed by the strength of evidence for efficacy. Using a Bayesian framework, we examined (1) whether psychotropic drugs are supported by substantial evidence (at the time of approval by the Food and Drug Administration), and (2) whether there are systematic differences across drug groups. Data from short-term, placebo-controlled phase II/III clinical trials for 15 antipsychotics, 16 antidepressants for depression, nine antidepressants for anxiety, and 20 drugs for attention deficit hyperactivity disorder (ADHD) were extracted from FDA reviews. Bayesian model-averaged meta-analysis was performed and strength of evidence was quantified (i.e. BFBMA). Strength of evidence and trialling varied between drugs. Median evidential strength was extreme for ADHD medication (BFBMA = 1820.4), moderate for antipsychotics (BFBMA = 365.4), and considerably lower and more frequently classified as weak or moderate for antidepressants for depression (BFBMA = 94.2) and anxiety (BFBMA = 49.8). Varying median effect sizes (ESschizophrenia = 0.45, ESdepression = 0.30, ESanxiety = 0.37, ESADHD = 0.72), sample sizes (Nschizophrenia = 324, Ndepression = 218, Nanxiety = 254, NADHD = 189.5), and numbers of trials (kschizophrenia = 3, kdepression = 5.5, kanxiety = 3, kADHD = 2) might account for differences. Although most drugs were supported by strong evidence at the time of approval, some only had moderate or ambiguous evidence. These results show the need for more systematic quantification and classification of statistical evidence for psychotropic drugs. Evidential strength should be communicated transparently and clearly towards clinical decision makers

Patients' experience of an ecological momentary intervention involving self-monitoring and personalized feedback for depression

Experts in clinical mental health research count on personalized approaches based on self-monitoring and self-management to improve treatment efficacy in psychiatry. Among other things, researchers expect that Ecological Momentary Interventions (EMI) based on self-monitoring and personalized feedback will reduce depressive symptoms. Clinical trial findings have, however, been conflicting. A recent trial (ZELF-i) investigated whether depression treatment might be enhanced by an add-on EMI with self-monitoring items and feedback focused on positive affect and activities (Do-module) or on negative affect and thinking patterns (Think-module). There was no statistical evidence that this EMI impacted clinical or functional outcomes beyond the effects of regular care, regardless of module content. In apparent contrast, 86% of the participants who completed the intervention indicated they would recommend it to others. In the present study, we used in-depth interviews (n = 20) to better understand the EMI's personal and clinical benefits and downsides. A thematic analysis of the interviews generated six areas of impact with various subthemes. In line with the trial results, few participants reported behavioral changes or symptom improvement over time; the self-assessments mainly amplified momentary mood, in either direction. The most often mentioned benefits were an increase in self-awareness, insight, and self-management (e.g., a stronger sense of control over complaints). Consistently, these domains received the highest ratings in our evaluation questionnaire (n = 89). Furthermore, the EMI instilled a routine into the days of individuals without regular jobs or other activities. Participants reported few downsides. The experiences were rather similar between the two modules. This study suggests that EMI might contribute to health by helping individuals deal with their symptoms, rather than reducing them. Measures on self-awareness, insight, and self-management should be more emphatically involved in future EMI research

Citation bias and selective focus on positive findings in the literature on the serotonin transporter gene (5-HTTLPR), life stress and depression

Background Caspi et al.'s 2003 report that 5-HTTLPR genotype moderates the influence of life stress on depression has been highly influential but remains contentious. We examined whether the evidence base for the 5-HTTLPR-stress interaction has been distorted by citation bias and a selective focus on positive findings. Method A total of 73 primary studies were coded for study outcomes and focus on positive findings in the abstract. Citation rates were compared between studies with positive and negative results, both within this network of primary studies and in Web of Science. In addition, the impact of focus on citation rates was examined. Results In all, 24 (33%) studies were coded as positive, but these received 48% of within-network and 68% of Web of Science citations. The 38 (52%) negative studies received 42 and 23% of citations, respectively, while the 11 (15%) unclear studies received 10 and 9%. Of the negative studies, the 16 studies without a positive focus (42%) received 47% of within-network citations and 32% of Web of Science citations, while the 13 (34%) studies with a positive focus received 39 and 51%, respectively, and the nine (24%) studies with a partially positive focus received 14 and 17%. Conclusions Negative studies received fewer citations than positive studies. Furthermore, over half of the negative studies had a (partially) positive focus, and Web of Science citation rates were higher for these studies. Thus, discussion of the 5-HTTLPR-stress interaction is more positive than warranted. This study exemplifies how evidence-base-distorting mechanisms undermine the authenticity of research findings

Statistical power in clinical trials of interventions for mood, anxiety, and psychotic disorders

BACKGROUND: Previous research has suggested that statistical power is suboptimal in many biomedical disciplines, but it is unclear whether power is better in trials for particular interventions, disorders, or outcome types. We therefore performed a detailed examination of power in trials of psychotherapy, pharmacotherapy, and complementary and alternative medicine (CAM) for mood, anxiety, and psychotic disorders.METHODS: We extracted data from the Cochrane Database of Systematic Reviews (Mental Health). We focused on continuous efficacy outcomes and estimated power to detect predetermined effect sizes (standardized mean difference [SMD] = 0.20-0.80, primary SMD = 0.40) and meta-analytic effect sizes (ESMA). We performed meta-regression to estimate the influence of including underpowered studies in meta-analyses.RESULTS: We included 256 reviews with 10 686 meta-analyses and 47 384 studies. Statistical power for continuous efficacy outcomes was very low across intervention and disorder types (overall median [IQR] power for SMD = 0.40: 0.32 [0.19-0.54]; for ESMA: 0.23 [0.09-0.58]), only reaching conventionally acceptable levels (80%) for SMD = 0.80. Median power to detect the ESMA was higher in treatment-as-usual (TAU)/waitlist-controlled (0.49-0.63) or placebo-controlled (0.12-0.38) trials than in trials comparing active treatments (0.07-0.13). Adequately-powered studies produced smaller effect sizes than underpowered studies (B = -0.06, p ⩽ 0.001).CONCLUSIONS: Power to detect both predetermined and meta-analytic effect sizes in psychiatric trials was low across all interventions and disorders examined. Consistent with the presence of reporting bias, underpowered studies produced larger effect sizes than adequately-powered studies. These results emphasize the need to increase sample sizes and to reduce reporting bias against studies reporting null results to improve the reliability of the published literature.</p