Mediators Of Treatment Outcome Research Articles

How did the Treatment Work for Robin? And for Dylan? Studying Individual Youth Treatment Mediators Using Single-Case Experimental Designs

Study of individual treatment mechanisms in youth interventions facilitates evidence-based development, selection and implementation of treatment components that are most effective for each individual child. This position paper aims to bring together two important topics from the area of youth intervention research: mediators of treatment outcomes and single-case experimental design methodology. We start by outlining the benefits of studying within-person mechanisms and propose how statistical mediation analysis and single-case methods can be integrated to enable this type of research. Further, we review existing methodology for the study of individual youth treatment mechanisms and provide recommendations for the clinical practice research.

Relations between higher- and lower-order alcohol and cannabis expectancies and simultaneous use frequency among undergraduate dual users

Background Simultaneous alcohol and cannabis (i.e. marijuana; [SAM]) use is prevalent among college students. There is limited research on expectancy effects for SAM use, which are known correlates of use frequency and mediators of treatment outcomes. We examined the unique associations of both positive and negative alcohol and cannabis expectancies with frequency of SAM use among college students. Method Participants were 1012 college students (70.9% female, 51.8% white, M age = 19.63) from seven US universities who reported past-month alcohol and cannabis use (77.2% of the sample reported SAM use). Students completed measures of past-month typical weekly alcohol and cannabis frequency and quantity, alcohol and cannabis expectancies, and SAM frequency through an online self-reported survey. Results A negative binomial regression revealed that higher-order positive, but not negative, alcohol and cannabis expectancies were significant predictors of SAM frequency above and beyond frequency of alcohol and cannabis use, biological sex, and whether the survey was completed pre- or post-COVID-19 campus closures. Specifically, higher frequency SAM use was associated with weaker positive alcohol and stronger positive cannabis expectancies. A second negative binomial regression including lower-order expectancies found that SAM frequency was associated with weaker social and cognitive and behavioral impairment alcohol expectancies and stronger sexual and social facilitation cannabis and liquid courage alcohol expectancies, specifically. Conclusions Results highlight the importance of comprehensively examining both higher- and lower-order alcohol and cannabis expectancies when examining SAM frequency, and provide avenues of targeted intervention to reduce SAM use among dual users.

Mediators and Theories of Change in Psychotherapy for Young People With Personality Disorders: A Systematic Review Protocol.

Background: Personality disorders (PDs) are a severe health issue already prevalent among adolescents and young adults. Early detection and intervention offer the opportunity to reduce disease burden and chronicity of symptoms and to enhance long-term functional outcomes. While psychological treatments for PDs have been shown to be effective for young people, the mediators and specific change mechanisms of treatment are still unclear.Aim: As part of the “European Network of Individualized Psychotherapy Treatment of Young People with Mental Disorders” (TREATme), funded by the European Cooperation in Science and Technology (COST), we will conduct a systematic review to summarize the existing knowledge on mediators of treatment outcome and theories of change in psychotherapy for young people with personality disorders. In particular, we will evaluate whether mediators appear to be common or specific to particular age groups, treatment models, or outcome domains (e.g., psychosocial functioning, life quality, and adverse treatment effects).Method: We will follow the reporting guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement recommendations. Electronic databases (PubMed and PsycINFO) have been systematically searched for prospective, longitudinal, and case–control designs of psychological treatment studies, which examine mediators published in English. Participants will be young people between 10 and 30years of age who suffer from subclinical personality symptoms or have a personality disorder diagnosis and receive an intervention that aims at preventing, ameliorating, and/or treating psychological problems.Results: The results will be published in a peer-reviewed journal and at conference presentations and will be shared with relevant stakeholder groups. The data set will be made available to other research groups following recommendations of the open science initiative. Databases with the systematic search will be made openly available following open science initiatives. The review has been registered in PROSPERO (evaluation is pending, registration number ID 248959).Implications: This review will deliver a comprehensive overview on the empirical basis to contribute to the further development of psychological treatments for young people with personality disorders.

The Mediator Effect of Personality on the Relationship Between Symptomatic Impairment and Treatment Outcome in Eating Disorders.

