Efficacy and Acceptability of Remote Cognitive Behavioral Therapy for Patients With Major Depressive Disorder in Japanese Clinical Settings: A Case Series.

Remote cognitive and behavioral therapy (CBT) via videoconference has been garnering attention as a means of improving access to CBT for depression, in particular during the coronavirus disease 2019 pandemic. However, there is a lack of evidence supporting its implementation in Japanese clinical settings. This case series aimed to establish preliminary evidence of whether remote CBT can be an effective therapy for major depression in Japanese clinical settings. Five patients who met the diagnostic criteria for major depressive disorder were enrolled and underwent remote CBT via videoconference and face-to-face assessment interviews. The results showed that remote CBT via videoconference improved depressive symptoms, enabling a relatively high level of patient satisfaction and working alliance. Moreover, detailed feedback from our patients showed that continuous monitoring was preferable for increasing treatment engagement. Further research is warranted to test the efficacy and acceptability of remote CBT via videoconference for treating major depression.

Aligning the many definitions of treatment resistance in anxiety disorders: A systematic review.

Anxiety Disorders often show a chronic course, even when treated with one of the various effective treatments available. Lack of treatment effect could be due to Treatment Resistance (TR). Consensus on a definition for TR Anxiety Disorders (TR-AD) is highly needed as currently many different operationalizations are in use. Therefore, generalizability in current TR-AD research is suboptimal, hampering improvement of clinical care. The objective of this review is to evaluate the currently used definitions of TR-AD by performing a systematic review of available literature. Out of a total of n = 13 042, 62 studies that operationalized TR-AD were included. The current review confirms a lack of consensus on TR-AD criteria. In 62.9% of the definitions, TR was deemed present after the first treatment failure. Most studies (93.0%) required pharmacological treatment failures, whereas few (29.0%) required psychological treatment failures. However, criteria for what constitutes "treatment failure" were not provided in the majority of studies (58.1%). Definitions for minimal treatment duration ranged from at least 4 weeks to at least 6 months. Almost half of the TR-AD definitions (46.8%) required elevated anxiety severity levels in TR-AD. After synthesis of the results, the consensus definition considers TR-AD present after both at least one first-line pharmacological and one psychological treatment failure, provided for an adequate duration (at least 8 weeks) with anxiety severity remaining above a specified threshold. This definition could contribute to improving course prediction and identifying more targeted treatment options for the highly burdened subgroup of TR-AD patients.

Ecological momentary interventions for depression and anxiety.

Ecological momentary interventions (EMIs) are becoming more popular and more powerful resources for the treatment and prevention of depression and anxiety due to advances in technological capacity and analytic sophistication. Previous work has demonstrated that EMIs can be effective at reducing symptoms of depression and anxiety as well as related outcomes of stress and at increasing positive psychological functioning. In this review, we highlight the differences between EMIs and other forms of treatment due to the nature of EMIs to be deeply integrated into the fabric of people's day-to-day lives. EMIs require unique considerations in their design, deployment, and evaluation. Furthermore, given that EMIs have been advanced by changes in technologies and that the use of behavioral intervention technologies for mental health has been increasing, we discuss how technologies and analytics might usher in a new era of EMIs. Future EMIs might reduce user burden and increase intervention personalization and sophistication by leveraging digital sensors and advances in natural language processing and machine learning. Thus, although current EMIs are effective, the EMIs of the future might be more engaging, responsive, and adaptable to different people and different contexts.

Aerobic exercise training facilitates the effectiveness of cognitive behavioral therapy in panic disorder.

BACKGROUND: Physical activity has been discussed as a therapeutic alternative or add-on for the treatment of anxiety disorders. We studied whether aerobic exercise compared to physical activity with low impact can improve the effect of cognitive behavioral therapy (CBT) in patients with panic disorder (PD) with/without agoraphobia. METHODS: Forty-seven patients received group CBT treatment over 1 month, which was augmented with an 8-week protocol of either aerobic exercise (three times/week, 30 min, 70% VO(2) max; n = 24) or a training program including exercises with very low intensity (n = 23) in a randomized controlled double-blind design. The primary outcome measure was the total score on the Hamilton Anxiety Scale (Ham-A). A 2 × 3 analysis of covariance (ANCOVA) with baseline value as a covariate was conducted for data analysis. RESULTS: Time × group interaction for the Ham-A revealed a significant effect (P = .047, η(2) p = .072), which represented the significant group difference at a 7-month follow-up. For the other clinical outcome measures no statistical significance emerged, although improvement was more sustained in the exercise group. CONCLUSIONS: For patients with PD, regular aerobic exercise adds an additional benefit to CBT. This supports previous results and provides evidence about the intensity of exercise that needs to be performed.

Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study.

BACKGROUND: Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes. Rural caregivers are particularly vulnerable but have limited access to cognitive behavioral therapy for insomnia (CBT-I), a recommended frontline treatment for chronic insomnia. Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments. Our team translated an efficacious 4-session standard CBT-I content protocol into digital format to create NiteCAPP. OBJECTIVE: This study aimed to (1) adapt NiteCAPP for dementia caregivers to create NiteCAPP CARES, a tailored digital format with standard CBT-I content plus caregiver-focused modifications; (2) conduct usability testing and evaluate acceptability of NiteCAPP CARES' content and features; and (3) pilot-test the adapted intervention to evaluate feasibility and preliminary effects on sleep and related health outcomes. METHODS: We followed Medical Research Council recommendations for evaluating complex medical interventions to explore user needs and adapt and validate content using a stepwise approach: (1) a rural dementia caregiver (n=5) and primary care provider (n=5) advisory panel gave feedback that was used to adapt NiteCAPP; (2) caregiver (n=5) and primary care provider (n=7) focus groups reviewed the newly adapted NiteCAPP CARES and provided feedback that guided further adaptations; and (3) NiteCAPP CARES was pilot-tested in caregivers (n=5) for feasibility and to establish preliminary effects. Self-report usability measures were collected following intervention. Before and after treatment, 14 daily electronic sleep diaries and questionnaires were collected to evaluate arousal, health, mood, burden, subjective cognition, and interpersonal processes. RESULTS: The stepped approach provided user and expert feedback on satisfaction, usefulness, and content, resulting in a new digital CBT-I tailored for rural dementia caregivers: NiteCAPP CARES. The advisory panel recommended streamlining content, eliminating jargon, and including caregiver-focused content. Focus groups gave NiteCAPP CARES high usefulness ratings (mean score 4.4, SD 0.79, scored from 1=least to 5=most favorable; score range 4.2-4.8). Multiple features were evaluated positively, including the intervention's comprehensive and engaging information, caregiver focus, good layout, easy-to-access intervention material, and easy-to-understand sleep graphs. Suggestions for improvement included the provision of day and night viewing options, collapsible text, font size options, tabbed access to videos, and a glossary of terms. Pilot-test users rated usefulness (mean score 4.3, SD 0.83; range 4.1-4.5) and satisfaction (mean score 8.4, SD 1.41, scored from 1=least to 10=most satisfied; range 7.4-9.0) highly. Preliminary effects on caregiver sleep, arousal, health, mood, burden, cognition, and interpersonal processes (all P<.05) were promising. CONCLUSIONS: Adaptations made to standard digital CBT-I created a feasible, tailored digital intervention for rural dementia caregivers. Important next steps include further examination of feasibility and efficacy in a randomized controlled trial with an active control condition, a multisite effectiveness trial, and eventual broad dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04632628; https://clinicaltrials.gov/ct2/show/NCT04632628.

A bibliometric analysis of research on heart failure comorbid with depression from 2002 to 2021.

Heart failure (HF) with depression is a common comorbidity associated with worse clinical status and quality of life. Although there have been numerous high-quality studies and relevant reviews on HF comorbid with depression, few bibliometric analyses of this field have been reported. In order to understand the development process, research hotspots and future directions, this review analyzes the papers on HF comorbid with depression from January 2002 to December 2021 through CiteSpace and VOSviewer. Visual cooperative networks between countries, authors and institutions were conducted to understand the basic development status of HF comorbid with depression. Furthermore, we performed co-occurrence analysis, burst detection, and timeline analysis for keywords to understand this field's research directions and hotspots. Finally, a detailed review and analysis of the classical literature in this field were conducted based on co-citation analysis. This bibliometric analysis provides an overview of studies on HF comorbid with depression and emphasizes the research on comorbidity mechanisms and more effective interventions as a priority for future research.

Substance use treatment using cultural arts and 12 steps: Curriculum training and community-led implementation in Zambia.

