Long-term Effectiveness and Predictors of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Emotional Disorders in Specialized Care: Secondary Analysis of a Randomized Controlled Trial

Background: Transdiagnostic internet-delivered cognitive behavioral therapy (iCBT) for emotional disorders has been shown to be effective in specialized care in the short term. However, less is known about its long-term effects in this specific setting. In addition, predictors of long-term effectiveness may help to identify what treatments are more suitable for certain individuals. Objective: This study aimed to analyze the long-term effectiveness of transdiagnostic iCBT compared with that of treatment as usual (TAU) in specialized care and explore predictors of long-term effectiveness. Methods: Mixed models were performed to analyze the long-term effectiveness and predictors of transdiagnostic iCBT (n=99) versus TAU (n=101) in public specialized mental health care. Outcomes included symptoms of depression and anxiety, health-related quality of life (QoL), behavioral inhibition and behavioral activation, comorbidity, and diagnostic status (ie, loss of principal diagnosis) from baseline to 1-year follow-up. Sociodemographic characteristics (sex, age, and education) and clinical variables (principal diagnosis, comorbidity, and symptom severity at baseline) were selected as predictors of long-term changes. Results: Compared with baseline, transdiagnostic iCBT was more effective than TAU in improving symptoms of depression (b=–4.16, SE 1.80, 95% CI –7.68 to –0.67), health-related QoL (b=7.63, SE 3.41, 95% CI 1.00-14.28), diagnostic status (b=–0.24, SE 0.09, 95% CI –1.00 to –0.15), and comorbidity at 1-year follow-up (b=–0.58, SE 0.22, 95% CI –1.00 to –0.15). From pretreatment assessment to follow-up, anxiety symptoms improved in both transdiagnostic iCBT and TAU groups, but no significant differences were found between the groups. Regarding the predictors of the long-term effectiveness of transdiagnostic iCBT compared with that of TAU, higher health-related QoL at follow-up was predicted by a baseline diagnosis of anxiety, male sex, and the use of psychiatric medication; fewer comorbid disorders at follow-up were predicted by older age and higher baseline scores on health-related QoL; and fewer depressive symptoms at follow-up were predicted by baseline diagnosis of depression. However, this pattern was not observed for baseline anxiety diagnoses and anxiety symptoms. Conclusions: The results suggest that transdiagnostic iCBT is more effective than TAU to target depressive symptoms among patients with emotional disorders. Anxiety symptoms remained stable at 1-year follow-up, with no differences between the groups. Results on predictors suggest that some groups of patients may obtain specific gains after transdiagnostic iCBT. Specifically, and consistent with the literature, patients with baseline depression improved their depression scores at follow-up. However, this pattern was not found for baseline anxiety disorders. More studies on the predictor role of sociodemographic and clinical variable

“Family Connections”, a DBT-Based Program for Relatives of People with Borderline Personality Disorder during the COVID-19 Pandemic: A Focus Group Study

The COVID-19 pandemic has had a significant impact on the family environment due to the difficulties that have been generated by job losses, deaths, increase rates of family and domestic violence, poor mental health outcomes, and estrangement in personal relationships. “Family Connections” (FC) is an internationally renowned DBT-based program that supports the families and caregivers of people with borderline personality disorder. The study took place at a Specialized Health Centre in Spain. A focus group with seven participants was organized for people who had previously attended an FC group. The participants were asked about their experiences during the confinement periods that was caused by COVID-19 as well as their experiences and opinions on relatives, skills practiced, their need to and the advantages of attending the group, and satisfaction with the FC group. The qualitative research web program Dedoose was used for the thematic analysis of the data. The results showed that the participants experienced various experiences during confinement; validation and radical acceptance were determined to be the most useful skills; the importance of professionals and the content as well as the sincerity of attendees and having a safe space were determined to be the greatest benefits of the programs; and the participants all indicated great satisfaction of the program. This study allowed us to explore the experiences of family members of people with BPD with their loved ones during the confinement period caused by the COVID-19 pandemic. We evaluated the use of the FC program skills in the family environment during confinement, and we analyzed the acceptability and satisfaction with the FC program

Predicting response to transdiagnostic iCBT for emotional disorders from patient and therapist involvement

Background Transdiagnostic iCBT has been shown to be effective for the treatment of emotional disorders. Less is known about the optimal level of therapist and patient involvement in these interventions. Specific characteristics of Internet-delivered interventions include treatment adherence (e.g., amount of review of the materials) and guidance (e.g., amount of therapist support). Exploring the importance of these elements in treatment outcome may help to maximize the efficiency of Internet-delivered psychological interventions. Aim In this study, we aimed to analyze the relationship between patient and therapist involvement (i.e., platform usage and amount of therapist guidance) in a sample of patients with emotional disorders who received transdiagnostic iCBT in Spanish public specialized mental healthcare services. Method This is a secondary analysis of a randomized controlled trial. The sample included 63 patients who completed transdiagnostic iCBT for emotional disorders. Platform usage metrics included number of logins into the platform and number of times the participants reviewed the modules. Therapist guidance was measured as the number of support phone calls with a therapist and their total duration (minutes). Logistic regressions and ROC analyses were performed to explore the predictive value of platform usage and therapist guidance in symptom reduction. Clinical outcomes included depressive and anxiety symptoms assessed at baseline and post-intervention. The bivariate relationship between the platform usage and therapist guidance variables was also explored. Results Overall, platform usage and therapist guidance were not associated with symptom improvement. However, the patient and therapist involvement parameters were intercorrelated. Specifically, the number of calls and their duration were associated with a greater number of logins (r = 0.61; p < .001) and more frequent reviews of the modules (0.46 ≤ r ≤ 0.60; p < .001). Higher baseline depression and anxiety were, respectively, associated with greater improvements in depression (r = −0.37, p = .003) and anxiety after treatment completion (r = −0.48, p < .001). Discussion The results suggest that there is no reliable cut-off point for platform usage and therapist guidance in predicting optimal symptom reduction. However, significant associations were found between platform usage and guidance variables that warrant additional research. More research on this topic is necessary to further clarify the role of these and other platform usage and guidance variables in Internet-delivered iCBT outcomes

