Parents' acceptability of blended psychological interventions for children with emotional disorders.

Objectives: This study aims to (1) describe parents' knowledge and use of online resources to address children's mental health issues and the family's general internet and technology usage patterns; (2) examine parents' acceptance of blended interventions for children with emotional disorders (ED); and (3) analyse the predictors of parents' intention to use a blended intervention if their children experienced an ED. Method: The sample included 164 Portuguese parents (95.7 % mothers) of children between the ages of 6 and 13 years who completed an online survey. The study was disseminated through social networks, personal contacts of the researchers, and among parents participating in a randomized controlled trial investigating the efficacy of a psychological intervention for children with ED. Results: Only 4.3 % of parents knew about online psychological interventions for children, and only 1.2 % had used them before. Most parents (73.2 %) reported that they would choose face-to-face individual therapy as their first option if their child had any ED, followed by blended therapy (14.8 %). Regression analyses showed that higher levels of parents' intention to use a blended intervention were predicted by their perceptions of the utility or efficacy of this type of delivery format. Discussion/conclusion: These results suggest that although most parents show unfamiliarity with blended psychological interventions for children, they consider it a treatment modality to which they would resort if their children had emotional difficulties. Their intention to use such an intervention seems to be more likely if they perceive it as useful and effective.

Clinical Psychology and the COVID-19 Pandemic: A Mixed Methods Survey Among Members of the European Association of Clinical Psychology and Psychological Treatment (EACLIPT).

Background: The COVID-19 pandemic has affected people globally both physically and psychologically. The increased demands for mental health interventions provided by clinical psychologists, psychotherapists and mental health care professionals, as well as the rapid change in work setting (e.g., from face-to-face to video therapy) has proven challenging. The current study investigates European clinical psychologists and psychotherapists' views on the changes and impact on mental health care that occurred due to the COVID-19 pandemic. It further aims to explore individual and organizational processes that assist clinical psychologists' and psychotherapists' in their new working conditions, and understand their needs and priorities. Method: Members of the European Association of Clinical Psychology and Psychological Treatment (EACLIPT) were invited (N = 698) to participate in a survey with closed and open questions covering their experiences during the first wave of the pandemic from June to September 2020. Participants (n = 92) from 19 European countries, mostly employed in universities or hospitals, completed the online survey. Results: Results of qualitative and quantitative analyses showed that clinical psychologists and psychotherapists throughout the first wave of the COVID-19 pandemic managed to continue to provide treatments for patients who were experiencing emotional distress. The challenges (e.g., maintaining a working relationship through video treatment) and opportunities (e.g., more flexible working hours) of working through this time were identified. Conclusions: Recommendations for mental health policies and professional organizations are identified, such as clear guidelines regarding data security and workshops on conducting video therapy.

Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial.

BACKGROUND: One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. METHODS: The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. DISCUSSION: There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 .

Webcam-Based Online Coaching with Children and Adolescents with Obsessive-Compulsive Disorders - A Single-Case Study.

Objective: Although there is clear evidence-based knowledge regarding state-of-the-art treatment for pediatric obsessive-compulsive disorder (OCD), two main issues remain in clinical practice: (1) Exposure-based cognitive behavioral therapy (CBT) is limited in terms of availability and accessibility or is not adequately provided, and (2) despite large effect sizes of exposure-based CBT, the achieved recovery rates of 50-60 % still show room for improvement. These issues have prompted an increasing focus on delivering exposure-based CBT in new and innovative ways. This study aims to evaluate an intensive therapist-administered online coaching program consisting of exposure with response prevention via video teleconferencing (VTC) as an add-on to weekly outpatient CBT (blended therapy). Method: The blended therapy is examined in n = 5 children and adolescents with OCD using an AB design and multi-informant ratings. Results: This single-case study shows promising results, indicating that a decrease in OCD severity and related functional impairment can be attributed to blended therapy. Moreover, satisfaction with online coaching was high. Conclusions: Despite some principal limitations, the results support the effectiveness and feasibility of blended therapy.

Two sides of the same coin? Patient and therapist experiences with a transdiagnostic blended intervention focusing on emotion regulation.

