Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Measuring working alliance and technical alliance from the perspective of healthcare professionals working with people with mild intellectual disabilities: adaptation, factor structure and reliability.

BACKGROUND: The establishment of a valuable and meaningful working alliance between people with mild intellectual disabilities (IDs) and healthcare professionals is critically important for improving both the quality of life and impact of therapy for people with mild IDs. Measuring the working alliance as a treatment or support component is therefore of utmost relevance. In light of the increased use of eHealth tools, it is also essential to measure the alliance using these tools, which is referred to as technical alliance. There was a lack of validation of these two measurements for healthcare professionals working with people with mild IDs, which this study sought to address. METHOD: Both the validated Working Alliance Inventory - Short Form - MID (WAI-SF-MID) and Technical Alliance Inventory - Short Form - MID (TAI-SF-MID) for general patient populations were adapted for healthcare professionals working with people with mild IDs. A two-step approach was conducted to systematically adapt both measurements with an expert group of healthcare professionals. Confirmatory factor analysis was conducted to test a three-factor structure for both the WAI-SF-MID (N = 199) and the TAI-SF-MID (N = 139), and internal consistency was determined for both scales. RESULTS: An acceptable-to-good model fit was found for both the WAI-SF-MID and the TAI-SF-MID; confirmatory factor analysis confirmed a three-factor model for both measurements. Cronbach's alpha and McDonald's omega were excellent for both total scales (≥0.90) and acceptable to good for sub-scales of both versions. CONCLUSION: Both the WAI-SF-MID and the TAI-SF-MID are promising measurements for determining healthcare professionals' perspective on the (digital) working alliance with people with mild IDs.

[Online schema therapy: a cross-sectional survey among Dutch therapists]. / Schematherapie via beeldbellen; crosssectioneel onderzoek onder therapeuten.

BACKGROUND: Long waiting lists exist for the treatment of personality disorders, which can be shortened by using videoconference treatment. During the COVID-19 pandemic, by necessity, videoconferencing was used to provide schema therapy, a specific treatment for personality disorders. AIM: To investigate therapist experience of schema therapy via videoconferencing during the pandemic. METHOD: In an observational cross-sectional study, 83 schema therapists completed a questionnaire about the period prior to, and during the COVID-19 pandemic. We investigated their experience, use of, and attitude toward videoconferencing, as well as the extent to which the effectiveness of videoconferencing and face to face (F2F) schema therapy for personality disorders was found to be comparable. RESULTS: Schema therapists rated their experience with videoconferencing therapy for personality disorders during the COVID-19 pandemic positively, its use increased during this period, and therapists’ attitudes became more positive. However, the majority found videoconferencing therapy less effective than F2F treatment. Almost half of the therapists used shorter sessions or adapted exercises during videoconferencing therapy. CONCLUSION: Although therapists were increasingly positive about video conferencing therapy, they believed that F2F treatment is more effective. Randomized efficacy studies of videoconferencing therapy compared to F2F therapy are needed, also examining patients’ experiences with both forms.

Re-evaluating randomized clinical trials of psychological interventions: Impact of response shift on the interpretation of trial results.

