iCBT Intervention Research Articles

Reach, uptake, and psychological outcomes of two publicly funded internet-based cognitive behavioural therapy programs in Ontario, Canada: an observational study

BackgroundAccess to traditional mental health services in Canada remains limited, prompting exploration into digital alternatives. The Government of Ontario initiated access to two internet-based cognitive behavioral therapy (iCBT) programs, LifeWorks AbilitiCBT and MindBeacon TAiCBT, for adults with mental health issues.MethodsAn uncontrolled observational study utilizing secondary retrospective program data was conducted to evaluate the reach, uptake, and psychological symptom changes among participants engaging with either iCBT program.ResultsBetween May 2020 and September 2021, 56,769 individuals enrolled in LifeWorks AbilitiCBT, and 73,356 in MindBeacon TAiCBT. However, substantial exclusions were made: 56% of LifeWorks participants and 68% of MindBeacon participants were ineligible or failed to initiate treatment. Consequently, 25,154 LifeWorks participants and 23,795 MindBeacon participants were included in the analysis. Of these, 22% of LifeWorks and 26% of MindBeacon participants completed over 75% of iCBT treatment. On average, LifeWorks participants received 13 ± SD 7.1 therapist messages and sent 5 ± SD 10.3 messages, while MindBeacon participants received 25 ± SD 20.7 therapist messages and sent 13 ± SD 16.4 messages. LifeWorks included synchronous therapist contact averaging 1.4 ± SD 1.9 h per participant, while MindBeacon was purely asynchronous. Baseline severity of anxiety (37%) and depression symptoms (22%) was higher for LifeWorks participants compared to MindBeacon participants (24% and 10%, respectively). Clinically significant changes in anxiety and depression scores were observed: 22% of LifeWorks and 31% of MindBeacon participants exhibited reliable recovery in PHQ-9 scores, while 26% of LifeWorks and 25% of MindBeacon participants demonstrated reliable recovery in GAD-7 scores.ConclusionIn conclusion, iCBT programs show promise for engaged participants with varying levels of severity in anxiety and depression symptoms. Future iterations of iCBT should consider adopting a broad entry criterion to iCBT programming to increase accessibility, especially for those with severe symptoms, alongside integrated intake care pathways, and potential payment structure adjustments for iCBT service providers. Taken all together, these factors could temper high dropout rates post-intake assessment. This evaluation underscores the potential and value of digital mental health interventions for individuals with mild to severe anxiety or depression symptoms, emphasizing the importance of addressing participant dropout.

A digital iCBT intervention for social anxiety disorder in Quebec and Ontario: protocol for a multi-phase effectiveness-implementation study

BackgroundSocial anxiety disorder (SAD) is one of the most prevalent anxiety disorders in Canada. Viable therapy options for the treatment of SAD include CBT being delivered virtually. In Australia, an innovative internet-delivered cognitive-behavioral therapy (iCBT) program for social anxiety has been developed, implemented, and demonstrated as effective. To make available high-quality and real-time evidence in response to the crucial need to access psychological services to meet population mental health needs, we propose to conduct a Canadian adaptation of the iCBT Shyness Program and to examine the program’s effectiveness, and implementation in two Canadian provinces (Quebec and Ontario).MethodsThe overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial. Prior to implementing the iCBT Shyness Program, it will undergo an initial adaptation to the Canadian context and focus groups will be conducted with key actor groups to discuss the adaptations to the graphics, narration of the lessons, and this to better reflect varying socio-cultural context among Canadian French- and English-speaking populations. We will evaluate the effectiveness of the program in three parallel pathways reflecting real-world pathways: (1) self-refer to the intervention; (2) recommended by a health professional without guidance; and (3) recommended by a health professional, with low-intensity guidance. Data collection will be carried out at baseline, at the beginning of each lesson, 12-week and 6-month follow-up. Outcomes measured will include anxiety and depressive symptoms, psychological distress, disability, as well as health service utilization and satisfaction. Semi-structured interviews will then be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program.DiscussionThis study will provide evidence on the effectiveness, barriers and facilitating factors to implementing a low-intensity iCBT in the Canadian context for SAD, which will bridge an important care gap for undeserved populations in Canada with SAD. Findings will inform the eventual scaling up of the program in community-based primary care across Canada. This would improve equity of the health care system by helping a large number of Canadians to timely access to mental health services.Trial registrationclinicaltrials.gov NCT06403995. Prospectively registered on 05/03/2024.

