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

BACKGROUND: Posttraumatic 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. METHODS: The 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. DISCUSSION: This study is expected to contribute to valuable knowledge on the efficacy of internet-based interventions for posttraumatic stress disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT06475716. Registered on 25 June 2024.

Uptake of a self-guided digital treatment for depression and anxiety: A qualitative study exploring patient perspectives and decision-making.

BACKGROUND: Despite the demonstrated efficacy and potential scalability of self-guided digital treatments for common mental health conditions, there is substantial variability in their uptake and engagement. This study explored the decision-making processes, influences and support needs of people taking up a self-guided digital treatment for anxiety and/or depression. METHODS: Australian-based adults (n = 20) were purposively sampled from a trial of self-guided digital mental health treatment. One-to-one, semistructured interviews were conducted, based on the Ottawa Decision-Support Framework. Interviews were transcribed verbatim and analysed thematically using framework methods. Baseline sociodemographic, clinical and decision-making characteristics were also collected. RESULTS: Analyses yielded four themes. Theme 1 captured participants' openness to try self-guided digital treatment, despite limited deliberation on potential downsides or alternative options. Theme 2 highlighted that immediacy and ease of access were major drivers of uptake, which participants contrasted with gaps in access and continuity of care in face-to-face services, especially rurally. Theme 3 centred on participants as the main agents in their decision-making, with family and health professional attitudes also reportedly influencing decision-making. Theme 4 revealed participants' primary motivations for deciding to take up treatment (e.g., the potential to increase insight and coping skills), while also acknowledging that pre-existing characteristics (e.g., health and digital literacy, insight) determined participants' personal suitability for self-guided digital treatment. CONCLUSION: Findings help to elucidate the decision-making influences and processes amongst people who started a self-guided treatment for depression and anxiety. Additional information and decision support resources appear warranted, which may also improve the accessibility of self-guided treatments. PUBLIC OR PATIENT CONTRIBUTION: Patients were interviewed about their views and experiences of decision-making about accessing and taking up treatment. As such, patient contribution to the research was as study participants.

Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial.

BACKGROUND: Depression is the most prevalent mental health condition in older adults. However, not all evidence-based treatments are easily accessible. Web-delivered cognitive behavioral therapy (wCBT) facilitated by laypersons is a viable treatment alternative. OBJECTIVE: This randomized controlled trial aims to evaluate the efficacy of a novel wCBT program, Empower@Home, supported by trained lay coaches, against a waitlist attention control. Empower@Home is among the very few existing wCBT programs specifically designed for older adults. The primary objective was to assess the efficacy of the intervention compared with attention control. The secondary objective was to evaluate the program's impact on secondary psychosocial outcomes and explore potential change mechanisms. METHODS: Older adults (N=70) were recruited via web-based research registries, social media advertisements, and community agency referrals and randomly assigned to either the intervention or control group in a 1:1 allocation ratio. The intervention group received access to Empower@Home, which included 9 web-delivered self-help lessons and weekly telephone coaching sessions by a trained layperson over 10 weeks. The control group received weekly friendly phone calls and depressive symptom monitoring. The primary clinical outcome was the severity of depressive symptoms assessed using the Patient Health Questionnaire-9. The secondary clinical outcomes included anxiety, anger, social isolation, insomnia, pain intensity, and quality of life. Linear mixed modeling was used to determine the treatment effects on depression, and 2-tailed t tests were used to assess within-group changes and between-group differences. RESULTS: Most participants in the intervention group completed all 9 sessions (31/35, 89%). The usability and acceptability ratings were excellent. The intervention group had a large within-group change in depressive symptoms (Cohen d=1.22; P<.001), whereas the attention control group experienced a medium change (Cohen d=0.57; P<.001). The between-group effect size was significant, favoring the intervention group over the control group (Cohen d=0.72; P<.001). In the linear mixed model, the group-by-time interaction was statistically significant (b=-0.68, 95% CI -1.00 to -0.35; P<.001). The treatment effects were mediated by improvements in cognitive behavioral therapy skills acquisition; behavioral activation; and satisfaction with the basic psychological needs of autonomy, competence, and relatedness. Furthermore, the intervention group showed significant within-group improvements in secondary psychosocial outcomes, including anxiety (P=.001), anger (P<.001), social isolation (P=.02), insomnia (P=.007), and pain (P=.03). By contrast, the control group did not experience significant changes in these outcome domains. However, the between-group differences in secondary outcomes were not statistically significant, owing to the small sample size. CONCLUSIONS: Empower@Home, a wCBT program supported by lay coaches, was more efficacious in reducing depressive symptoms than friendly telephone calls and depression symptom monitoring. Future studies should examine the effectiveness of the intervention in community and practice settings using nonclinician staff already present in these real-world settings as coaches. TRIAL REGISTRATION: ClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/44210.