BACKGROUND: Effectiveness of psychological treatment is often assessed using patient-reported health evaluations. However, comparison of such scores over time can be hampered due to a change in the meaning of self-evaluations, called 'response shift'. Insight into the occurrence of response shift seems especially relevant in the context of psychological interventions, as they often purposefully intend to change patients' frames of reference. AIMS: The overall aim is to gain insight into the general relevance of response shift for psychological health intervention research. Specifically, the aim is to re-analyse data of published randomized controlled trials (RCTs) investigating the effectiveness of psychological interventions targeting different health aspects, to assess (1) the occurrence of response shift, (2) the impact of response shift on interpretation of treatment effectiveness, and (3) the predictive role of clinical and background variables for detected response shift. METHOD: We re-analysed data from RCTs on guided internet delivered cognitive behavioural treatment (CBT) for insomnia in the general population with and without elevated depressive symptoms, an RCT on meaning-centred group psychotherapy targeting personal meaning for cancer survivors, and an RCT on internet-based CBT treatment for persons with diabetes with elevated depressive symptoms. Structural equation modelling was used to test the three objectives. RESULTS: We found indications of response shift in the intervention groups of all analysed datasets. However, results were mixed, as response shift was also indicated in some of the control groups, albeit to a lesser extent or in opposite direction. Overall, the detected response shifts only marginally impacted trial results. Relations with selected clinical and background variables helped the interpretation of detected effects and their possible mechanisms. CONCLUSION: This study showed that response shift effects can occur as a result of psychological health interventions. Response shift did not influence the overall interpretation of trial results, but provide insight into differential treatment effectiveness for specific symptoms and/or domains that can be clinically meaningful.

The effect of e-mental health interventions on academic performance in university and college students: A meta-analysis of randomized controlled trials.

BACKGROUND: Mental health symptoms are common among college and university students and these can affect their academic performance. E-mental health interventions have proven effective in addressing mental health complaints but their effect on academic performance has not been synthesized yet. OBJECTIVES: To synthesize the evidence from randomized controlled trials for the effectiveness of e-mental health interventions on academic performance in college and university students compared to inactive controls. DATA SOURCES AND ELIGIBILITY CRITERIA: We searched six databases (PubMed, Cochrane library, CINAHL, ERIC, PsycINFO, Web of Science) during the period January 2000 until September 2019 for randomized controlled trials that reported on e-mental health interventions (guided or unguided) for college and university students and measured academic performance (e.g. grade point average). STUDY APPRAISAL AND SYNTHESIS METHODS: Study and participant characteristics and the academic performance measures at post-intervention were extracted. The latter were pooled and Hedges' g was calculated as the effect size. Heterogeneity and publication bias were investigated. RESULTS: Six studies containing 2428 participants were included in the meta-analysis. These focussed on either mood and anxiety or alcohol and tobacco use. The pooling of data resulted in a small but non-significant effect of g = 0.26 (95% CI, -0.00, 0.52; p = .05) on academic performance, favouring e-mental health interventions over inactive controls. Interventions had positive effects on depression (g = -0.24) and anxiety (g = -0.2). Heterogeneity was high. DISCUSSION: Despite the small and non-significant effect, our meta-analysis points to a promising direction for the effectiveness of e-mental health interventions on academic performance. Yet, these results must be interpreted with caution, as heterogeneity was high and few studies on the effectiveness of e-mental health interventions for students reported academic performance measures.

Towards a European health research and innovation cloud (HRIC).

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

Six-year healthcare trajectories of adults with anxiety and depressive disorders: Determinants of transition to specialised mental healthcare.

BACKGROUND: To investigate potential facilitators and barriers for patients receiving specialised mental healthcare using a longitudinal design. METHODS: Longitudinal data on 701 adult participants with a depressive and/or anxiety disorder were derived from the Netherlands Study of Depression and Anxiety (NESDA). Demographic, clinical and treatment determinants at baseline were assessed with self-report questionnaires and the Composite International Diagnostic Interview (CIDI 2.1). Transition to specialised mental healthcare was assessed at one, two, four, and six-year follow-up with a self-report resource use questionnaire (TiC-P). RESULTS: 28.3% of patients with a depressive and/or anxiety disorder transitioned from receiving no care or primary mental healthcare to specialised mental health services during six-year follow-up. The multivariate Cox regression model identified suicidal ideation, younger age, higher education level, openness to experience, pharmacological treatment, prior treatment in primary mental healthcare and perceived unmet need for help as determinants of transition, explaining 8-18% of variance. LIMITATIONS: This study focused on baseline determinants of future transition to specialised mental healthcare. Recovery and remittance of depression and anxiety in relation to transition were not studied. CONCLUSIONS: Not all key clinical guideline characteristics such as severity of symptoms and comorbidity were predictive of a transition to specialised mental healthcare, while non-clinical factors, such as age and perceived unmet need for help, did influence the process.

