Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

The Effect of Dissemination Pathways on Uptake and Relative Costs for a Transdiagnostic, Self-guided Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation: Comparative Implementation Study.

BACKGROUND: Self-guided web-based programs are effective; however, inadequate implementation of these programs limits their potential to provide effective and low-cost treatment for common mental health problems at scale. There is a lack of research examining optimal methods for the dissemination of web-based programs in the community. OBJECTIVE: This study aimed to compare the uptake, reach, relative costs, and adherence associated with 3 community-based pathways for delivering a low-intensity web-based transdiagnostic mental health program. The 3 dissemination pathways were social media advertising, advertising in general practice, and advertising in pharmacies. METHODS: Participants were recruited on the web, from general practices, or from community pharmacies; completed a screener for psychological distress; and were offered the 4-week FitMindKit program-a 12-module psychotherapeutic intervention. Uptake was defined as the number of participants who enrolled in the web-based program; reach was defined as the rate of uptake per exposure; and costs were calculated based on staff time, equipment, and advertising. Adherence was assessed as the number of modules of FitMindKit completed by the participants. RESULTS: Uptake comprised 1014 participants who were recruited through the 3 dissemination pathways: on the web (991/1014, 97.73%), in general practice (16/1014, 1.58%), and in pharmacy (7/1014, 0.69%). Reach was highest for social media: 1 in every 50 people exposed to web-based advertising took up the intervention compared with 1 in every 441 in general practitioner clinics and 1 in every 1708 in pharmacies. The dissemination cost was US $4.87 per user on social media, US $557 per user for general practitioner clinics, and US $1272 per user for pharmacy dissemination. No significant differences in adherence were observed between the conditions, whereas all pathways showed an underrepresentation of men and linguistic diversity. CONCLUSIONS: The web-based dissemination pathway was the most efficient and cost-effective for delivering a self-guided internet-based mental health program to people in the community. More research is needed to identify how best to engage men and those with culturally diverse backgrounds in web-based interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001688279; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376113.

A Data-Driven Clustering Method for Discovering Profiles in the Dynamics of Major Depressive Disorder Using a Smartphone-Based Ecological Momentary Assessment of Mood.

Background: Although major depressive disorder (MDD) is characterized by a pervasive negative mood, research indicates that the mood of depressed patients is rarely entirely stagnant. It is often dynamic, distinguished by highs and lows, and it is highly responsive to external and internal regulatory processes. Mood dynamics can be defined as a combination of mood variability (the magnitude of the mood changes) and emotional inertia (the speed of mood shifts). The purpose of this study is to explore various distinctive profiles in real-time monitored mood dynamics among MDD patients in routine mental healthcare. Methods: Ecological momentary assessment (EMA) data were collected as part of the cross-European E-COMPARED trial, in which approximately half of the patients were randomly assigned to receive the blended Cognitive Behavioral Therapy (bCBT). In this study a subsample of the bCBT group was included (n = 287). As part of bCBT, patients were prompted to rate their current mood (on a 1-10 scale) using a smartphone-based EMA application. During the first week of treatment, the patients were prompted to rate their mood on three separate occasions during the day. Latent profile analyses were subsequently applied to identify distinct profiles based on average mood, mood variability, and emotional inertia across the monitoring period. Results: Overall, four profiles were identified, which we labeled as: (1) "very negative and least variable mood" (n = 14) (2) "negative and moderate variable mood" (n = 204), (3) "positive and moderate variable mood" (n = 41), and (4) "negative and highest variable mood" (n = 28). The degree of emotional inertia was virtually identical across the profiles. Conclusions: The real-time monitoring conducted in the present study provides some preliminary indications of different patterns of both average mood and mood variability among MDD patients in treatment in mental health settings. Such varying patterns were not found for emotional inertia.

Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study.

