Estimating the prognostic value of cross-sectional network connectivity for treatment response in depression.

BACKGROUND: Tightly connected symptom networks have previously been linked to treatment resistance, but most findings come from small-sample studies comparing single responder v. non-responder networks. We aimed to estimate the association between baseline network connectivity and treatment response in a large sample and benchmark its prognostic value against baseline symptom severity and variance. METHODS: N = 40 518 patients receiving treatment for depression in routine care in England from 2015-2020 were analysed. Cross-sectional networks were constructed using the Patient Health Questionnaire-9 (PHQ-9) for responders and non-responders (N = 20 259 each). To conduct parametric tests investigating the contribution of PHQ-9 sum score mean and variance to connectivity differences, networks were constructed for 160 independent subsamples of responders and non-responders (80 each, n = 250 per sample). RESULTS: The baseline non-responder network was more connected than responders (3.15 v. 2.70, S = 0.44, p < 0.001), but effects were small, requiring n = 750 per group to have 85% power. Parametric analyses revealed baseline network connectivity, PHQ-9 sum score mean, and PHQ-9 sum score variance were correlated (r = 0.20-0.58, all p < 0.001). Both PHQ-9 sum score mean (ß = -1.79, s.e. = 0.07, p < 0.001), and PHQ-9 sum score variance (ß = -1.67, s.e. = 0.09, p < 0.001) had larger effect sizes for predicting response than connectivity (ß = -1.35, s.e. = 0.12, p < 0.001). The association between connectivity and response disappeared when PHQ-9 sum score variance was accounted for (ß = -0.28, s.e. = 0.19, p = 0.14). We replicated these results in patients completing longer treatment (8-12 weeks, N = 22 952) and using anxiety symptom networks (N = 70 620). CONCLUSIONS: The association between baseline network connectivity and treatment response may be largely due to differences in baseline score variance.

The Precision in Psychiatry (PIP) study: Testing an internet-based methodology for accelerating research in treatment prediction and personalisation.

BACKGROUND: Evidence-based treatments for depression exist but not all patients benefit from them. Efforts to develop predictive models that can assist clinicians in allocating treatments are ongoing, but there are major issues with acquiring the volume and breadth of data needed to train these models. We examined the feasibility, tolerability, patient characteristics, and data quality of a novel protocol for internet-based treatment research in psychiatry that may help advance this field. METHODS: A fully internet-based protocol was used to gather repeated observational data from patient cohorts receiving internet-based cognitive behavioural therapy (iCBT) (N = 600) or antidepressant medication treatment (N = 110). At baseline, participants provided > 600 data points of self-report data, spanning socio-demographics, lifestyle, physical health, clinical and other psychological variables and completed 4 cognitive tests. They were followed weekly and completed another detailed clinical and cognitive assessment at week 4. In this paper, we describe our study design, the demographic and clinical characteristics of participants, their treatment adherence, study retention and compliance, the quality of the data gathered, and qualitative feedback from patients on study design and implementation. RESULTS: Participant retention was 92% at week 3 and 84% for the final assessment. The relatively short study duration of 4 weeks was sufficient to reveal early treatment effects; there were significant reductions in 11 transdiagnostic psychiatric symptoms assessed, with the largest improvement seen for depression. Most participants (66%) reported being distracted at some point during the study, 11% failed 1 or more attention checks and 3% consumed an intoxicating substance. Data quality was nonetheless high, with near perfect 4-week test retest reliability for self-reported height (ICC = 0.97). CONCLUSIONS: An internet-based methodology can be used efficiently to gather large amounts of detailed patient data during iCBT and antidepressant treatment. Recruitment was rapid, retention was relatively high and data quality was good. This paper provides a template methodology for future internet-based treatment studies, showing that such an approach facilitates data collection at a scale required for machine learning and other data-intensive methods that hope to deliver algorithmic tools that can aid clinical decision-making in psychiatry.

Facilitating access to iCBT: a randomized controlled trial assessing a translated version of an empirically validated program using a minimally monitored delivery model.