The 6-month effectiveness of Internet-based guided self-help for depression in adults with Type 1 and 2 diabetes mellitus.

AIM: The aim of this research is to examine the 6-month effects of an Internet-based guided self-help intervention for comorbid depressive symptoms in people with diabetes. METHODS: Participants (n = 260) with Type 1 or 2 diabetes and elevated depressive symptoms [Center for Epidemiological Studies Depression Scale (CES-D) ≥ 23] were randomly assigned to a guided Internet-based self-help intervention or a control condition (treatment as usual + online psychoeducation about depression). The primary outcome was a change in depressive symptom severity (CES-D) from baseline to 6-month follow-up. The secondary outcomes included numbers of people achieving treatment response (reliable change of depressive symptoms) and remission (CES-D ≤ 16), as well as the effects on glycaemic control, diabetes-related emotional distress and diabetes acceptance. Repeated measures analysis of variance examined between-group differences using intent-to-treat principles. RESULTS: Both conditions showed improvements in depression severity: intervention condition, d = 1.48 [95% confidence interval (95% CI): 1.21 to 1.76]; control condition d = 0.55 (95% CI: 0.30 to 0.80). Changes were significantly greater in the intervention condition with a large between-group effect size (d = 0.83, 95% CI: 0.57 to 1.08). Accordingly, effects on response [relative risk (RR) = 2.60 (95% CI: 2.01 to 3.36), P < 0.001] and remission [RR = 3.36 (95% CI: 2.98 to 5.44), P < 0.001] were in favour of the intervention group, as were differences in change in diabetes emotional distress (d = 0.50, 95% CI: 0.04 to 0.54), and physical and mental functioning [Short Form Health Survey (SF-12) Physical d = 0.27 (95% CI: 0.01 to 0.51) and SF-12 Mental d = 0.68 (95% CI: 0.11 to 0.40)]. The intervention group was not superior with regard to glycaemic control, diabetes self-management and diabetes acceptance. CONCLUSIONS: The trial indicates that Internet-based guided self-help treatments for depression in people with diabetes can have sustained effects on depressive symptoms, well-being and emotional distress associated with diabetes.

Does Internet-based guided-self-help for depression cause harm? An individual participant data meta-analysis on deterioration rates and its moderators in randomized controlled trials.

BACKGROUND: Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach. METHOD: Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data. RESULTS: A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29-0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit-risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration. CONCLUSIONS: Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.

E-care 4 caregivers - an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial.

BACKGROUND: Nonprofessional caregivers are highly important in the everyday life of patients with depression. Yet, they may experience increased levels of burden, stress, depression, and anxiety. Therefore, there is a need for interventions that relieve symptoms and are accessible and time-efficient. This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2) the initial effects of E-care 4 caregivers on psychological distress, subjective burden, symptoms of anxiety and depression, and quality of life. METHODS/DESIGN: The study is a randomized controlled trial in which we are comparing the E-care 4 caregivers online intervention with a wait list control group. Eighty-four nonprofessional caregivers of patients with depression aged 18 years or older are being recruited from among the general population. Feasibility is determined by semistructured telephone interviews evaluating the subjects' satisfaction with the intervention and by using a questionnaire on the user-friendliness of the system. The primary outcome measure used to examine the initial effects of the intervention is psychological distress. Secondary outcome measures are subjective burden, symptoms of anxiety and depression, level of mastery, and quality of life. Assessments will be done at baseline and 6 weeks later. Statistical analysis of the effects of the intervention will be carried out on the basis of the intention-to-treat principle. DISCUSSION: E-care 4 caregivers could potentially benefit nonprofessional caregivers, as well as patients and professionals indirectly. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR5268 . Registered on 30 June 2015.