Introducing and Evaluating the Effectiveness of Online Cognitive Behavior Therapy for Gambling Disorder in Routine Addiction Care: Comparative Cohort Study.

BACKGROUND: Several treatment-related challenges exist for gambling disorder, in particular at-scale dissemination in health care settings. OBJECTIVE: This study describes the introduction of a newly developed internet-delivered cognitive behavioral therapy (iCBT) program for gambling disorder (GD), provided with therapist support in routine addiction care, in a nationally recruited sample in Sweden. The study details the introduction of the iCBT program, evaluates its effectiveness and acceptability, and compares registry outcomes among iCBT patients with other patients with GD at the clinic who received face-to-face psychological treatment as usual. METHODS: The study site was the Stockholm Addiction eClinic, which offers digital interventions for addictive disorders in routine care. The iCBT program was introduced nationally for treatment-seeking patients through the Swedish eHealth platform. After approximately 2 years of routine treatment provision, we conducted a registry study, including ordinary patients in routine digital care (n=218), and a reference sample receiving face-to-face psychological treatment for GD (n=216). RESULTS: A statistically significant reduction in the Gambling Symptom Assessment Scale scores during the treatment was observed (B=-1.33, SE=0.17, P<.001), corresponding to a large within-group Cohen d effect size of d=1.39. The iCBT program was rated high for satisfaction. A registry-based survival analysis, controlling for psychiatric comorbidity, showed that patients receiving iCBT exhibited posttreatment outcomes (re-engagement in outpatient addiction care, receiving new psychiatric prescriptions, enrollment in psychiatric inpatient care, and care events indicative of contact with social services) similar to comparable patients who underwent face-to-face treatment-as-usual. CONCLUSIONS: A lack of randomized allocation notwithstanding, the iCBT program for GD evaluated in this study was well-received by patients in routine addiction care, was associated with the expected symptom decrease during treatment, and appears to result in posttreatment registry outcomes similar to face-to-face treatment. Future studies on treatment mechanisms and moderators are warranted. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-020-00647-5.

Predictors of dropout, time spent on the program and client satisfaction in an internet-based, telephone-assisted CBT anxiety program among elementary school children in a population-based sample.

Increasing evidence has shown that childhood anxiety can be effectively treated by Internet-based cognitive behavioral therapy (ICBT). Being able to predict why participants decide to drop out of such programs enables scarce resources to be used appropriately. The aim of this study was to report dropout predictors for a population-based ICBT intervention aimed at children with anxiety, together with the time they and their parents spent on the program and client satisfaction rates. The study focused on 234 Finnish children aged 10-13 who received an ICBT intervention, with telephone support, for anxiety symptoms, as a part of a randomized control trial. Their parents also had access to Internet-based material and participated in the weekly telephone calls with the coach. Possible drop out factors were explored and these included various family demographics, child and parent psychopathology and therapeutic alliance. Just under a fourth (23.9%) of the children dropped out of the intervention. The risk was higher if the child did not fulfill the criteria for any anxiety diagnosis or reported a poorer therapeutic alliance. Family demographics and the COVID-19 pandemic did not increase the risk. The families spent an average of 127 min on the webpage each week and an average of 32 min on the phone calls. The overall satisfaction with the program was 87% for the children and 95% for the parents. Both the children and the parents found the telephone calls helpful. These findings are important in clinical practice when assessing a family's eligibility for ICBT.

The efficacy of internet-delivered cognitive-behavioral therapy for posttraumatic stress disorder according to the mean age of patients: a systematic review and meta-analysis.