Efficacy of an internet-based guided trauma-focused intervention in reducing ICD-11 posttraumatic stress disorder symptoms: study protocol of a randomized controlled trial

BackgroundPosttraumatic stress disorder (PTSD) is a common mental disorder. However, many cases of PTSD remain untreated because of limited healthcare resources and other treatment-seeking barriers. Effective internet-based interventions could help to improve access to PTSD treatments. Therefore, the main objective of the planned randomized controlled trial is to evaluate the efficacy of the Lithuanian version of the guided internet-based self-help programme (Spring) in reducing ICD-11 PTSD symptoms.MethodsThe planned sample size is 50 participants exposed to different traumatic experiences. Participants eligible for the study will be randomized into two study groups: the immediate treatment group and the delayed treatment control group. Both groups will receive guided trauma-focused ICBT intervention, but the delayed treatment group will receive access to the programme five months after randomization. The International Trauma Interview (ITI) will be used for the assessment of ICD-11 PTSD symptoms at pre-treatment, post-treatment, and at a 3-month follow-up. Changes in disturbances in self-organization, depression and anxiety levels, as well as posttraumatic cognitions and trauma-related shame, will also be evaluated. In addition, associations between changes in symptoms of PTSD and readiness for treatment, treatment expectations and working alliance will be explored. Changes in treatment outcomes will be evaluated using multiple Latent Change Models.DiscussionThis study is expected to contribute to valuable knowledge on the efficacy of internet-based interventions for posttraumatic stress disorder.Trial registrationClinicalTrials.gov NCT06475716. Registered on 25 June 2024.

Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study.

Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences arise from this psychiatric condition. Prompt treatment with an appropriate method of delivery is required to achieve optimal outcomes in GD patients. This protocol paper outlines a study to determine the effectiveness, acceptability, and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD in Indonesia. This non-randomized pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post- treatment completion (week 10), and 6 weeks post-treatment (week 16). The outcomes measured will be the change in gambling symptoms, gambling urges, cognitive distortions, readiness to change, emotional problems, and quality of life of the participants. The feasibility of iCBT for GD patients in Indonesia will be assessed by this study. The study's results will give an indication of the acceptability of the intervention and the feasibility of a subsequent conclusive trial. The delivery of iCBT may help to address the issue of treatment access in an extensive geographical region and provide immediate implications as a treatment resource for GD in practice.

A - 24 Treatment Response to Internet-Delivered Cognitive Behavioral Therapy for Depression in Multiple Sclerosis

Abstract Objective A recent randomized-controlled (phase III) clinical trial examined the efficacy of an internet-delivered cognitive behavioral therapy (iCBT) intervention designed to treat depressive symptoms in persons with multiple sclerosis (PwMS). Significant mean reductions in depressive symptoms were found in the stand-alone iCBT and guided-iCBT conditions compared to the control group. The purpose of the current study was to identify the proportion of PwMS who responded to iCBT (stand-alone and guided) for depression compared to a waitlist control group. Method 224 PwMS completed the Beck Depression Inventory-II (BDI-II) to measure depression severity at baseline and post-intervention. Reliable change index (RCI) scores for depressive symptoms were calculated for each participant. Clinical significance was determined using the 95th percentile cutoff (RCI = ± 1.96). Results Combining the stand-alone and guided-iCBT (n = 147) groups, 89 PwMS (61%) demonstrated a reliable decrease in BDI-II scores, whereas 58 PwMS (39%) did not show a reliable decrease. For waitlist controls (n = 77), 19 PwMS (25%) showed a reliable decrease in BDI-II scores, χ2(2, N = 224) = 33.82, p < 0.001, φ = 0.39. Conclusions We found that the iCBT treatment was highly effective, with 61% of PwMS showing a reliable decline in depressive symptoms compared with only 25% of waitlist controls. Still, generally consistent with previous research, almost 40% of PwMS did not respond to iCBT for depression. Future work will investigate baseline cognitive, psychosocial, and disease-related predictors of response to iCBT to better understand treatment outcomes and possible targets to optimize interventions for depression in MS.