Features of personality disorders (PDs) have been found to explain meaningful variance in the onset, maintenance, and symptomatic presentation of eating disorders (EDs), and a co-occurent personality pathology is commonly associated with poorer response to ED treatment. The “pathoplasty model” of the relationship between personality and EDs implies that, once both conditions are established, they are likely to interact in ways that modify therapy outcome; however, to date, no studies have explored overall personality functioning, and especially PD clusters, as a mediator of treatment outcome. The present study aimed at conjointly exploring the associations between personality functioning and PDs, respectively, with pre-treatment ED symptomatic impairment and therapy outcome; and the mediating role of personality variables. At treatment onset, a sample of 107 women with ED problems were evaluated using both the Structured Clinical Interview for DSM-5 (SCID-5-CV) and the Shedler-Westen Assessment Procedure-200 (SWAP-200)—a clinician-rated procedure to dimensionally assess personality. Participants were also asked to complete self-report questionnaires on overall ED symptomatology, symptoms of binge eating and purging behaviors, and therapy outcome. The findings showed that, over and above the categorical ED diagnosis, the SWAP-200 healthy personality functioning score mediated the relationship between baseline ED symptom severity and therapy outcome, as well as the association between baseline bulimic symptoms and treatment outcome; furthermore, SWAP-200 Cluster B PD scores mediated the link between baseline binge eating and purging symptoms and therapy outcome, whereas scores in Clusters A and C showed no significant effects. The findings suggest that personality-based outcome research may improve treatment effectiveness in this difficult-to-treat population.

The alliance mediates outcome in cognitive–behavioral therapy for social anxiety disorder, but not in attention bias modification

Objective: The aim of the current study was to examine changes in the therapeutic alliance and its role as a mediator of treatment outcome in cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) compared to attention bias modification (ABM). Method: Patients were randomized to 16–20 sessions of CBT (n = 33) or 8 sessions of ABM (n = 17). Patient-rated alliance and self-reported social anxiety were measured weekly and evaluator-rated social anxiety was measured monthly. Results: Early alliance predicted greater subsequent anxiety reduction in CBT but not in ABM. The alliance increased and weekly improvements in alliance predicted weekly contemporaneous and subsequent decreases in anxiety only in CBT. Decreases in anxiety did not predict subsequent improvements in alliance. Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM. Conclusions: The results highlight the importance of the alliance in CBT for SAD. Further studies should examine the role of alliance alongside additional mediators to better understand differential mechanisms in CBT and ABM.

A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of eye movement desensitization and reprocessing (EMDR) and integrated EMDR-Dialectical Behavioural Therapy (DBT) in the treatment of patients with post-traumatic stress disorder and comorbid (Sub)clinical borderline personality disorder: study design

BackgroundComorbidity between Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) is high. There is growing motivation among clinicians to offer PTSD treatments – such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD. However, a large subgroup with comorbid BPD does not sufficiently respond to PTSD treatment and is more likely to be excluded or to dropout from treatment. Dialectical Behaviour Therapy (DBT) for BPD is well established and although there is some evidence that DBT combined with DBT Prolonged Exposure (DBT + DBT PE) is twice as effective in reducing PTSD symptoms than DBT alone, the comparative efficacy of integrated PTSD-DBT and PTSD-only treatment has not been investigated yet. The current study will therefore evaluate the comparative clinical efficacy and cost-effectiveness of EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD. Moreover, it is not clear yet what treatment works best for which individual patient. The current study will therefore evaluate neurobiological predictors and mediators of the individual response to treatment.MethodA randomized controlled trial comparing the clinical efficacy and cost-effectiveness of integrated EMDR-DBT (n = 63) and EMDR-only (n = 63) in treatment-seeking adult patients with PTSD and comorbid (sub)clinical BPD. In addition, neurobiological predictors and mediators of treatment outcome, such as hair cortisol, FKBP5 and BDNF protein levels and FKBP5 and BDNF methylation status, are measured through hair and blood samples.DiscussionThis is the first study to compare the clinical efficacy and cost-effectiveness of integrated EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD, while simultaneously identifying individual predictors and mediators of treatment response. Results will reveal which treatment works best for which individual patient, thereby guiding individual treatment choices and personalizing psychiatry.Trial registrationClinical Trials, NCT03833453. Retrospectively registered, 15 March 2019.