Introduction: Substance use in Zambia is stigmatized and treatment access is limited. Over 30,000 people are homeless in Lusaka, where one-quarter of homeless youth report use. Zambia's Ministry of Health recently developed policies targeting alcohol, suggesting Chainama, the only mental health hospital, offer treatment. Together, they endorsed training in the curriculum studied in this paper. We hypothesized training Zambian professionals would improve their perceptions of substance users and treatment. We then explored if treatment using the curriculum, as delivered to clients by training participants, would encourage client motivation to change, participation in groups, and reduce substance use frequency. Methods: Part 1: One-hundred professionals were trained in a curriculum-based, literacy-free intervention employing cognitive behavioral and rational emotive behavior therapy techniques to explore 12 Steps of addiction recovery through Zambian art forms. Pre/post questionnaires captured perspectives around substance users and treatment. Part 2: Trained organizations delivered the curriculum in their communities. Twenty-five organizations rated feasibility and benefit of the curriculum. Data for 200 clients recorded pre/post motivation to change, open-sharing/participation, and frequency of substance use. Results: While training significantly modified professionals' perspectives regarding the value of offering treatment, their views of substance users did not change. Clients endorsed increases in "motivation to change" and "participation/open-sharing." Frequency of alcohol, marijuana, inhalant, and cigarette use significantly decreased. Conclusion: Training in the curriculum helped address a public health need, playing a role in increased motivational variables and decreased substance use. Research addressing this study's limitations is encouraged. Video abstract: For a video summary of this paper, please visit https://youtu.be/uDZTVxtzF1Y.

Using smartphone-based ecological momentary assessment and personalized feedback for patients with chronic cancer-related fatigue: A proof-of-concept study.

Introduction: Chronic cancer-related fatigue (CCRF) is a complex multidimensional problem warranting person-centered care. Providing patients and therapists personalized feedback based on network analysis applied to ecological momentary assessment (EMA) data could facilitate case conceptualization in psycho-oncological care. The aim was to explore patients' and therapists' experiences of using an EMA app and personalized feedback based on network theory to aid case conceptualization in psycho-oncological care. Methods: A n = 5 proof-of-concept study was implemented in routine psycho-oncological care. We purposively selected adult cancer patients suffering from severe CCRF who were on the waitlist for psycho-oncological care. During a 3-week period participants filled out the EMA app Energy InSight (fatigue, mood, activity, responding, and context) five times a day. Participants received a descriptive and network feedback report, which they reflected upon during the first therapy sessions. Thematic analysis was used to analyze user experiences. Results: Patients experienced that filling out the Energy InSight app, as well as receiving descriptive and network-based personalized feedback provided them with insight into their CCRF. Although therapists experienced the discussion of network feedback as challenging, it facilitated the case conceptualization. Discussion: Using EMA during waitlist for psychological care seemed feasible. Patients experienced beneficial effects from filling out the EMA app and talking over the personalized feedback reports, which in turn aided case conceptualization and personalized care. Based on this evaluation, an improved version of the Energy InSight app and a therapist training for providing network feedback is developed for implementation in psycho-oncological care.

Using AI chatbots to provide self-help depression interventions for university students: A randomized trial of effectiveness.

BACKGROUND: Depression impacts the lives of a large number of university students. Mobile-based therapy chatbots are increasingly being used to help young adults who suffer from depression. However, previous trials have short follow-up periods. Evidence of effectiveness in pragmatic conditions are still in lack. OBJECTIVE: This study aimed to compare chatbot therapy to bibliotherapy, which is a widely accepted and proven-useful self-help psychological intervention. The main objective of this study is to add to the evidence of effectiveness for chatbot therapy as a convenient, affordable, interactive self-help intervention for depression. METHODS: An unblinded randomized controlled trial with 83 university students was conducted. The participants were randomly assigned to either a chatbot test group (n = 41) to receive a newly developed chatbot-delivered intervention, or a bibliotherapy control group (n = 42) to receive a minimal level of bibliotherapy. A set of questionnaires was implemented as measurements of clinical variables at baseline and every 4 weeks for a period of 16 weeks, which included the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder scale (GAD-7), the Positive and Negative Affect Scale (PANAS). The Client Satisfaction Questionnaire-8 (CSQ-8) and the Working Alliance Inventory-Short Revised (WAI-SR) were used to measure satisfaction and therapeutic alliance after the intervention. Participants' self-reported adherence and feedback on the therapy chatbot were also collected. RESULTS: Participants were all university students (undergraduate students (n = 31), postgraduate students (n = 52)). They were between 19 and 28 years old (mean = 23.08, standard deviation (SD) = 1.76) and 55.42% (46/83) female. 24.07% (20/83) participants were lost to follow-up. No significant group difference was found at baseline. In the intention-to-treat analysis, individuals in the chatbot test group showed a significant reduction in the PHQ-9 scores (F = 22.89; P < 0.01) and the GAD-7 scores (F = 5.37; P = 0.02). Follow-up analysis of completers suggested that the reduction of anxiety was significant only in the first 4 weeks. The WAI-SR scores in the chatbot group were higher compared to the bibliotherapy group (t = 7.29; P < 0.01). User feedback showed that process factors were more influential than the content factors. CONCLUSIONS: The chatbot-delivered self-help depression intervention was proven to be superior to the minimal level of bibliotherapy in terms of reduction on depression, anxiety, and therapeutic alliance achieved with participants.