Introduction: The combination of internet-based intervention and psychotherapy, commonly termed blended therapy (BT), has gained popularity in recent years. While advantages and disadvantages of BT have been identified from the patient and therapist perspective, the two perspectives have rarely been examined within the same treatment. Moreover, almost all available research on patient and therapist experiences with BT is disorder-specific. This study aimed to investigate patient and therapist experiences within the same transdiagnostic BT. Methods: A qualitative analysis of semi-structured interviews with eight patients and eight therapists taking part in a transdiagnostic blended intervention focusing on the topic of emotion regulation was conducted. A qualitative content analysis approach was used. Category frequencies were calculated and similarities and differences between the patient and therapist experience were explored. Results: Ten main themes and 59 subthemes were identified in the category system for patient interviews and ten main themes and 50 subthemes were identified in the category system for therapist interviews. Similarities and differences between the two perspectives were reported with regard to 1) expectations toward the intervention, 2) the internet-based intervention, 3) symptomatology and emotion regulation, 4) the therapeutic relationship and 5) the blended format. Conclusion: This study provides first insights on the experiences with transdiagnostic BT focusing on emotion regulation. Based on the results, different recommendations for the improvement of transdiagnostic BT are made. Future research on patient and therapist experiences with transdiagnostic BT is necessary, in order to further improve the experience of those involved.

Increasing the effectiveness of psychotherapy in routine care through blended therapy with transdiagnostic online modules (PsyTOM): study protocol for a randomized controlled trial.

BACKGROUND: In blended therapy, face-to-face psychotherapy and Internet-based interventions are combined. Blended therapy may be advantageous for patients and psychotherapists. However, most blended interventions focus on cognitive behavioral therapy or single disorders, making them less suitable for routine care settings. METHODS: In a randomized controlled trial, we will compare blended therapy and face-to-face therapy in routine care. We intend to randomize 1152 patients nested in 231 psychotherapists in a 1:1 ratio. Patients in the blended therapy group will receive access to a therapeutic online intervention (TONI). TONI contains 12 transdiagnostic online modules suited for psychodynamic, cognitive behavioral, and systemic therapy. Psychotherapists decide which modules to assign and how to integrate TONI components into the psychotherapeutic process to tailor treatment to their patients' specific needs. We will assess patients at baseline, 6 weeks, 12 weeks, and 6 months. Patients enrolled early in the trial will also complete assessments at 12 months. The primary outcomes are depression and anxiety at 6-month post-randomization, as measured by PHQ-8 and GAD-7. The secondary outcomes include satisfaction with life, level of functioning, personality traits and functioning, eating pathology, sexual problems, alcohol/drug use, satisfaction with treatment, negative effects, and mental health care utilization. In addition, we will collect several potential moderators and mediators, including therapeutic alliance, agency, and self-efficacy. Psychotherapists will also report on changes in symptom severity and therapeutic alliance. Qualitative interviews with psychotherapists and patients will shed light on the barriers and benefits of the blended intervention. Furthermore, we will assess significant others of enrolled patients in a sub-study. DISCUSSION: The integration of online modules which use a common therapeutic language and address therapeutic principles shared across therapeutic approaches into regular psychotherapy has the potential to improve the effectiveness of psychotherapy and transfer it into everyday life as well help save therapists' resources and close treatment gaps. A modular and transdiagnostic setup of the blended intervention also enables psychotherapists to tailor their treatment optimally to the needs of their patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00028536. Registered on 07.06.2022.

Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study.