Effectiveness of blended depression treatment for adults in specialised mental healthcare: study protocol for a randomised controlled trial.

BACKGROUND: Internet-based interventions are seen as an important potential strategy to improve accessibility and affordability of high quality treatments in mental healthcare. A growing number of studies have demonstrated the clinical efficacy of internet-based treatment for mood disorders, but scientific evidence for the application in routine specialised mental healthcare settings is limited. Also, little is known about the clinical and health-economic benefits of blended treatment, where online interventions are integrated with face-to-face treatment of depression in one treatment protocol. The primary aim of this study is to investigate the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (bCBT) for depression, as compared to treatment as usual (TAU) in specialised routine mental healthcare in the Netherlands. This trial is part of the E-COMPARED project which has a broader perspective, focussing on primary and specialised care in eight European countries. METHODS/DESIGN: The study is a randomised controlled non-inferiority trial with two parallel conditions: bCBT and TAU. The blended treatment combines individual face-to-face CBT with CBT delivered through an Internet-based treatment platform (Moodbuster). This platform includes a mobile phone application, used for ecological momentary assessments, automated feedback and motivational messages. Weekly alternating face-to-face (10) and online (9) sessions will be delivered over a period of 19-20 weeks. TAU is defined as the routine care that subjects receive when they are diagnosed with depression in specialised mental healthcare. Adult patients ≥ 18 years old meeting DSM-IV diagnostic criteria for major depressive disorder will be recruited within participating outpatient specialised mental healthcare clinics in the Netherlands. Measurements will be taken at baseline and at 3, 6 and 12 months follow-up. The primary outcome will be depressive symptoms, measured with the PHQ-9 and QIDS. Secondary outcomes include health-related quality of life, mastery, treatment preference, working alliance, system usability, treatment satisfaction and possible negative side-effects. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect healthcare costs. DISCUSSION: The results of this study will provide insight into the health and economical outcomes of blended treatment for depression and give an indication of the value of implementing blended treatment in specialised clinical settings. TRIAL REGISTRATION: Netherlands Trial Register NTR4962 . Registered 05-01-2015.

Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis.

BACKGROUND: It is well known that web-based interventions can be effective treatments for depression. However, dropout rates in web-based interventions are typically high, especially in self-guided web-based interventions. Rigorous empirical evidence regarding factors influencing dropout in self-guided web-based interventions is lacking due to small study sample sizes. In this paper we examined predictors of dropout in an individual patient data meta-analysis to gain a better understanding of who may benefit from these interventions. METHOD: A comprehensive literature search for all randomized controlled trials (RCTs) of psychotherapy for adults with depression from 2006 to January 2013 was conducted. Next, we approached authors to collect the primary data of the selected studies. Predictors of dropout, such as socio-demographic, clinical, and intervention characteristics were examined. RESULTS: Data from 2705 participants across ten RCTs of self-guided web-based interventions for depression were analysed. The multivariate analysis indicated that male gender [relative risk (RR) 1.08], lower educational level (primary education, RR 1.26) and co-morbid anxiety symptoms (RR 1.18) significantly increased the risk of dropping out, while for every additional 4 years of age, the risk of dropping out significantly decreased (RR 0.94). CONCLUSIONS: Dropout can be predicted by several variables and is not randomly distributed. This knowledge may inform tailoring of online self-help interventions to prevent dropout in identified groups at risk.

One-year follow-up results of unsupported online computerized cognitive behavioural therapy for depression in primary care: A randomized trial.