Internet-delivered cognitive-behavioral therapy (I-CBT) is effective in treating post-traumatic stress disorder (PTSD) symptoms, offering enhanced accessibility and cost-effectiveness. However, it's important to note that these technologies may not be suitable for all age groups. Therefore, we conducted a systematic review and meta-analysis to determine if the effectiveness of I-CBT in treating PTSD varies based on the patients' mean age. We conducted a systematic review of the literature, focusing on randomized controlled trials (RCTs) in the ISI Web of Science, PubMed/MEDLINE, and PsycINFO databases. Following this, we performed a meta-analysis and evaluated the risk of bias using the Cochrane risk of bias quality assessment tool. In this study, we examined patient-related factors (civil or military status, age, and gender), clinical characteristics (baseline PTSD severity and type of trauma), and treatment characteristics (type of intervention, synchronous or asynchronous delivery, and the number of sessions) as independent variables. The dependent variable was the reduction in mean PTSD symptoms. Five RCTs out of 1,552 screened studies were included in this review, all of which showed some level of concern regarding potential bias. Our meta-analysis indicates that I-CBT is equally effective regardless of patients' mean age. Since all RCTs included only provide the mean age of the patients, further randomized controlled trials should address the effectiveness of I-CBT among different age groups.

Internet-Based Cognitive Behavioural Treatments for Obsessive-Compulsive Disorder: A Systematic Review and Meta-Analysis.

Obsessive-compulsive disorder (OCD) is a common mental health condition characterized by distressing, intrusive thoughts (obsessions) and repetitive behaviours (compulsions) aimed at reducing anxiety. Internet-based cognitive behavioural therapy (ICBT) has emerged as an effective treatment modality for various mental health disorders. This meta-analysis evaluates the efficacy of guided self-help ICBT (GSH ICBT) and unguided self-help ICBT (SH ICBT) against active and passive control conditions in adults with OCD. A comprehensive systematic literature search yielded 12 randomized controlled trials (RCTs) comprising 15 comparison arms (N = 1416) that met the inclusion criteria. Results indicate that GSH ICBT significantly reduced OCD symptomatology posttreatment compared to active controls (g = 0.378, k = 9), with no significant effects maintained at follow-up (g = 0.153, k = 4). GSH ICBT was also found to be as effective as active CBT interventions in reducing comorbid anxiety and depression symptoms posttreatment (g = 0.278, k = 6) and at follow-up (g = 0.124, k = 4). However, improvements in quality of life were not significant posttreatment (g = 0.115, k = 4) nor at follow-up (g = 0.179, k = 3). Combined GSH and SH ICBT demonstrated large effects on reducing OCD symptoms (g = 0.754, k = 6), medium effects on comorbid symptoms (g = 0.547, k = 6) and small effects on quality of life (g = 0.227, k = 2) when compared to inactive controls. No significant differences were found between GSH and SH ICBT in all measured outcomes posttreatment (OCD: g = 0.098, k = 3; AD: g = 0.070, k = 3; QoL: g = -0.030, k = 1) and at follow-up (OCD: g = 0.265, k = 2; AD: g = 0.084, k = 2; QoL: g = 0.00, k = 1). Sample size was identified as a significant moderator of treatment effects. This paper further explores clinical significance, treatment adherence, therapist time investment and moderator influences of the ICBT. The limitations of the study and recommendations for future research are thoroughly discussed.

Interpersonal factors in internet-based cognitive behavioral therapy for depression: Attachment style and alliance with the program and with the therapist.

Objective This open-trial study examined effects of a culturally-adapted Hebrew version of guided internet-based cognitive behavioural therapy (ICBT) for depression. We examined therapeutic alliance with the therapist and with the programme (content) as potential predictors of outcomes. Furthermore, we examined whether anxious and avoidant attachment styles improved, although relationships were not the focus of treatment. Method: We examined alliance with therapist and alliance with programme and their time-lagged (1 week), longitudinal relationship with depression outcomes, and change in anxious and avoidant attachment during treatment. Results: Depression and insomnia improved significantly (Cohen's d: depression = 1.34, insomnia = 0.86), though dropout was relatively high (49%). Alliance with programme and with the therapist predicted adherence and dropout, whereas only alliance with therapist predicted symptom improvement. Avoidant attachment decreased over treatment whereas anxious attachment did not. Conclusion: A culturally-adapted version of ICBT for depression showed that alliance with therapist and alliance with programme both can play an important role in its effectiveness: alliance with programme and the therapist drive adherence and dropout and alliance with therapist is related to symptom improvement. Although the focus of treatment is not interpersonal, avoidant attachment style can improve following ICBT.