The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy.

Background: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown. Methods: We conducted a post-hoc analysis of four phase III, randomized, double-blind, placebo-controlled, 56-week studies (COR-I, COR-II, COR-BMOD, and COR-DM), the placebo-controlled cardiovascular outcomes trial LIGHT (208 weeks), and the randomized, open-label trial IGNITE (78 weeks). Included subjects were treated with NB 32 mg/360 mg or placebo, with baseline, week 16, and final time point data. The primary outcome was Kaplan-Meier-estimated weight loss maintenance in each study for up to 204 weeks. Findings: Our analysis included data from 10,198 particpants (NB=5412; placebo=4786). Proportions of patients with ≥5% or ≥10% weight loss maintenance were numerically higher for NB vs. placebo in all studies and time points. Differences were statistically significant for ≥5% weight loss maintenance in COR-BMOD and COR-I/-II at weeks 52 and 56 and the LIGHT study at weeks 52, 104, and 208. For ≥10% weight loss maintenance, differences were statistically significant in COR-I/COR-II at weeks 52 and 56. Interpretation: These data suggest that NB could be used as part of long-term, comprehensive weight loss and weight loss maintenance strategies. Funding: Orexigen Therapeutics, Inc. and Bausch Health Canada.

The relationship between anxiety sensitivity and clinical outcomes in cardiac rehabilitation: A scoping review.

Background: Despite well-established efficacy for patients with a cardiovascular diagnosis or event, exercise-based cardiac rehabilitation program participation and completion has remained alarmingly low due to both system-level barriers and patient-level factors. Patient mental health, particularly depression, is now recognized as significantly associated with reduced enrollment, participation, attendance, and completion of a cardiac rehabilitation program. More recently, anxiety sensitivity has emerged as an independent construct, related to but distinct from both depression and anxiety. Anxiety sensitivity has been reported to be adversely associated with participation in exercise and, thus, may be important for patients in cardiac rehabilitation. Accordingly, the objective of this study was to conduct a scoping review to summarize the evidence for associations between anxiety sensitivity and cardiovascular disease risk factors, exercise, and clinical outcomes in cardiac rehabilitation. Methods: A formal scoping review, following PRISMA-ScR guidelines, was undertaken. Searches of MEDLINE, Web of Science, CINAHL, PSYCINFO, and Scopus databases were conducted, supplemented by hand searches; studies published through December of 2020 were included. The initial screening was based on titles and abstracts and the second stage of screening was based on full text examination. Results: The final search results included 28 studies. Studies reported statistically significant associations between anxiety sensitivity and exercise, cardiovascular disease, and participation in cardiac rehabilitation. Many studies, however, were conducted in non-clinical, community-based populations; there were few studies conducted in cardiovascular disease and cardiac rehabilitation clinical patient populations. Additionally, significant gaps remain in our understanding of the sex-based differences in the complex relationships between anxiety sensitivity, exercise and cardiac rehabilitation. Conclusion: More research is needed to understand specific associations between anxiety sensitivity and clinical outcomes among clinical cardiovascular disease patients and participants in cardiac rehabilitation programs. Treatment of anxiety sensitivity to optimize clinical outcomes in cardiac rehabilitation programs should be investigated in future studies.

Economic evaluation alongside a randomized controlled trial of blended cognitive-behavioral therapy for patients suffering from major depressive disorder.