BACKGROUND: The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed specifically for persistent depressive disorder. However, given the high rates of nonresponse and relapse, there is a need for optimization. Studies suggest that outcomes can be improved by increasing the treatment dose via, for example, the continuous web-based application of therapy strategies between sessions. The strong emphasis in CBASP on the therapeutic relationship, combined with limited therapeutic availabilities, encourages the addition of web-based interventions to face-to-face therapy in terms of blended therapy. OBJECTIVE: The aim of this study was to test an app-based intervention called CBASPath, which was designed to be used as a blended therapy tool. CBASPath offers 8 sequential modules with app-based exercises to facilitate additional engagement with the therapy content and a separate exercise to conduct situational analyses within the app at any time. METHODS: CBASPath was tested in an open pilot study as part of routine outpatient CBASP treatment. Participating patients were asked to report their use patterns and blended use (integrated use of the app as part of therapy sessions) at 3 assessment points over the 6-month test period and rate the usability and quality of and their satisfaction with CBASPath. RESULTS: The results of the pilot trial showed that 93% (12/13) of participants used CBASPath as a blended tool during their therapy and maintained this throughout the study period. Overall, they reported good usability and quality ratings along with high user satisfaction. All participants showed favorable engagement with CBASPath; however, the frequency of use differed widely among the participants and assessment points. Situational analysis was used by all participants, and the number of completed modules ranged from 1 to 7. All participants reported blended use, although the frequency of integration in the face-to-face sessions varied widely. CONCLUSIONS: Our findings suggest that the digital augmentation of complex and highly interactive CBASP therapy in the form of blended therapy with CBASPath is feasible in routine outpatient care. Therapeutic guidance might contribute to high adherence and increase patient self-management. A few adjustments, such as saving entries directly in the app, could facilitate higher user engagement. A randomized controlled trial is now needed to investigate the efficacy and added value of this blended approach. In the long term, CBASPath could help optimize persistent depressive disorder treatment and reduce relapse by intensifying therapy and providing long-term patient support through the app.

The Digital Transformation of Mental Health Care and Psychotherapy - A Market and Research Maturity Analysis.

Digital technology trends for mental health, instantiated with only emerging use cases or already established applications, offer significant potential to improve clinical therapy and care. In this paper, we identify five major trends, mHealth/eHealth, telehealth, artificial intelligence (AI), big data, and biosensors/wearables; describe seven specific technology use cases for mental health care and psychotherapy; and provide an overview of their maturity in practice.

Comparing the Ratio of Therapist Support to Internet Sessions in a Blended Therapy Delivered to Trauma-Exposed Veterans: Quasi-experimental Comparison Study.

BACKGROUND: Blended models of therapy, which incorporate elements of both internet and face-to-face methods, have been shown to be effective, but therapists and patients have expressed concerns that fewer face-to-face therapy sessions than self-guided internet sessions may be associated with lower therapeutic alliance, lower program completion rates, and poorer outcomes. OBJECTIVE: A multisite quasi-experimental comparison study with a noninferiority design implemented in routine clinical care was used to assess webSTAIR, a 10-module blended therapy derived from STAIR (skills training in affective and interpersonal regulation) for trauma-exposed individuals delivered with 10 weekly therapist sessions (termed Coach10) compared to 5 biweekly sessions (Coach5). It was hypothesized that Coach5 would be as good as Coach10 in a range of outcomes. METHODS: A total of 202 veterans were enrolled in the study with 101 assigned to Coach5 and 101 to Coach10. Posttraumatic stress disorder (PTSD) symptoms, depression, emotion regulation, interpersonal problems, and social functioning measures were collected pre-, mid-, and posttreatment, and at a 3-month follow-up. Noninferiority analyses were conducted on symptom outcome measures. Comparisons were made of continuous and categorical measures regarding participant and therapist activities. RESULTS: Participants reported moderate to severe levels of baseline PTSD, depression, or both. Significant reductions were obtained in all symptom measures posttreatment and at the 3-month follow up. Coach5 was not inferior to Coach10 in any outcome. Therapeutic alliance was at an equivalently high level across the 2 treatment conditions; completion rates and web usage were similar. Total session time was substantially less for the Coach5 therapists than the Coach10 therapists. Both programs were associated with a low, but equal number of therapist activities related to scheduling and crisis or motivational sessions. CONCLUSIONS: A blended model delivered with 5 sessions of therapist support was noninferior to 10 sessions in individuals with moderate to severe symptoms. Future studies identifying patient characteristics as moderators of outcomes with high versus low doses of therapist support will help create flexible, technology-based intervention programming.

Blended Therapies and Mobile Phones for Improving the Health of Female Victims of Gender Violence.