Older Adults Experience with a Layperson-Supported Digital Mental Health Intervention for Depression: Qualitative Insights on Engagement.

OBJECTIVES: This qualitative study examines the experiences of older adults with Empower@Home, an older adult-centered, layperson-supported internet-based cognitive behavioral therapy (iCBT) program for depression, with a focus on engagement-related factors. METHODS: Adults aged 50 or older with at least mild depressive symptoms were recruited from multiple resources. A random subset of participants was invited for a semi-structured qualitative interview during a post-intervention assessment conducted over the phone (N = 148). Interviews were recorded and transcribed verbatim. Transcripts were coded in a multi-phase, team-based approach utilizing inductive coding techniques, followed by thematic analysis to identify key themes. RESULTS: Six key themes regarding engagement emerged: the importance of a structured, skills-based, and self-paced approach; the essential role of weekly coaching for accountability, web interface's ease of use and accessibility; narrative engagement dynamics; enhanced learning through multimodal instruction; and tailoring challenges in iCBT. CONCLUSIONS: Older adult-centered, layperson-supported, and multimodal iCBT can effectively engage older adults in managing their mental health. CLINICAL IMPLICATIONS: iCBT programs can be integrated into various community aging settings. By leveraging each setting's strengths and involving a range of professionals, these programs can play an important role in enhancing older adults' mental health.

Reduced anhedonia following internet-based cognitive-behavioral therapy for depression is mediated by enhanced reward circuit activation.

BACKGROUND: Major depressive disorder (MDD) is a highly prevalent psychiatric condition, yet many patients do not receive adequate treatment. Novel and highly scalable interventions such as internet-based cognitive-behavioral-therapy (iCBT) may help to address this treatment gap. Anhedonia, a hallmark symptom of MDD that refers to diminished interest and ability to experience pleasure, has been associated with reduced reactivity in a neural reward circuit that includes medial prefrontal and striatal brain regions. Whether iCBT can reduce anhedonia severity in MDD patients, and whether these therapeutic effects are accompanied by enhanced reward circuit reactivity has yet to be examined. METHODS: Fifty-two MDD patients were randomly assigned to either 10-week iCBT (n = 26) or monitored attention control (MAC, n = 26) programs. All patients completed pre- and post-treatment assessments of anhedonia (Snaith-Hamilton Pleasure Scale; SHAPS) and reward circuit reactivity [monetary incentive delay (MID) task during functional magnetic resonance imaging (fMRI)]. Healthy control participants (n = 42) also underwent two fMRI scans while completing the MID task 10 weeks apart. RESULTS: Both iCBT and MAC groups exhibited a reduction in anhedonia severity post-treatment. Nevertheless, only the iCBT group exhibited enhanced nucleus accumbens (Nacc) and subgenual anterior cingulate cortex (sgACC) activation and functional connectivity from pre- to post-treatment in response to reward feedback. Enhanced Nacc and sgACC activations were associated with reduced anhedonia severity following iCBT treatment, with enhanced Nacc activation also mediating the reduction in anhedonia severity post-treatment. CONCLUSIONS: These findings suggest that increased reward circuit reactivity may contribute to a reduction in anhedonia severity following iCBT treatment for depression.

A meta-analysis of internet-based cognitive behavioral therapy for military and veteran populations.