Persistence targeted smoking cessation for smokers with schizophrenia or schizoaffective disorder: a feasibility study

AbstractIntroductionIndividuals with schizophrenia are more likely to smoke and less likely to quit smoking than those without schizophrenia. Because task persistence is lower in smokers with than without schizophrenia, it is possible that lower levels of task persistence may contribute to greater difficulties in quitting smoking observed among smokers with schizophrenia.AimsTo develop a feasible and acceptable intervention for smokers with schizophrenia.MethodsParticipants (N = 24) attended eight weekly individual cognitive behavioral therapy sessions for tobacco use disorder with a focus on increasing task persistence and received 10 weeks of nicotine patch.ResultsIn total, 93.8% of participants rated the intervention as at least a 6 out of 7 regarding how ‘easy to understand’ it was and 81.3% rated the treatment as at least a 6 out of 7 regarding how helpful it was to them. A total of 62.5% attended at least six of the eight sessions and session attendance was positively related to nicotine dependence and age and negatively related to self-efficacy for quitting.DiscussionThis intervention was feasible and acceptable to smokers with schizophrenia. Future research will examine questions appropriate for later stages of therapy development such as initial efficacy of the intervention and task persistence as a mediator of treatment outcome.

Harnessing the Healing Power of Relationships in Trauma Recovery: a Systematic Review of Cognitive-Behavioral Conjoint Therapy for PTSD

The goal of this systematic review was to examine the empirical literature on cognitive-behavioral conjoint therapy for PTSD (CBCT). The aims were to (1) review the efficacy of CBCT for PTSD, relationship satisfaction, and related symptoms; (2) describe novel adaptations to the treatment; and (3) identify potential moderators and mediators of treatment outcomes. A systematic search of peer-reviewed publications was conducted across three databases (PsycINFO, PubMed, and SCOPUS). Relevant publications were rated by two authors using a validated checklist. Fourteen articles met inclusion criteria. Quality ratings ranged from “fair” to “good”. The majority of studies were uncontrolled designs; no studies compared CBCT to an active control condition. Three studies adapted standard CBCT. Nearly all studies found improvements in patient- and partner-rated PTSD symptoms and patient depression, anxiety, and anger. Findings on relationship satisfaction and partner accommodation as outcomes were somewhat mixed. Baseline relationship satisfaction, partner accommodation, and social support moderated outcomes. Overall, CBCT has demonstrated initial efficacy for PTSD and comorbid problems. Future studies should examine moderators and mediators to answer how and for whom this treatment works. Controlled trials on novel adaptations to CBCT are also needed.

Mindfulness and cognitive behavior therapy for provoked vestibulodynia: Mediators of treatment outcome and long-term effects.

Provoked vestibulodynia (PVD) is a chronic vulvo-vaginal pain condition affecting 8% of premenopausal women. Cognitive-behavioral therapy (CBT) is effective in managing pain and associated sexual and psychological symptoms, and a recent study found group mindfulness-based cognitive therapy (MBCT) to be equivalent. Our goal was to examine the long-term outcomes of these treatments and to explore mediators of change. Participants were 130 women diagnosed with PVD who had participated in a clinical trial comparing 8 weeks of group CBT to 8 weeks of group MBCT. Data were collected at pretreatment, posttreatment, and at 6- and 12-month follow-up periods. Outcomes focused on (a) pain with vaginal penetration, (b) pain elicited with a vulvalgesiometer, and (c) sex-related distress. Mediators of interest included pain acceptance (both pain willingness and activities engagement), self-compassion, self-criticism, mindfulness, decentering, and pain catastrophizing. All improvements in the 3 outcomes were retained at 12-month follow-up, with no group differences. Pain catastrophizing, decentering, and chronic pain acceptance (both scales) were mediators of improvement common to both MBCT and CBT. Changes in mindfulness, self-criticism, and self-compassion mediated improvements only in the MBCT group. Both MBCT and CBT are effective for improving symptoms in women with PVD when assessed 12 months later. The findings have implications for understanding common and potentially distinct pathways by which CBT and MBCT improve pain and sex-related distress in women with PVD. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya

BackgroundMental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.Methods/designWe will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale –up.DiscussionThe results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information – a critical gap for addressing a leading global cause of disability.Trial registrationClinicalTrials.govNCT03466346, registered March 15, 2018.

Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial

BackgroundPTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear. Methods/designMilitary personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible. Participants were randomly assigned to 9 sessions of exposure therapy (VRE or PE) and medication (50 mg DCS or placebo). Participants were treated at three geographically diverse sites. Participants were re-assessed at 3-months post-treatment. The co-primary hypotheses are that (1) DCS will augment response to exposure therapy (both VRE and PE) on PTSD symptoms; (2) VRE will be associated with greater improvement than PE. Genetic and psychophysiological markers will be evaluated as potential moderators and mediators of treatment outcomes as well as secondary outcomes. DiscussionThis study is the first to compare the relative efficacy of DCS-augmented VRE versus PE on PTSD symptoms. The design has several advantages: participants received an active, effective treatment and predictors of response to treatment included genetic and psychobiological measures. The results may directly influence the future delivery of services, and contribute to the development of a standardized treatment protocol.Trial registration: NCT01352637.