BACKGROUND: Behavioral activation (BA), either as a stand-alone treatment or as part of cognitive behavioral therapy, has been shown to be effective for treating depression. The theoretical underpinnings of BA derive from Lewinsohn et al's theory of depression. The central premise of BA is that having patients engage in more pleasant activities leads to them experiencing more pleasure and elevates their mood, which, in turn, leads to further (behavioral) activation. However, there is a dearth of empirical evidence about the theoretical framework of BA. OBJECTIVE: This study aims to examine the assumed (temporal) associations of the 3 constructs in the theoretical framework of BA. METHODS: Data were collected as part of the "European Comparative Effectiveness Research on Internet-based Depression Treatment versus treatment-as-usual" trial among patients who were randomly assigned to receive blended cognitive behavioral therapy (bCBT). As part of bCBT, patients completed weekly assessments of their level of engagement in pleasant activities, the pleasure they experienced as a result of these activities, and their mood over the course of the treatment using a smartphone-based ecological momentary assessment (EMA) application. Longitudinal cross-lagged and cross-sectional associations of 240 patients were examined using random intercept cross-lagged panel models. RESULTS: The analyses did not reveal any statistically significant cross-lagged coefficients (all P>.05). Statistically significant cross-sectional positive associations between activities, pleasure, and mood levels were identified. Moreover, the levels of engagement in activities, pleasure, and mood slightly increased over the duration of the treatment. In addition, mood seemed to carry over, over time, while both levels of engagement in activities and pleasurable experiences did not. CONCLUSIONS: The results were partially in accordance with the theoretical framework of BA, insofar as the analyses revealed cross-sectional relationships between levels of engagement in activities, pleasurable experiences deriving from these activities, and enhanced mood. However, given that no statistically significant temporal relationships were revealed, no conclusions could be drawn about potential causality. A shorter measurement interval (eg, daily rather than weekly EMA reports) might be more attuned to detecting potential underlying temporal pathways. Future research should use an EMA methodology to further investigate temporal associations, based on theory and how treatments are presented to patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02542891, https://clinicaltrials.gov/ct2/show/NCT02542891; German Clinical Trials Register, DRKS00006866, https://tinyurl.com/ybja3xz7; Netherlands Trials Register, NTR4962, https://www.trialregister.nl/trial/4838; ClinicalTrials.Gov, NCT02389660, https://clinicaltrials.gov/ct2/show/NCT02389660; ClinicalTrials.gov, NCT02361684, https://clinicaltrials.gov/ct2/show/NCT02361684; ClinicalTrials.gov, NCT02449447, https://clinicaltrials.gov/ct2/show/NCT02449447; ClinicalTrials.gov, NCT02410616, https://clinicaltrials.gov/ct2/show/NCT02410616; ISRCTN registry, ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725.

Discovering different profiles in the dynamics of depression based on real-time monitoring of mood: a first exploration.

BACKGROUND: Although depression is typically characterized by a persistent depressed mood, mood dynamics do seem to vary across a depressed population. Heterogeneity of mood variability (magnitude of changes) and emotional inertia (speed at which mood shifts) is seen in clinical practice. However, studies investigating the heterogeneity of these mood dynamics are still scarce. The aim of the present study is to explore different distinctive profiles in real-time monitored mood dynamics among depressed persons. METHODS: After completing baseline measures, mildly-to-moderately depressed persons (n = 37) were prompted to rate their current mood (1-10 scale) on their smartphones, 3 times a day for 7 consecutive days. Latent profile analyses were applied to identify profiles based on average mood, variability of mood and emotional inertia as reported by the participants. RESULTS: Two profiles were identified in this sample. The overwhelming majority of the sample belonged to profile 1 (n = 31). Persons in profile 1 were characterized by a mood just above the cutoff for positive mood (M = 6.27), with smaller mood shifts (lower variability [SD = 1.05]) than those in profile 2 (n = 6), who displayed an overall negative mood (M = 4.72) and larger mood shifts (higher variability [SD = 1.95]) but at similar speed (emotional inertia) (AC = 0.19, AC = 0.26, respectively). CONCLUSIONS: The present study provides preliminary indications for patterns of average mood and mood variability, but not emotional inertia, among mildly-to-moderately depressed persons.

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Experienced Burden of and Adherence to Smartphone-Based Ecological Momentary Assessment in Persons with Affective Disorders.