BACKGROUND: Despite its established efficacy, access to internet-delivered CBT (iCBT) remains limited in a number of countries. Translating existing programs and using a minimally monitored model of delivery may facilitate its dissemination across countries. AIMS: This randomized control trial aims to evaluate the efficacy of an iCBT transdiagnostic program translated from English to French and offered in Canada using a minimally monitored delivery model for the treatment of anxiety and depression. METHOD: Sixty-three French speakers recruited in Canada were randomized to iCBT or a waiting-list. A French translation of an established program, the Wellbeing Course, was offered over 8 weeks using a minimally monitored delivery model. Primary outcome measures were the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9), which were obtained pre-treatment, post-treatment and at 3-month follow-up. RESULTS: Mixed-effects models revealed that participants in the treatment group had significantly lower PHQ-9 and GAD-7 scores post-treatment than controls with small between-groups effect sizes (d = 0.34 and 0.37, respectively). Within-group effect sizes on primary outcome measures were larger in the treatment than control group. Clinical recovery rates on the PHQ-9 and GAD-7 were significantly higher among the treatment group (40 and 56%, respectively) than the controls (13 and 16%, respectively). CONCLUSIONS: The provision of a translated iCBT program using a minimally monitored delivery model may improve patients' access to treatment of anxiety and depression across countries. This may be an optimal first step in improving access to iCBT before sufficient resources can be secured to implement a wider range of iCBT services.

Internet-delivered cognitive behaviour therapy for chronic health conditions: a systematic review and meta-analysis.

This systematic review and meta-analysis aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (ICBT) on anxiety and depression among persons with chronic health conditions. A systematic database search was conducted of MEDLINE, CINAHL, PsycInfo, EMBASE, and Cochrane for relevant studies published from 1990 to September 2018. A study was included if the following criteria were met: (1) randomized controlled trial involving an ICBT intervention; (2) participants experienced a chronic health condition; (3) participants ≥ 18 years of age; and (4) effects of ICBT on anxiety and/or depression were reported. The Cochrane Risk of Bias tool was used to assess the risk of bias on the included studies. Pooled analysis was conducted on the primary and condition specific secondary outcomes. Twenty-five studies met inclusion criteria and investigated the following chronic health conditions: tinnitus (n = 6), fibromyalgia (n = 3), pain (n = 7), rheumatoid arthritis (n = 3), cardiovascular disease (n = 2), diabetes (n = 1), cancer (n = 1), heterogeneous chronic disease population (n = 1), and spinal cord injury (n = 1). Pooled analysis demonstrated small effects of ICBT in improving anxiety and depression. Moderate effects of therapist-guided approach were seen for depression and anxiety outcomes; while, self-guided approaches resulted in small effects for depression and moderate effects in anxiety outcomes. ICBT shows promise as an alternative to traditional face-to-face interventions among persons with chronic health conditions. Future research on long-term effects of ICBT for individuals with chronic health conditions is needed.Trial Registration PROSPERO registration number: CRD42018087292.

Healthcare use in patients with cardiovascular disease and depressive symptoms - The impact of a nurse-led internet-delivered cognitive behavioural therapy program. A secondary analysis of a RCT.

Background: Depressive symptoms in patients with cardiovascular disease (CVD) can lead to increased healthcare use. In a randomized controlled trial (ClinicalTrials.gov, NCT02778074), we reported that a 9-week internet-delivered cognitive behavioural therapy (iCBT) program (n = 72) compared to an online discussion forum (ODF) (n = 72) had moderate to large effect on depression in CVD outpatients. In this secondary analysis, we aimed to describe and compare the effect of iCBT compared to ODF regarding healthcare use and to identify factors impacting healthcare use in these groups. Methods: Data on healthcare use were retrieved from care data registries in five hospitals in Southeastern Sweden. Results: The year prior to intervention, the iCBT group had a mean of 31 outpatient clinic/primary care contacts per patient compared with 21 contacts the year after. The corresponding numbers for the ODF group were 37 and 25. The decrease was 32 % in both groups and did not differ significantly (p = 0.261 and p = 0.354) between the groups. Regarding hospital admissions, the iCBT group had 0.8 admissions per patient the year before and 0.6 the year after the intervention, a decrease by 25 %, whereas the ODF group had 1.1 and 0.6 admissions respectively, a decrease by 45 %. The difference was not statistically significant (p = 0.270 and p = 0.883) between the groups. Improvement in depressive symptoms post intervention were significantly (Beta = 0.459, p = 0.047) associated with a decrease in number of outpatient contacts in the iCBT group. In the ODF group, better mental health-related quality of life post intervention was significantly (Beta = -0.429, p = 0.045) associated with a decrease in number of hospital admissions. Conclusion: Reduced depressive symptom scores following intervention were associated with lower outpatient service use, but iCBT was not superior compared to ODF. This implicates that reducing depression in CVD patients, regardless of the type of internet-delivered intervention used, is important since it may reduce healthcare use in these patients.