Combining endpoint and change data did not affect the summary standardised mean difference in pairwise and network meta-analyses: An empirical study in depression.

When studies use different scales to measure continuous outcomes, standardised mean differences (SMD) are required to meta-analyse the data. However, outcomes are often reported as endpoint or change from baseline scores. Combining corresponding SMDs can be problematic and available guidance advises against this practice. We aimed to examine the impact of combining the two types of SMD in meta-analyses of depression severity. We used individual participant data on pharmacological interventions (89 studies, 27,409 participants) and internet-delivered cognitive behavioural therapy (iCBT; 61 studies, 13,687 participants) for depression to compare endpoint and change from baseline SMDs at the study level. Next, we performed pairwise (PWMA) and network meta-analyses (NMA) using endpoint SMDs, change from baseline SMDs, or a mixture of the two. Study-specific SMDs calculated from endpoint and change from baseline data were largely similar, although for iCBT interventions 25% of the studies at 3 months were associated with important differences between study-specific SMDs (median 0.01, IQR -0.10, 0.13) especially in smaller trials with baseline imbalances. However, when pooled, the differences between endpoint and change SMDs were negligible. Pooling only the more favourable of the two SMDs did not materially affect meta-analyses, resulting in differences of pooled SMDs up to 0.05 and 0.13 in the pharmacological and iCBT datasets, respectively. Our findings have implications for meta-analyses in depression, where we showed that the choice between endpoint and change scores for estimating SMDs had immaterial impact on summary meta-analytic estimates. Future studies should replicate and extend our analyses to fields other than depression.

Economic evaluation of Be a Mom, a web-based intervention to prevent postpartum depression in high-risk women alongside a randomized controlled trial

BackgroundPostpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. MethodsThis economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. ResultsOver 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (−176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. LimitationsResults have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. ConclusionsThis study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD.

Implementing internet-based cognitive behavioural therapy (moodgym) for African students with symptoms of low mood during the COVID-19 pandemic: a qualitative feasibilty study.

Online therapies have been shown to be effective in improving students' mental health. They are cost-effective and therefore have particular advantages in low-income countries like Zambia where mental health resources are limited. This study aimed to explore the perceived impact of the COVID-19 pandemic and the feasibility of implementing an Internet-Based Cognitive Behavioural Therapy (iCBT) intervention ('moodgym') to improve resilience in vulnerable Zambian students. The study was a qualitative interview study. Participants identifying as having symptoms of low mood and completing a baseline, online survey (n = 620) had the option to volunteer for a semi-structured interview to explore views about their experience of the pandemic and the acceptability and perceived benefits and limitations of using moodgym. A total of 50 students (n = 24 female, n = 26 male) participated in the study. One theme with 4 sub-themes, captured the severe emotional and social impact of the COVID-19 pandemic. A second, very strong theme, with 5 sub-themes, reflected the considerable negative effects of the pandemic on the students' educational experience. This included the challenges of online learning. The third theme, with three subthemes, captured the benefits and acceptability of moodgym, particularly in terms of understanding the relationship between thoughts and feelings and improving academic performance. The fourth theme described the technical difficulties experienced by students in attempting to use moodgym. COVID-19 caused fear and impacted wellbeing in vulnerable students and severely impaired the quality of students' educational experience. The findings suggest that moodgym might be a valuable support to students in a low-income country.

Can Emotional Working Memory Training Improve Cognitive Behavioral Therapy Outcomes for Social Anxiety Disorder: A Pilot Study.

Social anxiety disorder (SAD) models highlight maladaptive attention as a maintaining factor of SAD, potentially negatively impacting how individuals with SAD engage with cognitive behavioral therapy (CBT) content in a therapist's presence. Emotional working memory training (eWMT) has been shown to improve affective attentional control. This pilot study assessed the proposed methodology for a randomized controlled trial (RCT) to determine whether eWMT, by improving attentional control prior to internet-based CBT (iCBT), results in better CBT outcomes. The RCT would be considered feasible if the pilot study achieved rates ≥80% for eligible participants recruited, study measures completion, intervention completion, and participant retention. Results from 10 randomized participants showed rates ≥80% for recruitment of eligible participants and iCBT intervention completion. Completion of study measures, eWMT and Placebo training interventions, and participant retention were <80%. Results highlight the need to consider strategies to improve the methodology prior to the RCT.