(1) Background: The use of smartphone-based ecological momentary assessment (EMA) questionnaires in affective disorder research has rapidly increased. Though, a thorough understanding of experienced burden of and adherence to EMA is crucial in determining the usefulness of EMA. (2) Methods: Persons with current affective disorders (n = 100), remitted persons (n = 190), and healthy controls (n = 94) participated in a smartphone-based EMA two-week monitoring period. Our primary outcomes were (momentary) perceived burden of and adherence to EMA. (3) Results: In the whole sample, lower positive and higher negative affect were associated with slightly higher levels of perceived momentary burden (B = -0.23 [95%CI = -0.27-0.19], B = 0.30 [95%CI = 0.24-0.37], respectively). The persons with current affective disorders reported slightly higher levels of experienced momentary burden (Mdn = 1.98 [IQR = 1.28-2.57]), than the remitted persons (Mdn = 1.64 [IQR = 1.11-2.24]) and healthy controls (Mdn = 1.28 [IQR = 1.04-1.92]). Nevertheless, the persons with current affective disorders still showed very high adherence rates (Mdn = 94.3% [IQR = 87.9-97.1]), at rates on a par with the remitted persons (Mdn = 94.3% [IQR = 90.0-97.1]) and healthy controls (Mdn = 94.3% [IQR = 90.0-98.6]). (4) Discussion: Frequent momentary questionnaires of mental well-being are slightly more burdensome to the persons with current affective disorders, but this does not seem to have a negative impact on adherence. Their high rate of adherence to EMA-which was similar to that in remitted persons and healthy controls -suggests that it is feasible to apply (short-duration) EMA.

Attitudes towards pharmacotherapy in late-life bipolar disorder.

BACKGROUND: Lithium remains a first-line treatment for bipolar disorder, but clinicians have considerable concern over potential adverse effects, especially in older adults. Older patients' attitude towards lithium has not been investigated, even though negative attitudes are closely associated with reduced adherence. We examine the attitude towards lithium pharmacotherapy in older adults with bipolar disorder. METHODS: In a cross-sectional study of 78 patients aged >60 years with bipolar disorder, the association between lithium use and attitudes towards psychotropic pharmacotherapy was assessed using the Drug Attitude Inventory (DAI-10), including multivariate analyses. RESULTS: Compared to patients using alternative psychopharmacological treatments (n =30), lithium users (n=48) showed higher self-reported contentedness, subjective somatic health, and social functioning scores. Although 58.7% of lithium users reported severe adverse effects, lithium users had more positive attitudes towards psychotropic pharmacotherapy compared to non-users (DAI-10 mean score 6.0 vs. 3.9, p =0.01), and this effect was independent of potential confounders. CONCLUSIONS: Older bipolar patients using lithium have a more positive attitude towards psychotropic pharmacotherapy, despite high rates of adverse effects. Future longitudinal studies could investigate whether positive medication attitudes lead to improved treatment adherence and reduced bipolar disorder relapse in older lithium users.

Tablet-based support for older adults with severe mood disorders treated in an ambulatory geriatric psychiatry setting: Protocol of a feasibility study of the eCare@Home platform.

INTRODUCTION: Although older adults are just as likely to benefit from e-mental health as their younger counterparts, there are virtually no applications specifically designed to accommodate the needs of older adults with recurrent depression or bipolar disorder. Recurrent mood disorders constitute a large and rising proportion of the global disease in older populations, indicating a need for more e-mental health applications targeting this group. This paper describes the theoretical background and methodology of a study examining the feasibility of a tablet-based self-management platform for older adults with recurrent mood disorders. The eCare@Home platform was designed to 1) improve patients' awareness and knowledge of recurrent mood disorders and their treatment, 2) promote self-management through the use of a simple daily monitoring tool, and 3) facilitate online contact with their clinician through videoconferencing. METHODS: The design involves a single-group four-month pilot study, with measurements at baseline (T0), and at weeks 8 and 16 (T1 and T2). The target group consists of older outpatients (aged 60 or above) who are undergoing treatment for recurrent depressive or bipolar disorder (N = 50), and their clinicians (N = 10). Primary feasibility endpoints will be system acceptability, system usability, and client satisfaction with the platform. In addition, qualitative data from semi-structured interviews in N = 10 patients and N = 5 clinicians will be gathered to provide more insight into user experiences and evaluations of the platform's added value. DISCUSSION: To the best of our knowledge, this is the first study to evaluate the feasibility and acceptability of a tablet-based e-mental health platform for older adults with severe mood disorders. If tablet-based support for this group is shown to be feasible, the intention is to proceed with the design of a large-scale process and outcome evaluation. The strengths and limitations of the methodology used are addressed in this article.Trial Registration: registration is pending.