OBJECTIVE: This study aimed to investigate the cost-effectiveness of blended cognitive-behavioral therapy (CBT) compared to standard CBT for adult patients suffering from major depressive disorder (MDD). DESIGN: A cost-utility analysis alongside the randomized controlled ENTER trial. SETTING: Center for Telepsychiatry, Mental Health Services in the Region of Southern Denmark, Denmark. PARTICIPANTS: The study included 76 patients suffering from MDD. INTERVENTIONS: The patients in the intervention group received blended CBT treatment comprising a combination of online modules and face-to-face consultations with a psychologist. The patients in the control group received standard CBT treatment, that is, solely face-to-face consultations with a psychologist. The treatment period was 12 weeks. OUTCOME MEASURES: Cost-effectiveness was reported as incremental cost-effectiveness ratio. A micro-costing approach was applied to evaluate the savings derived. Changes in quality-adjusted life-years (QALYs) were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at the baseline and the six-month follow-up. RESULTS: Data for 74 patients were included in the primary analysis. The adjusted QALY difference between blended CBT and standard CBT was -0.0291 (95% CI: -0.0535 to -0.0047), and the adjusted difference in costs was -£226.32 (95% CI: -300.86 to -151.77). Blended CBT was estimated to have a 6.6% and 3.1% probability of being cost-effective based on thresholds of £20,000 and £30,000. CONCLUSION: Compared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD. However, results should be carefully interpreted, given the small sample size. Future research involving larger replication studies focusing on other aspects of blended CBT with more patient involvement is advised. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: S-20150150.

Disorder-specific internet-based cognitive-behavioral therapy in treating panic disorder, comorbid symptoms and improving quality of life: A meta-analytic evaluation of randomized controlled trials.

Compared to conventional face-to-face psychological treatments, internet-based cognitive-behavioral therapy (iCBT) presents an innovative alternative that has been found to be effective in the treatment of anxiety disorders. The current study provides a meta-analysis investigating the efficacy of disorder-specific guided self-help (Gsh) iCBT compared to various active and inactive control conditions, with focus on adult panic disorder sufferers with or without agoraphobia (PD/A). Systematic literature search yielded 13 randomized controlled trials (RCTs) (N = 1214) that met the eligibility criteria for this study. We found no statistically significant differences between Gsh iCBT and various active CBT interventions in reducing PD/A symptoms at both post-test (g = 0.015, k = 10) and follow-up (g = 0.113, k = 6) levels. Also, comorbid anxiety and depression were reduced equivalently at post-test (g = 0.004, k = 6) and follow-up (g = 0.004, k = 6). Quality of life was equally improved at post-test (g = -0.100, k = 5) and follow-up (g = 0.074, k = 2). When compared to inactive controls, we found large effect sizes in PD/A (g = -0.892, k = 9) and comorbid anxiety and depression (g = -0.723, k = 9) symptoms, and moderate change in quality of life (g = -0.484, k = 3) at post-test. There was no difference between Guided self-help iCBT and Self-help iCBT in PD/A (g = -0.025, k = 3) and comorbid anxiety and depression (g = -0.025, k = 3) at post-test. Baseline severity, country of original research and adherence to the treatment in form of initial uptake were identified as statistically significant moderators of the iCBT treatment.

Dismantling internet-based cognitive behavioral therapy for tinnitus. The contribution of applied relaxation: A randomized controlled trial.