Pathological network changes in patients with social anxiety disorder before and after an Internet-based CBT

A network perspective may shed light on the understanding of Internet-based CBT efficacy for social anxiety disorder. Previous cross-sectional evidence revealed a densely interconnected network for individuals with social anxiety. Yet, longitudinal network changes before and after ICBT are lacking. This study aimed to investigate pathological network changes with Graphical Gaussian Model among patients with social anxiety disorder (n = 249). Social phobia scale (SPS) and Social interaction anxiety scale (SIAS) were measured before and after 8 weeks Internet-based CBT. Results revealed the connection between symptom tension when speaking and symptom awkward when being watched was the most robust edges during ICBT interventions. The pathological network benefited from ICBT and exhibited modification in several prominent interconnections. The overall network connectivity continues to exhibit comparable strength after ICBT. This study represents the first examination of social anxiety network changes after patients with SAD completed a systematic ICBT. Changes in critical edges and nodes provide valuable insights for the design and efficacy assessment of ICBT interventions.

For Whom and for How Long Does the “Be a Mom” Intervention Work? A Secondary Analysis of Data From a Randomized Controlled Trial Exploring the Mid-Term Efficacy and Moderators of Treatment Response

This study explored clinical and sociodemographic moderators of treatment response to “Be a Mom”, an internet-based cognitive behavioral therapy (iCBT) intervention, from baseline to postintervention, in women at high risk for postpartum depression (PPD). The study also assessed the stability of women’s treatment gains from baseline to 4-months postintervention (follow-up). This open-label randomized controlled trial (RCT) involved a sample of 1,053 postpartum Portuguese women identified as being at high risk for PPD (i.e., having a score of 5.5 or higher on the Postpartum Depression Predictors Inventory-Revised); participants were allocated to “Be a Mom” intervention group or a waiting-list control group, and completed self-report measures at baseline, postintervention, and a 4-month follow-up (554 women completed follow-up assessments). Depressive and anxiety symptoms were measured using the Edinburgh Postnatal Depression Scale and the anxiety subscale of the Hospital Anxiety and Depression Scale, and flourishing/positive mental health was assessed with the Mental Health Continuum. Regression models and linear mixed models were used to examine moderators of treatment and the mid-term efficacy of the “Be a Mom” intervention, respectively. The results revealed that treatment completion, higher depression scores at baseline, and higher income levels were linked to greater symptom reduction and positive mental health enhancement. Moreover, the efficacy of the “Be a Mom” intervention was supported at the 4-month follow-up. The “Be a Mom” intervention appears to be an effective iCBT tool for reducing psychological distress and enhancing positive mental health in women at risk for PPD, with therapeutic improvements maintained over a 4-month period.

Tailored internet-delivered cognitive behavioral therapy for individuals experiencing psychological distress associated with climate change: A pilot randomized controlled trial

Even among people who are not directly impacted by the consequences of climate change, perceptions about the ongoing crisis can have a negative effect on mental health and well-being. However, empirical evidence on interventions aiming to provide support is currently scarce. In order to address this issue, a pilot-RCT was carried out to investigate the effects of a novel ICBT treatment program. Sixty participants (23–73 years) were recruited and randomly allocated to eight weeks of therapist-supported ICBT (n = 30) or a wait-list control condition (n = 30). Measures of depressive symptoms, stress, and quality of life were used as primary outcomes, while measures of anxiety, insomnia, climate change–related distress, pro-environmental behaviour, and alcohol use were used as secondary outcomes. The treatment group had moderate to large between-group effects compared to the waitlist group on measures of depression (d = 0.87), stress (d = 0.76), quality of life (d = 0.79) and climate change–related distress (d = 0.79). There were no significant between-group differences on the other outcome measures. The results from this pilot-RCT indicate that individually tailored ICBT can be an effective way to reduce psychological distress associated with climate change without reducing pro-environmental behaviour.