BACKGROUND: Military and veteran populations are unique in their trauma exposures, rates of mental illness and comorbidities, and response to treatments. While reviews have suggested that internet-based Cognitive Behavioral Therapy (iCBT) can be useful for treating mental health conditions, the extent to which they may be appropriate for military and veteran populations remain unclear. The goals of the current meta-analysis are to: (1) substantiate the effects of iCBT for military and veteran populations, (2) evaluate its effectiveness compared to control conditions, and (3) examine potential factors that may influence their effectiveness. METHODS: This review was completed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting and Cochrane review guidelines. The literature search was conducted using PsycInfo, Medline, Embase, and Proquest Dissertation & Theses on June 4, 2021 with no date restriction. Inclusion criteria included studies that: (1) were restricted to adult military or veteran populations, (2) incorporated iCBT as the primary treatment, and (3) evaluated mental health outcomes. Exclusion criteria included: (1) literature reviews, (2) qualitative studies, (3) study protocols, (4) studies that did not include a clinical/analogue population, and (5) studies with no measure of change on outcome variables. Two independent screeners reviewed studies for eligibility. Data was pooled and analyzed using random-effects and mixed-effects models. Study data information were extracted as the main outcomes, including study condition, sample size, and pre- and post-treatment means, standard deviations for all assessed outcomes, and target outcome. Predictor information were also extracted, and included demographics information, the types of outcomes measured, concurrent treatment, dropout rate, format, length, and delivery of intervention. RESULTS: A total of 20 studies and 91 samples of data were included in the meta-analysis. The pooled effect size showed a small but meaningful effect for iCBT, g = 0.54, SE = 0.04, 95% CI (0.45, 0.62), Z = 12.32, p < .001. These effects were heterogenous across samples, (I2 = 87.96), Q(90) = 747.62, p < .001. Predictor analyses found length of intervention and concurrent treatment to influence study variance within sampled studies, p < .05. Evaluation of iCBT on primary outcomes indicated a small but meaningful effect for PTSD and depression, while effects of iCBT on secondary outcomes found similar results with depression, p < .001. CONCLUSIONS: Findings from the meta-analysis lend support for the use of iCBT with military and veteran populations. Conditions under which iCBT may be optimized are discussed.

Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial.

BACKGROUND: Non-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up. METHODS: We analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group. RESULTS: Depression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety. CONCLUSIONS: Depression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03096925 .

Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial.

BACKGROUND: The Common Elements Toolbox (COMET) is an unguided digital single-session intervention (SSI) based on principles of cognitive behavioral therapy and positive psychology. Although unguided digital SSIs have shown promise in the treatment of youth psychopathology, the data are more mixed regarding their efficacy in adults. OBJECTIVE: This study aimed to investigate the efficacy of COMET-SSI versus a waiting list control in depression and other transdiagnostic mental health outcomes for Prolific participants with a history of psychopathology. METHODS: We conducted an investigator-blinded, preregistered randomized controlled trial comparing COMET-SSI (n=409) with an 8-week waiting list control (n=419). Participants were recruited from the web-based workspace Prolific and assessed for depression, anxiety, work and social functioning, psychological well-being, and emotion regulation at baseline and at 2, 4, and 8 weeks after the intervention. The main outcomes were short-term (2 weeks) and long-term (8 weeks) changes in depression and anxiety. The secondary outcomes were the 8-week changes in work and social functioning, well-being, and emotion regulation. Analyses were conducted according to the intent-to-treat principle with imputation, without imputation, and using a per-protocol sample. In addition, we conducted sensitivity analyses to identify inattentive responders. RESULTS: The sample comprised 61.9% (513/828) of women, with a mean age of 35.75 (SD 11.93) years. Most participants (732/828, 88.3%) met the criteria for screening for depression or anxiety using at least one validated screening scale. A review of the text data suggested that adherence to the COMET-SSI was near perfect, there were very few inattentive respondents, and satisfaction with the intervention was high. However, despite being powered to detect small effects, there were negligible differences between the conditions in the various outcomes at the various time points, even when focusing on subsets of individuals with more severe symptoms. CONCLUSIONS: Our results do not support the use of the COMET-SSI in adult Prolific participants. Future work should explore alternate ways of intervening with paid web-based participants, including matching individuals to SSIs they may be most responsive to. TRIAL REGISTRATION: ClinicalTrials.gov NCT05379881, https://clinicaltrials.gov/ct2/show/NCT05379881.

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

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

The Overall Anxiety Severity and Impairment Scale as an Outcome Measure in Internet-Delivered Cognitive Behavioral Therapy for Anxiety Disorders: Observational Study.