The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study: design and rationale of a longitudinal naturalistic study of the course of OCD and clinical characteristics of the sample at baseline.

In half of Obsessive Compulsive Disorder (OCD) patients the disorder runs a chronic course despite treatment. The factors determining this unfavourable outcome remain unknown. The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study is a multicentre naturalistic cohort study of the biological, psychological and social determinants of chronicity in a clinical sample. Recruitment of OCD patients took place in mental health organizations. Its design is a six-year longitudinal cohort study among a representative clinical sample of 419 OCD patients. All five measurements within this six-year period involved validated semi-structured interviews and self-report questionnaires which gathered information on the severity of OCD and its co-morbidity as well as information on general wellbeing, quality of life, daily activities, medical consumption and key psychological and social factors. The baseline measurements also include DNA and blood sampling and data on demographic and personality variables. The current paper presents the design and rationale of the study, as well as data on baseline sample characteristics. Demographic characteristics and co-morbidity ratings in the NOCDA sample closely resemble other OCD study samples. Lifetime co-morbid Axis I disorders are present in the majority of OCD patients, with high current and lifetime co-morbidity ratings for affective disorders (23.4% and 63.7%, respectively) and anxiety disorders other than OCD (36% current and 46.5% lifetime).

Effects of Internet-based guided self-help problem-solving therapy for adolescents with depression and anxiety: a randomized controlled trial.

BACKGROUND: Symptoms of depression and anxiety are highly prevalent in adolescence and they are the cause of considerable suffering. Even so, adolescents are not inclined to seek professional help for emotional problems. Internet-based preventive interventions have been suggested as a feasible method of providing appropriate care to adolescents with internalizing symptoms. The objective of this study was to evaluate the effects of preventive Internet-based (guided) self-help problem-solving therapy (PST) for adolescents reporting mild to moderate symptoms of depression and/or anxiety as compared to a waiting list control group (WL). METHODOLOGY/PRINCIPAL FINDINGS: A total of 45 participants were randomized to the 2 conditions. PST consisted of 5 weekly lessons. Participants were supported by e-mail. Self-report measures of depression and anxiety were filled in at baseline and after 3 weeks, 5 weeks, and 4 months. Of the 45 participants, 28 (62.2%) completed questionnaires after 3 weeks, 28 (62.2%) after 5 weeks, and 27 (60%) after 4 months. Hierarchical linear modeling analyses revealed overall improvement over time for both groups on depressive and anxiety symptoms. However, no significant group x time interactions were found. No differences were found between completers and non-completers. CONCLUSIONS/SIGNIFICANCE: Results show that depressive and anxiety symptoms declined in both groups. No support was found, however, for the assumption that Internet-based PST was efficacious in reducing depression and anxiety in comparison to the waiting list control group. This finding could represent lack of power. TRIAL REGISTRATION: Netherlands Trial Register NTR1322.

Randomized controlled trial of primary care physician motivational interviewing versus brief advice to engage adolescents with an Internet-based depression prevention intervention: 6-month outcomes and predictors of improvement.