We carried out a case study with a group of female victims of gender violence (n = 39) with the objective of evaluating a blended psychotherapeutic intervention. The results show that blended therapies with mobile text messages combined with face-to-face group therapies significantly improved the health of these women. Mood states and the symptoms of depression were measured with a PHQ-9 personal health questionnaire and evolved positively. In the group of women (n = 39) the scores improved from an initial 13.5 (SD = 7.2, range 3-34) to 6.0 at the end of the period of messages (SD = 5.2, range 0-18), which was a significant difference (t (39) = 2.02; p = 0.000). Most of the women stated that the messages had helped them improve their mood (91.6%) and their general health (83.3%), which made them feel more connected to their social environment (80.6%). We observed that adherence to medication for each woman improved. With mixed therapies and mobile phones, social service professionals can incorporate technology into daily practices and offer personalized attention and daily counseling to victims of gender-based violence.

SlowMo therapy, a new digital blended therapy for fear of harm from others: An account of therapy personalisation within a targeted intervention.

OBJECTIVES: SlowMo therapy is a pioneering blended digital therapy for paranoia, augmenting face-to-face therapy with an interactive 'webapp' and a mobile app. A recent large-scale trial demonstrated small-moderate effects on paranoia alongside improvements in self-esteem, worry, well-being and quality of life. This paper provides a comprehensive account of therapy personalisation within this targeted approach. DESIGN: Case examples illustrate therapy delivery and descriptive data are presented on personalised thought content. METHOD: Thought content was extracted from the webapp (n = 140 participants) and coded using newly devised categories: Worries: (1) Persecutory, (2) Negative social evaluation, (3) Negative self-concept, (4) Loss/life stresses, (5) Sensory-perceptual experiences and (6) Health anxieties. Safer thoughts: (1) Safer alternative (specific alternatives to worries), (2) Second-wave (generalised) coping, (3) Positive self-concept, (4) Positive activities and (5) Third-wave (mindfulness-based) coping. Data on therapy fidelity are also presented. RESULTS: Worries: 'Persecutory' (92.9% of people) and 'Negative social evaluation' (74.3%) were most common. 'General worries/ life stresses' (31.4%) and 'Negative self-concept' (22.1%) were present in a significant minority; 'Health anxieties' (10%) and 'Sensory-perceptual' (10%) were less common. Safer thoughts: 'Second-wave (general) coping' (85%), 'Safer alternatives' (76.4%), 'Positive self-concept' (65.7%) and 'Positive activities' (64.3%) were common with 'Third-wave' (mindfulness) coping observed for 30%. Fidelity: Only three therapy withdrawals were therapy related. Session adherence was excellent (mean = 15.2/16; SD = 0.9). Behavioural work was conducted with 71% of people (119/168). CONCLUSION: SlowMo therapy delivers a targeted yet personalised approach. Potential mechanisms of action extend beyond reasoning. Implications for cognitive models of paranoia and causal interventionist approaches are discussed.

Implementation and Evaluation of Therapeutic Online Coaching Using Habit Reversal Training in Children With Tourette's Disorder - A Pilot Study.

Cognitive-behavioral interventions can be difficult to implement in daily routine, which is often essential for generalizing treatment effects to natural settings. Furthermore, there is a lack of adequate care options concerning habit reversal training for children with Tourette's disorder. The objective of this study is to evaluate therapeutic online coaching via videoconferencing in the natural environment of children with Tourette's disorder in addition to face-to-face therapy (blended therapy). Online coaching took place twice a week for a maximum of 12 weeks. In a single-case study (n = 5; patients aged 8-11 years), the first results were obtained for exploratory purposes, especially with regard to the feasibility and reduction of symptoms and impairment. Various outcome measures were assessed (severity of symptoms, impairment, practical implementation, and satisfaction). Despite some principal limitations, the findings provide first hints that blended therapy is feasible and improves symptoms in some children with tics. Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [DRKS00017199].

Healthcare professionals' perspectives on a blended care program in primary care; A qualitative study.