BACKGROUND: Internet-delivered cognitive behavioral therapy (iCBT) is effective in the treatment of anxiety disorders. iCBT clinical trials use relatively long and time-consuming disorder-specific rather than transdiagnostic anxiety measurements. Overall Anxiety Severity and Impairment Scale (OASIS) is a brief self-report scale that could offer a universal, easy-to-use anxiety measurement option in disorder-specific and transdiagnostic iCBT programs. OBJECTIVE: We aimed to investigate relationships between OASIS and disorder-specific instruments in iCBT. We expected these relationships to be positive. METHODS: We investigated patients in original nationwide iCBT programs for generalized anxiety disorder (GAD), obsessive-compulsive disorder, panic disorder, and social anxiety disorder, which were administered by Helsinki University Hospital, Finland. In each program, anxiety symptoms were measured using both disorder-specific scales (the 7-item Generalized Anxiety Disorder scale, Penn State Worry Questionnaire, revised Obsessive-Compulsive Inventory, Panic Disorder Severity Scale, and Social Phobia Inventory) and by OASIS. A general linear model for repeated measures (mixed models) and interaction analysis were used for investigating the changes and relationships in the mean scores of OASIS and disorder-specific scales from the first session to the last one. RESULTS: The main effect of linear mixed models indicated a distinct positive association between OASIS and disorder-specific scale scores. Interaction analysis demonstrated relatively stable associations between OASIS and the revised Obsessive-Compulsive Inventory (F822.9=0.09; 95% CI 0.090-0.277; P=.32), and OASIS and the Panic Disorder Severity Scale (F596.6=-0.02; 95% CI -0.108 to -0.065; P=.63) from first the session to the last one, while the 7-item Generalized Anxiety Disorder scale (F4345.8=-0.06; 95% CI -0.109 to -0.017; P=.007), Penn State Worry Questionnaire (F4270.8=-0.52; 95% CI -0.620 to -0.437; P<.001), and Social Phobia Inventory (F862.1=-0.39; 95% CI -0.596 to -0.187; P<.001) interrelated with OASIS more strongly at the last session than at the first one. CONCLUSIONS: OASIS demonstrates clear and relatively stable associations with disorder-specific symptom measures. Thus, OASIS might serve as an outcome measurement instrument for disorder-specific and plausibly transdiagnostic iCBT programs for anxiety disorders in regular clinical practice.

From Craft to Labor: How Automation is Transforming the Practice of Psychotherapy.

I argue that the emergence of ICBT (Internet Cognitive Behavioral Therapy), a novel computerized psychotherapeutic intervention, heralds a shift in the status of psychotherapy from craft to labor. Psychotherapy, as is practiced commonly today, retains its status as craft; therapists in managed settings still work within what I term an opaque bubble, their work invisible and uninterrupted, even by their immediate supervisors and managers. The therapists participating in the Israeli Ministry of Health's course training the first cohort of 'online therapists' find themselves in uncharted territory: The automation of psychotherapy in the form of ICBT constitutes the profession's first major 'division of labor,' not only minimizing the role of the human therapists, but rendering their craft transparent and controllable in ways previously unimaginable. This shift is theorized as a transition from a workmanship of risk, to a workmanship of certainty, and the potential degradation of therapists' skills and status is explored.

Linguistic predictors of symptom change in an internet-based cognitive behavioural intervention for prolonged grief symptoms.

This study investigates linguistic predictors of reduction in prolonged grief symptoms following a writing intervention in an internet-based cognitive behavioural therapy for people bereaved by cancer. Data stem from a randomized control clinical trial with 70 people. The Linguistic Inquiry and Word Count program was used to analyse patient language. Absolute change scores and reliable change index were used to calculate reduction in grief symptoms and clinical significant change. Best subset regression and Mann-Whitney U tests were conducted. A higher reduction of prolonged grief symptoms was correlated with more social words in the first module (ß = -.22, p = .042), less risk (ß = .33, p = .002) and body words (ß = .22, p = .048) in the second module and more time words in the third module (ß = -.26, p = .018). Patients with clinically significant change showed a higher median in function words in the first module (p = .019), a lower median in risk words in the second module (p = .019) and a higher median in assent words in the last module (p = .014) compared to patients without clinically significant change. Findings suggest that it may be beneficial for therapists to encourage a more detailed description of patients' relationship with their deceased relative during the first module, a change in perspective during the second module and a summary of past, present and future aspects at the end of therapy. Future studies should include mediation analyses to allow causal attribution of the studied effects.

Short Research Article: Changes in life functioning in a self-help, online program for child and adolescent anxiety.

BACKGROUND: Anxiety-related functional impairment, as reflected by life interference, is a lesser explored but highly relevant treatment outcome, and it is crucial that it be included and examined in the evaluation of treatment outcomes of internet-delivered Cognitive Behavioural Therapy (iCBT). METHODS: This single group, pre-post study examined changes in life interference and anxiety symptoms in a sample of children (n = 1198; mean age 9.66 years) and adolescents (n = 721; mean age 13.66 years) participating in the BRAVE Self-Help program in Australia. RESULTS: Results demonstrated that both children and adolescents showed improvements in anxiety symptoms, with effect sizes ranging from ηp 2  = .194-.318. Reductions in life interference were evident for children (ηp 2  = .008-.044), particularly later in the programme, but adolescents did not show such effects. Adolescents in the low completer group (completing 3-5 sessions) showed increases in at-home interference (ηp 2  = .038). CONCLUSIONS: Adolescents in particular may require more sessions before entrenched life interference, such as that resulting from avoidance behaviours, can be overcome.