Abstract 14315: Does Gender Moderate the Effect of Virtual Cognitive Behavioral Therapy Interventions on Depressive Symptoms in Rural Cardiac Patients? Preliminary Analysis of the Combat Study

Background: Depressive symptoms are common in patients with coronary heart disease (CHD) and heart failure (HF) living in rural areas and are associated with worse health outcomes. Cognitive behavioral therapy (CBT) can effectively improve depressive symptoms in patients with CHD and HF, however, traditional CBT is not accessible to most rural individuals, and some, particularly males, may be reluctant to participate in traditional CBT even if available. Therefore, we developed and tested two types of virtual CBT, video conferences with a therapist (vCBT) and self-directed CBT (iCBT). Aim: To determine whether gender moderated the effect of vcCBT or iCBT interventions on depressive symptoms in rural people with CHD and HF. Methods: This is a preliminary analysis of 4-month outcomes in an ongoing 12-month randomized comparative effectiveness trial. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9). Gender was self-identified. Participants with at least mild depressive symptoms were enrolled. Participants were randomly assigned to either a 6-8 week vcCBT or iCBT without a face-to-face therapist. Repeated measures ANOVA was performed to determine whether gender interacted with either intervention to produce an effect on depressive symptoms at 4-months compared with baseline. Results: Participants (N=143) were on average 57 years old, 51% female, and 99.3 % non-Hispanic. At baseline, mean PHQ-9 score for males was 10 ± 5 and 12 ± 5 for females (p-value=0.002). Both intervention groups had a significant decrease in depressive symptoms over time (p&lt;0.001 for group by time interaction). There was no between-group difference in improvement of depressive symptoms (p=0.415). There was no moderating interaction of gender by intervention group on depressive symptoms (p=0.502). Conclusion: Both interventions resulted in a significant decrease in depressive symptoms. The lack of a gender moderating effect demonstrates that both interventions were equally effective in males and females.

Long-Term Efficacy of Internet-Based Cognitive Behavioral Therapy Self-Help Programs for Adults With Depression: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Depression is a worldwide mental disorder and a leading cause of disability. Many people with depression do not want to take medication or have the motivation to seek psychotherapy treatment for many reasons. Guided internet-based self-help programs may be a promising solution for addressing these issues. This kind of intervention has proven to be effective in reducing depression symptoms on a short-term scale. However, as treatment often is a long-term rehabilitation process, it is important to examine not only the short-term effects of internet-based cognitive behavioral therapy (iCBT) self-help treatment but also the follow-up or long-term efficacy of this kind of intervention. This systematic review and meta-analysis aimed to identify studies that examined follow-up data ≥8 weeks after posttreatment measurements and thereby examined the long-term efficacy of iCBT self-help programs with minimal weekly guidance for people with depression. It aimed to analyze the long-term efficacy of iCBT treatments compared to control conditions as well as long-term efficacy within the iCBT treatment conditions. Additionally, it aimed to conduct subgroup analyses according to the follow-up time points for each outcome. Finally, it examined long-term improvements in quality of life. The Cochrane Collaboration Depression, Anxiety, and Neurosis Controlled Trials Register (CCDANCTR), grey literature, reference lists, and correspondence were used to search for published and unpublished randomized controlled trials (RCTs) that reported the long-term or follow-up efficacy of computer-based or iCBT self-help treatments for depression with minimal guidance of up to 10 min/wk. The search took place between 2015 and 2022 (October). The search resulted in a total of 2809 study abstracts, of which 15 studies (with 17 samples) met all inclusion criteria and were included in the long-term analysis. The results showed that the depression outcomes of all follow-up time points together in the treatment conditions were favored over the control conditions with a medium effect size of 0.43 (n=1689 participants; 9 RCTs; standardized mean difference [SMD] -0.43, 95% CI -0.67 to -0.20; P<.001). The analysis of long-term efficacy within the iCBT treatment conditions showed that the follow-up outcomes of the treatment groups were favored over the posttreatment outcomes with a small effect size of 0.20 (n=2196 participants; 17 RCTs; SMD 0.20, 95% CI 0.07-0.49; P=.003). Findings for improving quality of life also showed that the iCBT conditions were favored over the control conditions with a small effect size of 0.19 (n=1345 participants; 3 RCTs; SMD 0.19, 95% CI 0.08-0.30; P<.001). This systematic review and meta-analysis found that iCBT self-help interventions had a superior long-term efficacy for individuals with depressive symptoms compared to control groups. The within-group analysis of iCBT treatment conditions also showed statistically significant improvements in reducing depressive symptoms at follow-up compared to posttreatment measurements.