Increasingly, healthcare policies have changed focus from cure and care to behaviour and health. Prevention is becoming more important, which requires a change in the role of healthcare professionals. Healthcare professionals' role is changing from being a therapist to taking on the role of a coach. To prevent chronicity in Medically Unexplained Physical Symptoms (MUPS), an integrated blended care program was developed. To apply this new program in daily practice, it is important to gain insight into the usability. From the healthcare professionals' point of view the concept of usability consists of performance, satisfaction and acceptability. In this qualitative study participants were recruited after participating in the PARASOL program. Demographics were collected. Semi-structured interviews were conducted and analysed using thematic analysis. Ten healthcare professionals (six physical therapists and four mental health nurses) were interviewed. Four themes on usability were identified: (1) Who fits in the program, (2) preparation, (3) experience with the program and (4) interprofessional collaboration. This study gathered healthcare professionals' experiences with and attitudes towards integrating healthcare and offering blended care programs. An integrated blended care program offers the possibility to personalize treatment. Findings show attention should be given to the new responsibilities of healthcare professionals, and their role in integrated and blended care. This new approach of delivering healthcare can facilitate interprofessional collaboration. Achieving sustainable change in patients however still requires instruction and support for healthcare professionals implementing behavioural change techniques.

Feasibility of a blended therapy approach in the treatment of patients with inflammatory myopathies.

BACKGROUND: Inflammatory myopathies (IMs) are a group of rare conditions characterized by proximal and often symmetrical muscle weakness and reduced muscle endurance. The recommended medical treatment is based on corticosteroids in combination with immunosuppressants. This anti-inflammatory therapy serves to inhibit and prevent inflammation but does not influence impaired muscle strength. Exercise, particularly progressive resistance training, plays therefore an important role in IMs management. Blended therapy, a combination of face-to-face treatment and telerehabilitation, may be a powerful therapy option in improving exercise program adherence in these patients. METHODS: The feasibility of a 12-week interactive tablet-based home exercise program combined with face-to-face therapy sessions - a 'blended therapy' approach - was evaluated using a quasi-experimental one-group pre-post comparison design. Primary outcomes were recruitment, attrition and adherence rates, plus measures of acceptance (Technology Acceptance Model Questionnaire (TAM)) and satisfaction (satisfaction questionnaire). Secondary outcomes comprised potential effects of the intervention on muscle strength and function, activity limitation, disability and health-related quality of life. RESULTS: Thirteen of the included 14 participants completed the study without any related adverse events. Mean adherence to exercise program was 84% (range: 25-100%) and participants indicated high acceptance of the intervention with mean TAM scores between 6.1 and 6.5 points. Overall satisfaction with the therapy sessions, the home program, and the technology was good. Approximately half the participants wished for longer training periods and more training sessions per week. There were inconsistent effects on muscle strength, muscle function, activity limitation, disability, and health-related quality of life. CONCLUSION: Blended therapy combining the use of an interactive tablet-based resistance training program with face-to-face therapy sessions is feasible and safe and participants` acceptance with this approach was high. Furthermore, results were obtained that might be useful in selecting appropriate assessments and sample sizes in future trials. TRIAL REGISTRATION: NCT03713151 .

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders.

Introduction: Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. Objective: The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). Methods: A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPYfix/flex) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of N = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0-16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. Discussion: PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. Trial Registration: The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).

E-mental health applications for depression: an evidence-based ethical analysis.

E-mental health applications (apps) are an increasingly important factor for the treatment of depression. To assess the risks and benefits for patients, an in-depth ethical analysis is necessary. The objective of this paper is to determine the ethical implications of app-based treatment for depression. An evidence-based ethical analysis was conducted. The material was meta-reviews and randomized control studies (RCTs) on app-based treatment. Based on the empirical data, an ethical analysis was conducted using the 3-ACES-approach by Thornicroft and Tansella. Apps may empower autonomy, offer an uninterrupted series of contacts over a period of time, show evidence-based benefits for patients with subclinical and mild-to-moderate-symptoms, are easily accessible, may be used for coordinating information and services within an episode of care, and are on the whole cost-effective. Their risks are that they are not suitable for the whole range of severity of mental illnesses and patient characteristics, show severe deficits in the data privacy policy, and a big variability in quality standards. The use of apps in depression treatment can be beneficial for patients as long as (1) the usefulness of an app-based treatment is assessed for each individual patient, (2) apps are chosen according to symptom severity as well as characteristics like the patient's level of self-reliance, their e-literacy, and their openness vis-à-vis apps, (3) manufacturers improve their privacy policies and the quality of apps.

REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. OBJECTIVE: The aim of this study is to examine, for the first time, a new internet-based intervention-REMOTION-that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. METHODS: A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. RESULTS: Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. CONCLUSIONS: This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20936.