Technology-delivered cognitive-behavioral therapy for pediatric anxiety disorders: a meta-analysis of remission, posttreatment anxiety, and functioning.

BACKGROUND: The efficacy of technology-delivered cognitive-behavioral therapy (tCBT) for pediatric anxiety disorders (ADs) is uncertain as no meta-analysis has examined outcomes in trials that used structured diagnostic assessments at pre- and posttreatment. METHODS: We carried out a systematic review and meta-analysis of randomized controlled trials (RCTs) of tCBT for pediatric ADs that included participants <18 years of age with a confirmed primary AD according to a structured diagnostic interview. Nine studies with 711 participants were included. RESULTS: tCBT outperformed control conditions for remission for primary AD (37.9% vs. 10.2%; k = 9; OR = 4.73; p < .0001; I2 = 0%; moderate certainty), remission for all ADs (19.5% vs. 5.3%; k = 8; OR = 3.32; p < .0001; I2 = 0%; moderate certainty), clinician-rated functioning (k = 7; MD = -4.38; p < .001; I2 = 56.9%; low certainty), and caregiver-reported anxiety (k = 7; SMD = 0.27; p = .02; I2 = 41.4%; low certainty), but not for youth-reported anxiety (k = 9; SMD = 0.13; p = .12; I2 = 0%; low certainty). More severe pretreatment anxiety, a lower proportion of completed sessions, no face-to-face sessions, media recruitment, and a larger proportion of females were associated with lower remission rates for primary AD. CONCLUSIONS: tCBT has a moderate effect on remission for pediatric ADs and clinician-rated functioning, a small effect on caregiver-reported anxiety, and no statistically significant effect on youth-reported anxiety. The certainty of these estimates is low to moderate. Remission rates vary substantially across trials and several factors that may influence remission were identified. Future research should examine for whom tCBT is most appropriate and what care to offer the large proportion that does not remit. Future RCTs should consider contrasting tCBT with partial tCBT (e.g., including therapist-led exposure) and/or face-to-face CBT.

Internet-based cognitive-behavioral therapy for premenstrual syndrome: a randomized controlled trial.

BACKGROUND: Premenstrual syndrome (PMS) is a common problem of women of reproductive age, affecting various aspects of their lives. However, limited studies have investigated the effect of internet-based cognitive-behavioral therapy (ICBT) on PMS. Therefore, we aimed to assess whether ICBT can reduce symptom severity of women with PMS and improve their quality of life during the perimenstrual and late follicular phases of menstrual cycle. METHODS: The study included 92 university students aged 18-35 years who had moderate to severe PMS. The participants were allocated into two groups of 46 using block randomization. The intervention group underwent ICBT for two menstrual cycles, while the control group received no intervention. Before and after the intervention, all participants filled the Daily Record of Severity of Problems (DRSP) for two menstrual cycles and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) on days 1-2 and 11-13 of the menstrual cycle. Data were analyzed using univariate general linear models. RESULTS: Four students in the intervention group were lost to follow-up. Following the intervention, the mean score of total PMS symptoms was significantly lower in the intervention group than in the control group (10.4 vs. 20.2, adjusted difference: - 9.9 [95% CI - 13.3 to - 6.6]), and the score of perimenstrual quality of life was significantly higher (64.2 vs. 50.3, 14.1 [8.5 to 19.8]). However, there was no significant intergroup difference in the late follicular quality of life (68.3 vs. 67.3, 1.9 [- 4.4 to 8.1]). CONCLUSIONS: The ICBT could reduce the symptom severity of women suffering from PMS while improving their perimenstrual quality of life. However, it had no significant effect on the late follicular quality of life. Therefore, this intervention can be used for women with PMS. Trial registration The Iranian Registry of Clinical Trials, Identifier: IRCT20100414003706N34, Registered prospectively on 19 June 2019, https://www.irct.ir/trial/38394 .