Evaluation of a Web-Based Self-Help Intervention for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial.

Generalized anxiety disorder (GAD) is a highly prevalent and severely distressing condition that can lead to functional impairments and is considered one of the most difficult anxiety disorders to treat. Following new technological developments, a highly structured cognitive behavioral therapy (CBT) approach that has already shown success in face-to-face psychotherapy can be implemented: internet-delivered CBT (iCBT). There is now evidence for the efficacy of both guided and unguided iCBT interventions for GAD regarding symptom reduction. To establish the usefulness of such interventions, we plan to evaluate the efficacy of a web-based self-help program (Selfapy) for GAD in a relatively large sample. We aim to assess effects beyond symptom reduction, including effects on well-being, functioning, and mental health literacy, as well as the effect on health care burden, while testing the intervention in conditions comparable to routine care. Patients (n=156) who have been diagnosed with GAD, are aged between 18 and 65 years, have internet access, and have sufficient German language skills will be recruited for this study. The intervention group (n=78) will receive access to the 12-week self-help web-based program Selfapy. The waitlist control group (n=78) will receive no intervention in the context of the study. However, both groups will be allowed to access further health care services (eg, psychotherapy, medication), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1) and 6 weeks (T2) and 12 weeks (T3) after the start of the intervention. The primary outcome will be generalized anxiety symptoms and quality of life at T3. Additional outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and negative effects. By May 2023, all participants had finished the trial and the report was being prepared for publication. Web-based interventions may be an important addition to the German health care system to reduce barriers to treatment access. Further, they may prove cost-effective for the treatment of GAD. Deutsches Register Klinischer Studien DRKS00023799; https://tinyurl.com/22bds38x. DERR1-10.2196/41440.

Effects of digital cognitive behavioral therapy for depression on suicidal thoughts and behavior: Protocol for a systematic review and meta-analysis of individual participant data.

Digital cognitive behavioral therapy (i-CBT) interventions for the treatment of depression have been extensively studied and shown to be effective in the reduction of depressive symptoms. However, little is known about their effects on suicidal thoughts and behaviors (STB). Information on the impact of digital interventions on STB are essential for patients' safety because most digital interventions are self-help interventions without direct support options in case of a suicidal crisis. Therefore, we aim to conduct a meta-analysis of individual participant data (IPDMA) to investigate the effects of i-CBT interventions for depression on STB and to explore potential effect moderators. Data will be retrieved from an established and annually updated IPD database of randomized controlled trials investigating the effectiveness of i-CBT interventions for depression in adults and adolescents. We will conduct a one-stage and a two-stage IPDMA on the effects of these interventions on STB. All types of control conditions are eligible. STB can be measured using specific scales (e.g., Beck scale suicide, BSS) or single items from depression scales (e.g., item 9 of the PHQ-9) or standardized clinical interviews. Multilevel linear regression will be used for specific scales, and multilevel logistic regression will be used for treatment response or deterioration, operationalized as a change in score by at least one quartile from baseline. Exploratory moderator analyses will be conducted at participant, study, and intervention level. Two independent reviewers will assess the risk of bias using the Cochrane Risk of Bias Tool 2. This IPDMA will harness the available data to assess the effects (response and deterioration) of i-CBT interventions for depression interventions on STB. Information about changes in STB is essential to estimate patients' safety when engaging in digital treatment formats. We will pre-register this study with the open science framework after article acceptance to ensure consistency between online registration and the published trial protocol.

Commentary on Hyland et al.: Digital treatment for alcohol use disorders - challenges and opportunities.