BACKGROUND: Internet-based cognitive behavioral therapy (ICBT) for tinnitus is an evidence-based intervention. The components of ICBT for tinnitus have, however, not been dismantled and thus the effectiveness of the different therapeutic components is unknown. It is, furthermore, not known if heterogeneous tinnitus subgroups respond differently to ICBT. AIMS: This dismantling study aimed to explore the contribution of applied relaxation within ICBT for reducing tinnitus distress and comorbidities associated with tinnitus. A secondary aim was to assess whether outcomes varied for three tinnitus subgroups, namely those with significant tinnitus severity, those with low tinnitus severity, and those with significant depression. METHODS: A parallel randomized controlled trial design (n = 126) was used to compare audiologist-guided applied relaxation with the full ICBT intervention. Recruitment was online and via the intervention platform. Assessments were completed at four-time points including a 2-month follow-up period. The primary outcome was tinnitus severity as measured by the Tinnitus Functional Index. Secondary outcomes were included for anxiety, depression, insomnia, negative tinnitus cognitions, health-related quality of life, hearing disability, and hyperacusis. Treatment engagement variables including the number of logins, number of modules opened, and the number of messages sent. Both an intention-to-treat analysis and completer's only analysis were undertaken. RESULTS: Engagement was low which compromised results as the full intervention was undertaken by few participants. Both the ICBT and applied relaxation resulted in large reduction of tinnitus severity (within-group effect sizes d = 0.87 and 0.68, respectively for completers only analysis), which were maintained, or further improved at follow-up. These reductions in tinnitus distress were greater for the ICBT group, with a small effect size differences (between-group d = 0.15 in favor of ICBT for completers only analysis). Tinnitus distress decreased the most at post-intervention for those with significant depression at baseline. Both ICBT and applied relaxation contributed to significant reductions on most secondary outcome measures, with no group differences, except for a greater reduction of hyperacusis in the ICBT group. CONCLUSION: Due to poor compliance partly attributed to the COVID-19 pandemic results were compromised. Further studies employing strategies to improve compliance and engagement are required. The intervention's effectiveness increased with initial level of tinnitus distress; those with the highest scores at intake experienced the most substantial changes on the outcome measures. This may suggest tailoring of interventions according to tinnitus severity. Larger samples are needed to confirm this.

Post-Acute COVID-19 Syndrome and the cardiovascular system: What is known?

Post-Acute COVID-19 Syndrome (PACS) is defined by persistent symptoms >3-4 weeks after onset of COVID-19. The mechanism of these persistent symptoms is distinct from acute COVID-19 although not completely understood despite the high incidence of PACS. Cardiovascular symptoms such as chest pain and palpitations commonly occur in PACS, but the underlying cause of symptoms is infrequently known. While autopsy studies have shown that the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) rarely causes direct myocardial injury, several syndromes such as myocarditis, pericarditis, and Postural Orthostatic Tachycardia Syndrome have been implicated in PACS. Additionally, patients hospitalized with acute COVID-19 who display biomarker evidence of myocardial injury may have underlying coronary artery disease revealed by the physiological stress of SARS-CoV-2 infection and may benefit from medical optimization. We review what is known about PACS and the cardiovascular system and propose a framework for evaluation and management of related symptoms.

Internet-based cognitive behavioral therapy for psychological distress in older adults without cognitive impairment living in nursing homes during the COVID-19 pandemic: A feasibility study.

BACKGROUND: The COVID-19 pandemic has had a detrimental effect on the mental health of older adults living in nursing homes. Very few studies have examined the effects of Internet-based Cognitive Behavioral Therapy (ICBT) on older adults living in nursing homes during the pandemic. We conducted a feasibility study using a single-group design, to explore the effectiveness of ICBT on psychological distress in 137 older adults (without cognitive impairment) from 8 nursing homes in 4 southeast cities in China, between January and March 2020. METHODS: Symptoms of depression, anxiety, general psychological distress, and functional disability were measured at baseline, post-treatment (5 weeks) and at a 1-month follow-up. Mixed-effects model was used to assess the effects of ICBT. RESULTS: Statistically significant changes with large effect sizes were observed from pre- to post-treatment on the PHQ-9 (p < .001, Cohen's d = 1.74), GAD-7 (p < .001, d = 1.71), GDS (p < .001, d = 1.30), K-10 (p < .001, d = 1.93), and SDS (p < .001, d = 2.03). Furthermore, improvements in treatment outcomes were sustained at 1-month follow-up, and high levels of adherence and satisfaction were indicated. CONCLUSION: ICBT was effective in reducing psychological distress in older adults without cognitive impairments living in nursing homes during the COVID-19 pandemic. Thus, it could be applied in improving the mental health of this vulnerable group during the pandemic.

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD).

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms. METHODS: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time. RESULTS: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05). CONCLUSION: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial.

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help. TRIAL REGISTRATION: Clinicaltrials.gov as NCT04074681. Registered 22 July 2019.

Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache.

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.

Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocol.

Background: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however ~30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions. Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naïve, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG. Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naïve, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities). Trial Registration: This study is registered with the United States National Library of Medicine Clinical Trials Registry (NCT03548545). Registered June 7, 2018, clinicaltrials.gov/ct2/show/NCT03548545. Protocol Version 1.