Exploring relationships as mediators of treatment outcomes among commercially sexually exploited youth

BackgroundResearch indicates that youth exposed to commercial sexual exploitation tend to have extensive histories of trauma, including physical abuse, sexual abuse, and neglect, which increases their vulnerability to exploitation. Trauma literature finds youth who present to treatment with greater behavioral health needs tend to have higher trauma scores than youth with fewer behavioral health needs (Copeland et al., 2007; Finkelhor et al., 2007). ObjectiveThere is, however, limited research on the role of youth strengths as a buffer against the outcomes associated with trauma. With this in mind, the purpose of this study was to examine the relationship between Adverse Childhood Experiences (ACE scores) and youth outcomes such as risk behaviors, behavioral needs, and impairment in functioning across major life domains. Secondly, we explored how this relationship might be better explained by examining youth strengths as mediators—specifically, peer relationships and the stability of significant relationships in the youth’s life. Participants and settingData on clients served in a treatment program specialized for commercially sexually exploited youth were used for this research. ResultsResults indicated that youth with higher ACE scores had a greater number of risk behaviors, behavioral needs, and impairment in functioning across major life domains. Findings of the mediation analysis provide some support that peer relationships and relationship stability, at least in part, mediates the relationship between ACEs and youth outcomes. Post hoc analyses indicated youth strengths mediated 9–18% of the total effect of ACE scores on youth outcomes. ConclusionsDeveloping peer relationships and sustaining significant relationships can mitigate some of the adverse effects of trauma experienced by exploited youth.

Mechanisms of Change in the Prevention of Depression: An Indicated School-Based Prevention Trial at the Transition to High School

Depression represents a major public health concern, and prevalence increases significantly during adolescence. The high school transition may exacerbate the risk of depression for youth with pre-existing vulnerability. The High School Transition Program (HSTP) is a brief, skills-based intervention that has demonstrated efficacy in preventing depression in adolescents. The current study aimed to evaluate the theorized mechanisms of change of the HSTP intervention by testing a multiple mediation model including school attachment (SA) and self-esteem (SE) as two mediators of treatment outcomes. Students (N= 497; 61.5% girls) with elevated depressive symptoms, identified for the intervention program via an eighth-grade screening, were randomized to a brief intervention (n= 247) or the HSTP (n= 233) from 2003 to 2008. Participants completed measures at five time points. The first assessment occurred at the start of the second semester of eighth grade and the last assessment occurred at the end of ninth grade. A multiple mediation model tested whether SA and SE contributed to changes in depression for youth in the HSTP. The mediation model, including contemporaneously assessed SE and SA, was not supported. There was evidence of sequential mediation, such that students who participated in the HSTP intervention reported higher SA, which in turn predicted improved SE, and in turn contributed to amelioration of depressive symptoms. The HSTP intervention ameliorated depressive symptoms by targeting factors specific to the school transition (ie, SA). Results suggest youth at risk for depression may benefit from prevention efforts that enhance students' capacity to effectively manage identified environmental stressors, such as school transitions. Middle School to High School Transition Project: Depression and Substance Abuse Prevention; https://clinicaltrials.gov/; NCT00071513.

Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment

BackgroundChildhood abuse related posttraumatic stress disorder (CA-PTSD) is associated with a high burden of disease and with treatment response rates that leave room for improvement. One of the treatments for PTSD, prolonged exposure (PE), is effective but has high drop-out rates and remission rates are relatively low. An intensified form of PE (iPE) was associated with good response and low drop-out rates in PTSD and has not yet been tested in a controlled trial in CA-PTSD. Phase-based treatment (PBT), in which PE is preceded by skills training may improve overall outcomes in this population. We will assess the effectiveness and cost-effectiveness of standard PE, iPE and PBT in patients with CA-PTSD.Methods/designMulti-center randomized controlled trial. Treatment conditions are: prolonged exposure (PE; maximum of 16 sessions in 16 weeks); intensified PE (iPE; maximum of 12 sessions in four weeks and two booster sessions); phase-based treatment (PBT; maximum of eight sessions skills training followed by eight sessions PE in 16 weeks).Primary outcome: Clinician-rated PTSD symptom severity. Secondary outcomes: loss of PTSD diagnosis, self-reported PTSD symptom severity, comorbid symptom severity and quality of life. Moreover, we will examine cost-effectiveness and moderators and mediators of treatment outcome. Target population: adults with CA-PTSD (N = 150). Assessments in weeks 0, 4, 8, 16, 26 and 52.DiscussionGiven that no consensus yet exists about the treatment guidelines for patients with CA-PTSD, the present study may have important implications for the treatment of CA-PTSD.Trail registrationRegistered at C.C.M.O. on Sept 7, 2016 (NL57984.058.16); retrospectively registered at June 21, 2017 at clinicaltrials.gov identifier: NCT03194113.