Design Considerations for the Integrated Delivery of Cognitive Behavioral Therapy for Depression: User-Centered Design Study.

BACKGROUND: Adherence to computerized cognitive behavioral therapy (cCBT) programs in real-world settings can be poor, and in the absence of therapist support, effects are modest and short term. Moreover, because cCBT systems tend toward limited support and thus low-intensity treatment, they are typically most appropriate for people experiencing mild to moderate mental health difficulties. Blended therapy, that is, combining direct therapist contact with cCBT or psychoeducational materials, has been identified as one possible approach to address these limitations and widen access to individual CBT for depression. Building on the initial success of blended therapy, we explore an integrated approach that seeks to seamlessly combine face-to-face contact, electronic contact, and between-session activities. Integration also considers how the technology can support therapists' workflow and integrate with broader health care systems. The ultimate aim is to provide a structure within which therapists can deliver high-intensity treatments, while also greatly reducing face-to-face contact. OBJECTIVE: The research aimed to explore patients' and therapists' views on using a system for the delivery of individual treatment for depression that integrates face-to-face therapist contact with access to online resources and with synchronous online therapy sessions that allow collaborative exercises, and to establish design requirements and thus key design considerations for integrated systems that more seamlessly combine different modes of communication. METHODS: We conducted a series of four user-centered design studies. This included four design workshops and seven prototype testing sessions with 18 people who had received CBT for depression in the past, and 11 qualitative interviews and three role-play sessions with 12 CBT therapists experienced in the treatment of depression. Studies took place between July and December 2017 in Bristol, United Kingdom. RESULTS: Workshops and prototyping sessions with people who had received CBT identified three important requirements for integrated platforms delivering CBT therapy for depression as follows: (1) features that help to overcome depression-related barriers, (2) features that support engagement, and (3) features that reinforce learning and support the development of new skills. Research with therapists highlighted the importance of the therapist and client working together, the impact of technology on therapists' workflow and workload, challenges and opportunities related to the use of online resources, and the potential of technology to support patient engagement. We use these findings to inform 12 design considerations for developing integrated therapy systems. CONCLUSIONS: To meet clients' and therapists' needs, integrated systems need to help retain the personal connection, support both therapist- and patient-led activities, and provide access to materials and the ability to monitor progress. However, developers of such systems should be mindful of their capacity to disrupt current work practices and increase therapists' workload. Future research should evaluate the impact of integrated systems on patients and therapists in a real-world context.

Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners' Views.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior. OBJECTIVE: This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined. METHODS: Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted. RESULTS: GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included "little knowledge about internet-based interventions" and "patients' lack of familiarity with technology/internet/media" (number of statements, each k=22). Key facilitators were "perceived patient suitability, e.g. well-educated, young" (k=22) and "no conflict with GP's role" (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned. CONCLUSIONS: This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates.

Immediate and long-term effectiveness of adding an Internet intervention for depression to routine outpatient psychotherapy: Subgroup analysis of the EVIDENT trial.

OBJECTIVE: To examine immediate and long-term effectiveness of an adjunctive Internet intervention for depression in a large sample of patients undergoing routine psychotherapy. METHOD: The current study evaluated a subgroup of patients from the Evident trial, a randomized investigation of a 12-week minimally guided Internet intervention (Deprexis) for the treatment of mild to moderate depression. 340 adults (mean age = 43.3 years; 71.7 % female) of the original sample received routine outpatient psychotherapy during the trial period, resulting in a standard psychotherapy group (n = 174) and an augmented therapy group (n = 166). Outcomes were assessed at baseline, post-treatment and 6-month follow-up. RESULTS: Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (d = 0.36; p = .003), and higher mental health-related quality of life (d = 0.34; p = .004). There was no intervention effect on physical health-related quality of life. The same pattern was found at 6-month follow-up, and adjunctive treatment also resulted in increased rates of clinical improvement. Treatment success was independent from therapeutic orientation of combined face-to-face therapy. CONCLUSION: Results indicate that the adjunctive use of the investigated intervention can produce additional and lasting effects in routine outpatient psychotherapy for mild to moderate levels of depression. The study adds to the ongoing evidence on augmented effects of blended treatment. Future studies should investigate different types of blends in diverse populations by means of change-sensitive assessment strategies.