OBJECTIVE: To report the one-year follow-up results of computerized cognitive behavioural therapy (CCBT), offered online without professional support, for depression compared with usual GP care and a combination of both treatments. To explore potential relapse prevention effects of CCBT. METHODS: 303 depressed patients were randomly allocated to (a) unsupported online CCBT (b) treatment as usual (TAU), or (c) CCBT and TAU combined. We had a 12-month follow-up period. Primary outcome measure was the Beck Depression Inventory II. Self-reported health care use was also measured. KEY FINDINGS: At 12 months, no statistically significant differences between the three interventions are found in the intention-to-treat population for depressive severity, reliable improvement, remission, and relapse. In the first quarter, differences in health care consumption between the three interventions are significant (i.e. less GP contacts, less antidepressant medication, and less specialist mental health care in the CCBT group), but these differences disappear over time. CONCLUSIONS: Unsupported online CCBT is not superior to TAU by a GP for depression. With equal effects, CCBT alone leads to less health care consumption than TAU and CCBT&TAU. Overall effects are modest in all interventions, which can be explained by the finding that the use of health care services decreases despite the lack of substantial improvements.

Economic evaluation of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial.

BACKGROUND: Evidence about the cost-effectiveness and cost utility of computerised cognitive-behavioural therapy (CCBT) is still limited. Recently, we compared the clinical effectiveness of unsupported, online CCBT with treatment as usual (TAU) and a combination of CCBT and TAU (CCBT plus TAU) for depression. The study is registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236). AIMS: To assess the cost-effectiveness of CCBT compared with TAU and CCBT plus TAU. METHOD: Costs, depression severity and quality of life were measured for 12 months. Cost-effectiveness and cost-utility analyses were performed from a societal perspective. Uncertainty was dealt with by bootstrap replications and sensitivity analyses. RESULTS: Costs were lowest for the CCBT group. There are no significant group differences in effectiveness or quality of life. Cost-utility and cost-effectiveness analyses tend to be in favour of CCBT. CONCLUSIONS: On balance, CCBT constitutes the most efficient treatment strategy, although all treatments showed low adherence rates and modest improvements in depression and quality of life.

Clinical effectiveness of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial.

BACKGROUND: Computerised cognitive-behavioural therapy (CCBT) might offer a solution to the current undertreatment of depression. AIMS: To determine the clinical effectiveness of online, unsupported CCBT for depression in primary care. METHOD: Three hundred and three people with depression were randomly allocated to one of three groups: Colour Your Life; treatment as usual (TAU) by a general practitioner; or Colour Your Life and TAU combined. Colour Your Life is an online, multimedia, interactive CCBT programme. No assistance was offered. We had a 6-month follow-up period. RESULTS: No significant differences in outcome between the three interventions were found in the intention-to-treat and per protocol analyses. CONCLUSIONS: Online, unsupported CCBT did not outperform usual care, and the combination of both did not have additional effects. Decrease in depressive symptoms in people with moderate to severe depression was moderate in all three interventions. Online CCBT without support is not beneficial for all individuals with depression.

One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years.

BACKGROUND: Internet-based cognitive behaviour therapy (CBT) is a promising new approach for the treatment of depressive symptoms. The current study had two aims: (1) to determine whether, after 1 year, an internet-based CBT intervention was more effective than a waiting-list control group; and (2) to determine whether the effect of the internet-based CBT differed from the group CBT intervention, 1 year after the start of treatment. METHOD: A total of 191 women and 110 men (mean age=55 years, s.d.=4.6) with subthreshold depression were randomized into internet-based treatment, group CBT (Lewinsohn's Coping with Depression Course), or a waiting-list control condition. The main outcome measure was treatment response after 1 year, defined as the difference in pretreatment and follow-up scores on the Beck Depression Inventory (BDI). Missing data were imputed using the multiple imputation procedure of data augmentation. Analyses were performed using multiple imputation inference. RESULTS: In the waiting-list control group, we found a pretreatment to follow-up improvement effect size of 0.69, which was 0.62 in the group CBT condition and 1.22 with the internet-based treatment condition. Simple contrasts showed a significant difference between the waiting-list condition and internet-based treatment (p=0.03) and no difference between both treatment conditions (p=0.08). CONCLUSIONS: People aged over 50 years with subthreshold depression can still benefit from internet-based CBT 1 year after the start of treatment.