Treatments for bulimia nervosa: a network meta-analysis

Bulimia nervosa (BN) is a severe eating disorder that can be managed using a variety of treatments including pharmacological, psychological, and combination treatments. We aimed to compare their effectiveness and to identify the most effective for the treatment of BN in adults. A search was conducted in Embase, Medline, PsycINFO, and Central from their inception to July 2016. Studies were included if they reported on treatments for adults who fulfilled diagnostic criteria for BN. Only randomised controlled trials (RCTs) that examined available psychological, pharmacological, or combination therapies licensed in the UK were included. We conducted a network meta-analysis (NMA) of RCTs. The outcome analysed was full remission at the end of treatment. We identified 21 eligible trials with 1828 participants involving 12 treatments, including wait list. The results of the NMA suggested that individual cognitive behavioural therapy (CBT) (specific to eating disorders) was most effective in achieving remission at the end of treatment compared with wait list (OR 3.89, 95% CrI 1.19-14.02), followed by guided cognitive behavioural self-help (OR 3.81, 95% CrI 1.51-10.90). Inconsistency checks did not identify any significant inconsistency between the direct and indirect evidence. The analysis suggested that the treatments that are most likely to achieve full remission are individual CBT (specific to eating disorders) and guided cognitive behavioural self-help, although no firm conclusions could be drawn due to the limited evidence base. There is a need for further research on the maintenance of treatment effects and the mediators of treatment outcome.

Predictors, Moderators, and Mediators of Treatment Outcome Following Manualised Cognitive-Behavioural Therapy for Eating Disorders: A Systematic Review.

This systematic review synthesised the literature on predictors, moderators, and mediators of outcome following Fairburn's CBT for eating disorders. Sixty-five articles were included. The relationship between individual variables and outcome was synthesised separately across diagnoses and treatment format. Early change was found to be a consistent mediator of better outcomes across all eating disorders. Moderators were mostly tested in binge eating disorder, and most moderators did not affect cognitive-behavioural treatment outcome relative to other treatments. No consistent predictors emerged. Findings suggest that it is unclear how and for whom this treatment works. More research testing mediators and moderators is needed, and variables selected for analyses need to be empirically and theoretically driven. Future recommendations include the need for authors to (i) interpret the clinical and statistical significance of findings; (ii) use a consistent definition of outcome so that studies can be directly compared; and (iii) report null and statistically significant findings. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.

Alcohol-Focused Behavioral Couple Therapy.

Alcohol Behavioral Couple Therapy (ABCT) has emerged over the last 30years as a highly efficacious treatment for those with alcohol use disorders. This review highlights the historical and conceptual underpinnings of ABCT, as well as the specific treatment elements and structure. Proposed active ingredients, moderators, and mediators of treatment outcome are discussed. Efficacy is evaluated for reductions in identified patient drinking, improved relationship functioning, and reductions in intimate partner violence. Adaptations of ABCT for substances other than alcohol are described. Other adaptations, including brief interventions, interventions addressing PTSD and TBI along with alcohol use, and interventions deliverable via technology platforms are described. Additional cost-benefit and cost-effectiveness findings supporting the economic value of ABCT are noted. Future directions for research in this area include possible adaptations for female identified patients, nontraditional couples, LGBT partners and dyads involving nonintimate partner relationships. The development of more flexible models and enhanced dissemination strategies may improve clinical uptake and utility as well as increasing the feasibility of this treatment for integrated healthcare settings.

Messages for Clinicians: Moderators and Mediators of Treatment Outcome in Randomized Clinical Trials.