We believe that primary care physicians could play a key role in engaging youth with a depression prevention intervention. We developed CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral and Interpersonal Training), which is an adolescent Internet-based behavior change model. We conducted a randomized comparison of two approaches in engaging adolescents with the Internet intervention: primary care physician (PCP) motivational interview + CATCH-IT Internet program (MI) vs PCP brief advice + CATCH-IT Internet program (BA). The participants (N = 84) were recruited by screening for risk of depression in 13 primary care practices. We compared depressive disorder outcomes between groups and within groups over 6 months and examined the potential predictors and moderators of outcomes across both study arms. Depressive symptom scores declined from baseline to 6 weeks with these statistically significant reductions sustained at the 6 months follow-up in both groups. No significant interactions with treatment condition were found. However, by 6 months, the MI group demonstrated significantly fewer depressive episodes and reported less hopelessness as compared with the BA group. Hierarchical linear modeling regressions showed higher ratings of ease of use of the Internet program predicting lower depressive symptom levels over 6 months. In conclusion, a primary care/Internet-based intervention model among adolescents demonstrated reductions in depressed mood over 6 months and may result in fewer depressive episodes.

Late-life anxiety disorders: a review.

Anxiety disorders are a major clinical problem in late life; estimated prevalence rates vary from 6% to 10%, and the disease impact is considerable and equal to that of depression. However, anxiety disorders often remain undetected and untreated in older adults. This discrepancy may be accounted for by a combination of patient variables (eg, a lack of help-seeking behavior and long duration of illness) and variables related to current clinical practice (eg, a lack of knowledge regarding late-life anxiety and ageism). Because anxiety disorders usually have an age at onset earlier in life, patients and mental health professionals may be inclined to attribute the anxiety and avoidance symptoms to personality factors instead of a treatable syndrome. Comorbidity with other psychiatric disorders, such as depressive disorder, may complicate the appropriate diagnosis. Identification may be further obscured because the phenomenology of anxiety disorders in older adults tends to differ from the phenomenology in younger adults. Randomized controlled trials have yielded support for the effectiveness of cognitive-behavioral therapy and serotonergic antidepressants. However, both treatments seem hampered by relatively high dropout rates, and the available data are based primarily on a relatively healthy, well-educated, and "young" older population. The dissemination of knowledge regarding late-life anxiety disorders is vital, as evidence-based treatments are available but are still rarely implemented.

The epidemiology of specific phobia and subthreshold fear subtypes in a community-based sample of older adults.

BACKGROUND: Specific phobias have received little attention among older adults. This study is aimed at determining the 12-month prevalence rates of fear subtypes in older adults with a full or subthreshold DSM diagnosis of specific phobia as well as to examine differences among these conditions according to health and health behavior characteristics potentially associated with the severity of anxious symptoms. METHODS: Data came from a representative sample of community-dwelling older adults aged 65 years and older (N = 2784). Diagnoses were established by in-home semi-structured interviews. DSM-IV criteria for specific phobia were slightly modified in line with recommendations for DSM-V. RESULTS: The 12-month prevalence rates of specific phobias and subthreshold fears were, respectively, 2.0 and 8.7%. More than half of the respondents with a specific phobia did not recognize the "excessiveness" of their fears. Situational and natural environment fears were the most frequent subtypes. Compared to respondents with no symptoms of anxiety, older adults with a full- or subthreshold-specific phobia reported more chronic physical health problems, more comorbid depressive disorders and a higher use of benzodiazepines. However, older adults with specific phobia reported more comorbid anxiety disorders than respondents with subthreshold fears. CONCLUSIONS: The present study provides evidence for the fact that subthreshold fears have a high prevalence among older adults. Since several older people with specific phobia do not recognize the "excessiveness" of their fears, it is recommended that DSM-V criteria allow clinicians to rely on their own judgment to assess whether the perceived danger is out of proportion.

Does the therapy manual or the therapist matter most in treatment of obsessive-compulsive disorder? A randomized controlled trial of exposure with response or ritual prevention in 118 patients.