Comparison of outcomes across low-intensity psychological interventions for depression and anxiety within a stepped-care setting: A naturalistic cohort study using propensity score modelling.

Low-intensity interventions for common mental disorders (CMD) address issues such as clinician shortages and barriers to accessing care. However, there is a lack of research into their comparative effectiveness in routine care. We aimed to compare treatment effects of three such interventions, utilizing four years' worth of routine clinical data. Users completing a course of guided self-help bibliotherapy (GSH), internet-delivered cognitive behavioural therapy (iCBT) or psychoeducational group therapy (PGT) from a stepped-care service within the NHS in England were included. Propensity score models (stratification and weighting) were used to control for allocation bias and determine average treatment effect (ATE) between the interventions. 21,215 users comprised the study sample (GSH = 12,896, iCBT = 6862, PGT = 1457). Adherence-to-treatment rates were higher in iCBT. All interventions showed significant improvements in depression (PHQ-9), anxiety (GAD-7) and functioning (WSAS) scores, with largest effect sizes for iCBT. Both propensity score models showed a significant ATE in favour of iCBT versus GSH and PGT, and in favour of GSH versus PGT. Discernible differences in effectiveness were seen for iCBT in comparison with GSH and PGT. Given variance in delivery mode and human resources between different low-intensity interventions, building on these findings would be valuable for future service provision and policy decision making.

Transdiagnostic internet-delivered cognitive behaviour therapy: Feasibility of a motivational interviewing resource.

Background: Despite growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (ICBT), engagement and treatment outcomes are lower for some clients. Online motivational interviewing (MI) has been investigated prior to offering ICBT to facilitate engagement and outcomes, but only appears to improve engagement. Purpose: This feasibility study investigated the potential use of a brief MI resource offered during ICBT rather than before, by examining: (1) use of the resource; (2) client and treatment variables associated with use; (3) whether use of the resource was associated with improved engagement and outcomes; and (4) how those who used the resource evaluated it. Method: This study used data collected from 763 clients enrolled in an ICBT course. Symptoms related to depression, anxiety and disability were assessed at pre- and post-treatment. The website tracked treatment engagement. Clients completed an MI resource evaluation measure at post-treatment. Results: Approximately 15% of clients used the resource. Clients who were older, had higher education, scored in the clinical range on depression, and scored lower on anxiety at pre-treatment were more likely to use the resource. Those who reported using the resource had higher engagement (i.e., more lessons and messages) in ICBT, but lower improvement in disability post-treatment. Positive feedback on the MI resource outweighed negative feedback, with 94 % of clients identifying a positive aspect of the resource and 66 % of clients reporting making changes in response to the resource. Overall, the MI resource appears to be used by and perceived as beneficial by a small portion of clients who complete ICBT. The study provides insight into use of the resource and directions for future research related to MI and ICBT.

Internet-delivered cognitive behavioural therapy for symptoms of PTSD among public safety personnel: Initial outcomes of an open cohort preference trial of transdiagnostic and disorder-specific therapy.