Many problems in randomized clinical trial design, execution, analysis, presentation and interpretation stem in part from an inadequate understanding of the roles of moderators and mediators of treatment outcome. As a result, 1) the results of clinical research are slow to have an impact on clinical decision making and thus to benefit patients; 2) it is difficult for clinicians or patients to apply randomized clinical trial results comparing two treatments (treatment versus control); 3) when such trials are conducted at various sites, the results often do not replicate; 4) when the results influence clinical decision making, the results clinicians obtain do not match what researchers report; and 5) the treatment effects comparing treatment and control conditions, particularly for psychiatric treatments, often seem trivial. In this review article, the author reviews and integrates the methodological literature concerning dealing with covariates in trials to emphasize their impact on clinical decision making. The goal of trials should ultimately be to establish who should get the treatment condition rather than the control condition (moderators) and to determine how to obtain the best outcomes with whatever is the preferred treatment (mediators). The author makes recommendations to clinicians as to which trials might best be ignored and which carefully considered, and urges clinical researchers to focus on studies best designed to reduce the burden of mental illness on patients.

Procrastination and Self-Efficacy Among Intravenous Drug Users on a Methadone Maintenance Program in Sari City, Iran, 2013.

Background:Self-efficacy is the belief that one has the ability to implement the behaviors needed to produce a desired effect. There has been growing interest in the role of self-efficacy as a predictor and/or mediator of treatment outcome in a number of domains. Procrastination is a self-regulatory failure, defined as the voluntary delay of an intended course of action despite expecting to be worse off for the delay. Behavioral procrastination is a self-sabotage strategy that allows people to shift blame and avoid action; the decisional procrastination strategy is to put off making a decision when dealing with conflicts or choices. Procrastination has a great role in quitting drug addiction.Objectives:The aim of this study was to determine the relationship between procrastination and self-efficacy and other factors among intravenous drug users.Patients and Methods:This cross-sectional study was conducted on 178 intravenous drug users in the behavioral disease counseling, health center in Sari city, Mazandaran province, Iran, in 2013. The samples were selected through census sampling, descriptive and inferential statistics were used to measure the properties of distribution that depicts a set of data shown as frequency distribution tables, while for the mean and standard deviation, chi-square, Fisher and Spearman-Brown coefficients were used to analyze the data.Results:The mean age of the participants was 43 years. Seventy-two percent of them were married and opium was the first drug used. The first substance used in them was 54% of opium, 33% cannabis and 5% alcohol and 79% smoking. The reason of the first drug use in 32% of the subjects was temptation and in 10% a friend’s influence. The mean age of the first drug use was 23 years, and the frequency was 2 times per day. All of them had relapse at least once. Seven percent of them currently use other materials (2% crystal, 5% alcohol and opium and crack) both in methadone treatment. Behavioral procrastination in 60.5% of them and decisional procrastination in 62% is from low to average range. There was a significant relationship between relapse and self-efficacy as well as between self-efficacy and the age of the first drug use, drug dose, and procrastination for treatment, marriage, employment and job. Also, the relationship between behavioral procrastination and self-efficacy was significant and inverse.Conclusions:This study found a significant difference between procrastination and self-efficacy as well as other related factors. It is important to include drug users and the society organizations representing them in every stage of the governmental policy and program development process to make them responsive to the needs of the community.

Therapist-Aided Exposure for Women with Lifelong Vaginismus: Mediators of Treatment Outcome: A Randomized Waiting List Control Trial.

Therapist-aided exposure seems an effective treatment for lifelong vaginismus, but mechanisms of action have not yet been established. The purpose of the present study was to investigate whether treatment outcome of a therapist-aided exposure treatment was mediated by changes in positive and negative penetration beliefs or feelings of sexual disgust. Participants with lifelong vaginismus were allocated at random to a 3-month exposure (n = 35) or a waiting list control condition (n = 35). Full intercourse was assessed daily during 12 weeks. Secondary outcome measures (complaints about vaginismus and coital pain) were assessed at baseline and after 12 weeks. Possible mediators: penetration beliefs (catastrophic pain beliefs, genital incompatibility beliefs, perceived control beliefs) and feelings of sexual disgust were assessed at baseline and 6 weeks. Treatment outcome (coital frequency, symptoms of vaginismus, and coital pain) at 12 weeks was mediated by changes in negative and positive penetration beliefs at 6 weeks, in particular by more pronounced reduction of catastrophic pain penetration beliefs. No evidence was found that changes in feelings of sexual disgust mediated treatment outcome. The results strongly suggest that therapist-aided exposure affects negative penetration beliefs and that these changes in negative penetration beliefs mediate treatment outcome in women with lifelong vaginismus. Implications for treatment are discussed.