BACKGROUND: The importance of the therapist's education and experience for the successful behavior treatment of obsessive-compulsive disorder (OCD) has not been investigated. Data on the relative effectiveness of self-controlled versus therapist-controlled in vivo exposure with response or ritual prevention (ERP) have yielded conflicting results. The present study compared the effectiveness of 4 different modes of delivery of ERP in a referred sample of OCD patients. METHOD: Of the 146 eligible OCD outpatients, 118 patients enrolled in this randomized controlled trial and were randomly assigned to (1) therapist-controlled ERP performed by experienced behavior therapists; (2) therapist-controlled ERP performed by master's students of clinical psychology; (3) self-controlled ERP performed by experienced behavior therapists; and (4) self-controlled ERP performed by master's students of clinical psychology. This trial was performed from January 1999 to January 2005. RESULTS: Our analyses revealed no significant differences in clinical outcome between any of the different modes of delivery of ERP at posttreatment. The different ERP modes of delivery were associated with significant pretreatment to posttreatment improvement on all measurements, with large effect sizes on the primary outcome measure, the Yale-Brown Obsessive Compulsive Scale. CONCLUSIONS: Our results indicate that clinically inexperienced master's students with no postgraduate training can be as capable as experienced and certified behavior therapists in treating OCD patients, as long as therapists adhere to a standardized treatment manual and adequate training and supervision is provided. In contrast to other studies, we did not find a supposed benefit of therapist-controlled ERP versus self-controlled ERP in patients with OCD. TRIAL REGISTRATION: www.trialregister.nl Identifier: NTR1444.

Psychotherapy for chronic major depression and dysthymia: a meta-analysis.

Although several studies have examined the effects of psychotherapy on chronic depression and dysthymia, no meta-analysis has been conducted to integrate results of these studies. We conducted a meta-analysis of 16 randomized trials examining the effects of psychotherapy on chronic depression and dysthymia. We found that psychotherapy had a small but significant effect (d=0.23) on depression when compared to control groups. Psychotherapy was significantly less effective than pharmacotherapy in direct comparisons (d=-0.31), especially SSRIs, but that this finding was wholly attributable to dysthymic patients (the studies examining dysthymia patients were the same studies that examined SSRIs). Combined treatment was more effective than pharmacotherapy alone (d=0.23) but even more so with respect to psychotherapy alone (d=0.45), although again this difference may have reflected the greater proportion of dysthymic samples in the latter. No significant differences were found in drop-out rates between psychotherapy and the other conditions. We found indications that at least 18 treatment sessions are needed to realize optimal effects of psychotherapy. We conclude that psychotherapy is effective in the treatment of chronic depression and dysthymia but probably not as effective as pharmacotherapy (particularly the SSRIs).

Prevention of depression and anxiety in adolescents: a randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy.

BACKGROUND: Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best. METHODS/DESIGN: This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted. DISCUSSION: This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed. TRIAL REGISTRATION: Netherlands Trial Register NTR1322.

Long-term effectiveness and prediction of treatment outcome in cognitive behavioral therapy and sertraline for late-life anxiety disorders.

BACKGROUND: Although anxiety disorders are prevalent in older adults, randomized controlled trials of treatment effectiveness for late-life anxiety are scarce and have focused primarily on the effectiveness of psychotherapeutic interventions. However, recent findings suggest that in some cases, pharmacological treatment may be more beneficial for late-life anxiety disorders. As yet, there have been no systematic studies investigating prognostic factors for the outcome of cognitive behavioral therapy (CBT) and pharmacotherapy for late-life anxiety. The objective of the present study was to study long-term treatment outcomes and to explore differential predictors for both short-term and long-term treatment outcomes of sertraline and CBT for late-life anxiety disorders. METHODS: Participants of a randomized controlled trial (RCT) comparing sertraline and CBT for the treatment of late-life anxiety were contacted one year after completing their treatment, so that predictors for both short-term and long-term treatment outcome could be established. RESULTS: Sertraline showed a greater reduction of symptoms than CBT on anxiety (Hamilton Anxiety Rating Scale; HARS) and worry (Worry Domain Questionnaire) ratings at one-year follow-up. The strongest predictor for short-term CBT outcome was poor perceived health, explaining 40% of the variance in post-treatment residual gain scores on the HARS. The strongest predictor for long-term CBT outcome was neuroticism, explaining 20% of the variance in residual gain scores at one-year follow-up. Analyses revealed no significant predictors for treatment outcome in sertraline participants. CONCLUSIONS: Our study suggests that long-term use of sertraline might be more beneficial for late-life anxiety than a 15-week CBT program. Poor perceived health and neuroticism are predictive of less improvement after CBT in anxious older adults. Implications of these findings are discussed.