Public safety personnel (PSP) face high rates of mental health problems and many barriers to care. Initial outcomes of transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) tailored for PSP are promising, but prior research has not evaluated outcomes of PTSD-specific ICBT among PSP or PSP's preferences for transdiagnostic or PTSD-specific ICBT. The current paper presents the initial outcomes (N = 150) of a mixed-methods observational study designed to (a) investigate preferences for transdiagnostic or PTSD-specific ICBT among PSP with elevated symptoms of PTSD and/or a primary concern with PTSD symptoms and (b) explore potential differences in client engagement, satisfaction, and symptom changes between the two forms of ICBT. PSP completed questionnaires before and after their preferred ICBT program. Mixed-methods analyses included generalized estimating equations, descriptive statistics, and inductive conventional qualitative content analysis. More clients (n = 85; 57 %) selected transdiagnostic ICBT than PTSD-specific ICBT (n = 65; 43 %), but the difference in the number of clients who selected each course was not statistically significant. Clients in both ICBT programs reported similar and favorable treatment satisfaction (e.g., 98 % would recommend the course to a friend), treatment engagement (i.e., 69 % accessed at least four of the five lessons), and pre-post improvement in symptoms (e.g., Hedges' g = 0.81 for reduction in PTSD symptom). Transdiagnostic ICBT resulted in greater reductions in symptoms of panic disorder than PTSD-specific ICBT. Qualitative analyses showed similarities across the ICBT programs in client feedback. The current study provides further evidence supporting the use and outcomes of ICBT for PSP in both transdiagnostic and disorder-specific formats. Implications for the literatures on PSP mental health and ICBT, as well as practical recommendations, are discussed.

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.

Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression.

Major Depressive Disorder (MDD) is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT) is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT) can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT) included participants meeting diagnostic criteria for MDD (n = 270) being randomised to either: iCBT (n = 61), a CBT self-help book (bCBT) (n = 77), a meditation self-help book (bMED) (n = 64) or wait-list control (WLC) (n = 68). The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9) at 12-weeks (post-treatment). All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88-1.69), which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09-1.04). Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

A feasibility open trial of internet-delivered cognitive-behavioural therapy (iCBT) among consumers of a non-governmental mental health organisation with anxiety.

Background. To date the efficacy and acceptability of internet-delivered cognitive behavioural treatments (iCBT) has been examined in clinical trials and specialist facilities. The present study reports the acceptability, feasibility and preliminary efficacy of an established iCBT treatment course (the Wellbeing Course) administered by a not-for-profit non-governmental organisation, the Mental Health Association (MHA) of New South Wales, to consumers with symptoms of anxiety. Methods. Ten individuals who contacted the MHA's telephone support line or visited the MHA's website and reported at least mild symptoms of anxiety (GAD-7 total scores ≥5) were admitted to the study. Participants were provided access to the Wellbeing Course, which comprises five online lessons and homework assignments, and brief weekly support from an MHA staff member via telephone and email. The MHA staff member was an experienced mental health professional and received minimal training in administering the intervention. Results. All 10 participants completed the course within the 8 weeks. Post-treatment and two month follow-up questionnaires were completed by all participants. Mean within-group effect sizes (Cohen's d) for the Generalized Anxiety Disorder 7 Item (GAD-7) and Patient Health Questionnaire 9 Item (PHQ-9) were large (i.e., > .80) and consistent with previous controlled research. The Course was also rated as highly acceptable with all 10 participants reporting it was worth their time and they would recommend it to a friend. Conclusions. These results provide support for the potential clinical utility of iCBT interventions and the acceptability and feasibility of employing non-governmental mental health organisations to deliver these treatments. However, further research is needed to examine the clinical efficacy and cost-effectiveness of delivering iCBT via such organisations.

Psychological and interpersonal dimensions of sexual function and dysfunction.

INTRODUCTION: Sex therapy techniques comprise behavioural and cognitive as well as psychodynamic and educational interventions, like reading ('bibliotherapy'), videotapes and illustrations of anatomical models. Contemporary approaches focus on desire, pleasure and satisfaction. DISCUSSION: It is important to assess medical and biological factors involved in the genesis of sexual dysfunctions. Sex therapy techniques were developed by Masters and Johnson, and their premise was to eliminate 'performance anxiety' by emphasising the undemanding nature of the sexual relation. New methods were introduced, like Internet-administered techniques, and 'mindfulness therapy', and they proved to be effective. CONCLUSIONS: Psychological treatments have some relieving effects on sexual dysfunction, but for studies of the outcomes it is difficult to meet the requirements of evidence-based medicine.