Hyland and colleagues found no significant effects of an internet-delivered cognitive behavioral therapy intervention (iCBT) as addendum to treatment as usual in individuals with moderate alcohol use disorders. While findings can be attributed partially to methodological issues, future studies should focus upon patient preferences and include potential side effects of internet-based interventions. In the field of problematic alcohol consumption, digital interventions have shown promise in non-clinical populations [1]; however, little is known about their efficacy in clinical populations fulfilling criteria for alcohol use disorders (AUDs). Internet-delivered treatment has rapidly evolved as an option for various mental disorders. First meta-analyses show positive effects when compared to non-active controls in disorders such as depression and agoraphobia [2-4], but also for addictive disorders, especially behavioural addictions [5] and tobacco smoking [6]. Given that disorders due to alcohol and/or drugs are highly stigmatized, internet-delivered interventions might be a relevant tool for narrowing the treatment gap in the field. In their excellently conducted randomized controlled trial (RCT), Hyland and colleagues [7] found only weak evidence for an internet-delivered cognitive behavioral therapy (iCBT) intervention as addendum to treatment as usual (TAU) in individuals with AUDs compared to TAU. However, it has to be taken into account that, as comparator in this study, TAU included far more evidence-based components than would usually be expected in most treatment systems world-wide. The high rate of participants willing to take (and receiving) medication is particularly impressive: data from the United States show that only 16.3% of all speciality treatment programmes for alcohol use disorders offered any single medication for AUD treatment [8]. Furthermore, as all participants in the Hyland et al. study were self-selected, the initial motivation to change already might have produced strong effects, especially if we consider the high rates of unassisted recovery that are common in alcohol use disorders [9]. Another encouraging finding is that overall treatment initiation and completion rates are relatively high compared to digital self-help interventions in the field of affective and anxiety disorders [10], where efficacy of these interventions has already been demonstrated. There is no evidence that guided or unguided internet-delivered interventions for AUDs are associated with lower rates of treatment uptake compared to face-to-face delivery. A prior study from the research group of Hyland et al. on a therapist-guided iCBT intervention compared to therapist-delivered CBT showed no differences in uptake numbers between the two conditions, and both interventions did not differ on outcomes [11]. Another RCT on iCBT as a stand-alone intervention for individuals with AUDs [12] even showed that retention rates were better in the iCBT condition compared to therapist-delivered CBT, and that both conditions were superior compared to TAU (which included lower doses of treatment compared to the Hyland et al. study). Given that internet-delivered treatment requires a high level of patient engagement, future studies should take into account the interaction between type of treatment and patient preferences. Internet-delivered interventions might be a good option for some, but certainly not for all, patients suffering from AUDs. A systematic review on effects of matching patient preferences to treatment in the field of substance use disorders suggests that treatment effects might be improved, although findings were inconsistent [13]. Patient preferences have become increasingly important for the development of clinical interventions, and they could play an important role for improving treatment uptake and outcomes by affected individuals [14]. Finally, only recently have studies on the efficacy of treatment assessed potential side effects. A potential risk of digital interventions is that these interventions might incorrectly be viewed as sufficient by some individuals who otherwise would be willing to engage in other evidence-based treatments. The significant difference between the conditions in the Hyland et al. study regarding receipt of medication shows the need for further rigorous, well-conducted studies. For a more detailed understanding on processes of change in newly developed interventions, mixed-methods studies that include the experiences of patients are warranted. GB conceptualized and wrote the manuscript. None.

An Internet-Based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders: a Study Protocol for a Randomized Controlled Trial

IntroductionAnxiety disorders are the most prevalent mental health conditions among children and adolescents. However, it is estimated that less than 25% of all children and adolescents with an anxiety disorder receive professional help. Thus, it is of utmost importance to develop novel interventions that aim to increase treatment accessibility.ObjectivesThe aim of this study is threefold, to determine the effectiveness of CoolMinds, an iCBT intervention for adolescents with anxiety disorders. In addition to investigate predictive factors and the networks between symptoms, severity and change from pre- to post- treatment.MethodsThe study is designed as a three-armed randomized controlled trial comparing iCBT with planned feedback, iCBT with on-demand help and a waitlist control, with 56 patients in each group. The participants in the two treatment conditions will receive 12 weeks of iCBT, while participants in the waitlist control wait for 12 weeks, before receiving iCBT with planned feedback. The participants in the two iCBT conditions will be randomized to get a booster session or not, 12 weeks after finishing treatment. The participants are adolescents between the age of 12 and 17 years and their parents. The families must live in the Region of Southern Denmark, and the adolescents must have a principal anxiety diagnosis according to DSM-5 criteria. The primary outcome measure are the Youth Online Diagnostic Assessment - child and parent versions. Outcomes will be evaluated at baseline, post-treatment and at the 3-, 6- and 12-month follow-ups. Symptoms of anxiety and depression are also measured between each session with PHQ-9 and S-SCAS.ResultsThe results from this study will be submitted to high-status international and peer-reviewed journals, as well as be presented at national and international conferences.ConclusionsThis study will allow us to determine the efficacy of iCBT in adolescents with anxiety, where parent involvement is emphasized as part of the treatment. The results from this study intends to enhance accessibility of evidence-based treatment for adolescents with anxiety.Disclosure of InterestNone Declared