Interventions for family members and carers of patients with borderline personality disorder: A systematic review

Carers of patients with borderline personality disorder (BPD) experience high levels of distress. Several studies have been carried out on interventions designed to decrease their burden. However, the evidence from these studies has not been summarized. The objective of this work is to explore the clinical utility of interventions developed for family members of patients with BPD. A systematic review was conducted following the PRISMA guidelines (registration number CRD42018107318), including psychological interventions focused on relatives of patients with BPD. The following databases were used: PsycINFO, PubMed, EBSCOhost, and Web of Science. Two independent researchers reviewed the studies to determine whether the eligibility criteria were met. A total of 2,303 abstracts were identified. After duplicates had been removed, 1,746 studies were screened. Finally, 433 full‐text articles were reviewed, yielding 11 studies that satisfied the inclusion criteria. Results show that these interventions with different clinical formats and settings are effective. The quality of the included studies varies, and the empirical support for these programs is still preliminary. The results help to establish a general framework for interventions specifically developed for family members of patients with BPD, but additional efforts should be made to improve the methodological quality of this field of research and more solidly determine the utility of these interventions. Given the paucity of data so far, this information may open up new lines of research to improve the effectiveness of future programs for carers of patients with BPD and help to reduce their burden

Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial

Background: Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments,especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT. Objective: This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol(EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings. Methods: A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a3-month follow-up. Results: The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety(d=0.35), and health-related quality of life (d=−0.45) at posttreatment, and these gains were maintained at the 3-month follow-up.Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants. Conclusions: EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish publicmental health system. The implications of this RCT, limitations, and suggestions for future research are discussed

Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol

Background: CUIDA-TE is an APP that offers transdiagnostic cognitive behavioral therapy focused on enhancing emotion regulation. As a novelty, it incorporates ecological momentary interventions (EMI), which can provide psychological support in real time, when suffering arises. The main goal of the study is to evaluate the efficacy of CUIDA-TE to improve emotion regulation in healthcare workers, a population that has been particularly emotionally impacted by the COVID-19 pandemic. Methods: In this three-arm, randomized controlled trial (RCT) the study sample will be composed of a minimum of 174 healthcare workers. They will be randomly assigned to a 2-month EMI group (CUIDA-TE APP, n = 58), a 2-month ecological momentary assessment (EMA) only group (MONITOR EMOCIONAL APP, n = 58), or a wait-list control group (no daily monitoring nor intervention, n = 58). CUIDA-TE will provide EMI if EMA reveals emotional problems, poor sleep quality/quantity, burnout, stress, or low perceived self-efficacy when regulating emotions. Depression will be the primary outcome. Secondary outcomes will include emotion regulation, quality of life, and resilience. Treatment acceptance and usability will also be measured. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at the 3-month follow-up for all groups. Discussion: To our knowledge, this is the first RCT that evaluates the efficacy of an APP-based EMI to improve emotion regulation skills in healthcare workers. This type of intervention might ultimately help disseminate treatments and reach a larger number of individuals than traditional face-to-face individual therapies. Trial registration: ClinicalTrial.gov: NCT04958941 Registered 7 Jun 2021. Study status: Participant recruitment has not started

Blended transdiagnostic group CBT for emotional disorders: a feasibility trial protocol

Emotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial

Efficacy of “Family Connections”, a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial

Background: Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients’ recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants’ acceptance). This paper presents the study protocol. Methods: The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants’ treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed. Discussion: This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives’ and patients’ data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.Funding for the study was provided by grants: the Ministry of Innovation, Universities, Science and Digital Society (Generalitat Valenciana): I + D + I projects developed by Emerging groups. GV/2019/148 has been awarded to VG as the main investigator of the project and PhD grant has been awarded to IF-F from the Ministry of Education, Culture and Sport (FPU) (FPU17/04210) to produce a doctoral thesis. The study protocol was reviewed by the Generalitat Valenciana: the Ministry of Innovation, Universities, Science and Digital Society. Call for papers: Emerging research groups

Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies

Background: there are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. Methods: the current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. Discussion: to the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them

mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study

Attempts to optimize monitoring of brace adherence prescribed to adolescents with idiopathic scoliosis (IS) have generally relied on sensors. Sensors, however, are intrusive and do not allow the assessment of psychological and physical consequences of brace use that might underlie poor adherence. Mobile applications have emerged as alternatives to monitor brace compliance. However, the feasibility and utility of these app-based systems to assess key psychological and physical domains associated with non-adherence remain unexplored. This feasibility study aims to test the usability, acceptability, and clinical utility of an app-based system that monitors brace use and related psychological and physical factors. Forty adolescents with IS daily respond to the app for 90 days. The patient responses may generate clinical alarms (e.g., brace non-adherence, discomfort, or distress) that will be sent daily to the medical team. Primary outcomes will be app usability, acceptability, and response rates. Secondary outcomes will include brace adherence, the number of side effects reported, number and type of clinical alarms, stress, quality of life, perceived health status, and mood. If accepted by patients and clinicians, apps may allow rapid detection and response to undesired events in adolescents undergoing brace treatment