Opportunities for fostering a positive therapeutic relationship in an Internet‐based cognitive behavioural therapy for dementia caregivers

AbstractObjectiveResearch has shown that therapists can develop a positive therapeutic relationship in the Internet setting and that the therapeutic relationship plays a role in treatment outcome. However, little is known about how therapists foster a positive therapeutic relationship in the Internet setting. Therefore, the current study assesses the extent to which therapists apply techniques that are recommended in the face‐to‐face setting when communicating with participants of an Internet‐based cognitive behavioural therapy (iCBT) intervention.MethodQualitative content analysis was conducted to analyse therapists' messages sent to clients during the course of an asynchronous, text‐based iCBT intervention for caregivers of people with dementia. A total of 216 written messages from four therapists to 27 participants were analysed. Based on the motivational attunement framework of therapist behaviour, a deductive coding system was developed, and the intercoder reliability was satisfactory.ResultsThrough qualitative content analysis, a variety of techniques were found in the therapeutic messages: 12 main categories and six subcategories of therapeutic techniques that satisfy the four basic needs according to Grawe were identified. Therapists most frequently addressed the need for attachment (41%), followed by orientation and control (28%), self‐esteem (24%) and pleasure (7%).ConclusionsThe results indicated that online therapists implemented many of the techniques that are recommended and applied in the face‐to‐face setting to foster a positive therapeutic relationship. Results can be used to develop training for online therapists and manuals for Internet interventions.

Effect of internet-based cognitive behaviour therapy among women with negative birth experiences on mental health and quality of life - a randomized controlled trial

BackgroundGiving birth is often a positive experience, but 7–44% have negative experiences and about 4% develop posttraumatic stress disorder following childbirth (PTSD FC). This randomized controlled trial (RCT) investigated the effect of internet-based cognitive behaviour therapy (iCBT) for women with negative birth experiences and/or at risk for PTSD FC.MethodsThis was a superiority nonblinded multicentre RCT comparing iCBT combined with treatment as usual (TAU) with TAU only. Data were collected through questionnaires at baseline, at 6 weeks, 14 weeks and 1 year after randomization. The RCT was conducted at four delivery clinics in Sweden and participants were recruited from September 2013 until March 2018. Women who rated their childbirth experience as negative on a Likert scale, and/or had an immediate caesarean section or a haemorrhage of > 2000 ml were eligible. Primary outcomes were symptoms of posttraumatic stress (Traumatic Event Scale, TES) and symptoms of depression (Edinburgh Postnatal Depression Scale, EPDS). Secondary outcomes were satisfaction with life (Satisfaction With Life Scale, SWLS) and coping (Ways of Coping Questionnaire, WCQ).ResultsOut of 1810 eligible women, 266 women were randomised to iCBT+TAU (n = 132) or to TAU (n = 134). In the iCBT+TAU group 59 (45%) completed the treatment. ICBT+TAU did not reduce PTSD FC at 6 weeks, at 14 weeks, or at 1 year follow-up compared with TAU, according to the TES. Both the ITT and completer analyses showed significant time and quadratic time effects due to reduction of symptoms in both groups on the TES (re-experience subscale) and on the EPDS, and significant time effect on the self-controlling subscale of the WCQ (which increased over time). There was also a significant main effect of group on the SWLS where the TAU group showed higher initial satisfaction with life. Exploratory subgroup analyses (negative birth experience, immediate caesarean section, or severe haemorrhage) showed significant time effects among participants with negative birth experience on re-experience, arousal symptoms and depressive symptoms.ConclusionsThe ICBT intervention did not show superiority as both groups showed similar beneficial trajectories on several outcomes up to 1 year follow-up. This intervention for women with negative birth experiences and/or at risk for PTSD FC was feasible; however, the study suffered from significant drop out rate. Future studies with more narrow inclusion criteria and possibly a modified intervention are warranted.Trial registrationISRCTN39318241. Date for registration 12/01/2017.