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CONTEXT/OBJECTIVE: In-person hypnotic cognitive therapy (HYP-CT) is a promising treatment for chronic spinal cord injury-related pain. We describe the effects of HYP-CT delivered via Zoom (Z-HYP-CT) and compare the effects to historical controls who received hypnosis, cognitive therapy, or HYP-CT in-person. DESIGN: Open pilot trial of HYP-CT versus historical controls. SETTING: Telehealth study that recruited people with chronic SCI. PARTICIPANTS: Adults with moderate to severe chronic SCI-related pain. INTERVENTIONS: Four weekly sessions of HYP-CT delivered via Zoom. OUTCOME MEASURES: The primary outcome was average pain intensity on a 0-10 numerical rating scale measured at end of treatment (4 weeks) and 12 weeks. Secondary outcomes included pain interference, depression, sleep, pain catastrophizing, and pain self-efficacy. RESULTS: 23 individuals with SCI-related pain participated in the open trial and were compared to 21 historical controls. Average age was 54 years, 70% were male, and the majority were White. The participants were 11.6-13.1 years post-SCI and average pain intensity was 4.8-5.4/10. After Z-HYP-CT mixed-effects linear regressions showed that pain intensity was significantly less at 4 weeks (-1.28, P < .0001) and 12 weeks (-1.50, P < .0001) relative to baseline. Pain interference, depression, and pain catastrophizing also decreased significantly at both time points. There were no significant differences between the effects of Z-HYP-CT versus historical controls on any outcome variable. CONCLUSION: HYP-CT delivered via telehealth was associated with reduced pain intensity and other benefits that were comparable to the effect achieved by in-person historical controls. The effects of Z-HYP-CT should be evaluated using a randomized controlled design.

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Depressive disorders are an enormous societal burden given their high prevalence and impact on all facets of being human (e.g., relationships, emotions, motivation). There is a variety of evidence-based psychological treatments, with cognitive behavioral therapy (CBT) being the gold standard for major depression. Research has shown that mindfulness-based interventions (MBIs) such as mindfulness-based cognitive therapy (MBCT) are an effective relapse prevention and treatment for depression and that MBIs can be integrated in individual therapy. Furthermore, various delivery modes (e.g., digital-delivered therapy) and settings are offered to best meet different needs and improve accessibility: Evidence suggests that therapist-guided digital CBT, blended therapy, and, to some degree, digitalized MBIs may be an efficacious supplement to traditional face-to-face therapy. This chapter provides an overview of the principles and evidence base for CBT and MBCT as well as different delivery modes for depressive disorders in adults. Finally, chances and challenges of integration are discussed as implications for practice, as well as recommendations and ideas for future research.

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BACKGROUND: Mental health disorders still rank as leading causes of morbidity worldwide despite increasing awareness and improvements in treatment. Notably, low- and middle-income countries like Uganda, are disproportionately affected by such disorders. The burden of depressive symptoms in these countries is particularly high among students, aggravated by poverty, malnutrition, and inadequate public health governance, yet it is clearly under-researched, making it hard to achieve several of UN Sustainability Development Goals. Current treatment options are insufficient to tackle the increased burden of depressive disease. This is more challenging for low-resource regions especially in Sub-Saharan Africa, suggesting the need for alternative treatments that can swiftly be applied if proven effective. The main aim of this randomized controlled trial (RCT) is therefore to examine if a low-cost healthy diet (based on local Ugandan foods) combined with easy-to access mindfulness cognitive therapy can reduce depressive symptoms among university students in Uganda. METHODS: We will recruit female and male students at Makerere University, the largest public university in Uganda, to an open, intention-to-treat, two-armed RCT. Those who score above a predefined threshold on a self-reported assessment of depressive symptoms, measured by the Center for Epidemiological Studies - Depression score (CES-D), are eligible for study inclusion and will be randomized to either an intervention (n = 125) or a control (n = 125) group. The intervention group will receive educational group-based sessions on how to prepare a Mediterranean-type of healthy diet and how to adhere to the principles of mindfulness-based cognitive therapy. Outcome measures include self-reported depression symptoms, quality of life, and dietary intakes. In addition we will perform a cost-effectiveness analysis. The RCT intervention will last 9 months, followed by additional 15 months with regular data collections. DISCUSSION: We here describe a novel approach to treat depressive symptoms among university students living in resource constraint settings, by combining a healthy diet with low threshold psychotherapy. If this intervention succeeds, our project can be viewed as a step towards evidence-based behavior practices for young adults with a common mental disorder (depression) that are beneficial to public mental health initiatives and management. TRIAL REGISTRATION: The RCT is registered in ClinicalTrials.gov (ID: NCT05848973). The date of registration was August 14, 2023.

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Introduction: Pain is a complex phenomenon influenced by psychosocial variables, including the placebo effect. The effectiveness of mindfulness-based interventions (MBIs) for pain has been demonstrated in experimental studies and systematic reviews, but the mechanisms of action are only starting to be established. Whether the expectations of individuals experiencing pain can be manipulated during MBIs remains to be systematically evaluated, and what role placebo effects might play remains to be explored. Methods: To evaluate the literature analyzing placebo effects in MBIs for pain, we performed a systematic review based on searches conducted in PubMed, Web of Science, and SCOPUS databases. Our search revealed a total of 272 studies, of which only 19 studies were included (10 acute pain and nine chronic pain), considering the inclusion and exclusion criteria related to expectations and placebo effects. Results: From the 19 included studies, six measured placebo effects only in relation to the pharmacological intervention used in the study and not to an MBI. Discussion: The results of the few studies that focused on the placebo effects of the MBIs indicate that placebo and expectations play a role in the MBIs' effects on pain. Although expectations and placebo effects are frequently discussed in the context of mindfulness and pain research, these results show that these factors are still not routinely considered in experimental designs. However, the results of the few studies included in this systematic review highlight a clear role for placebo and expectancy effects in the overall effects of MBIs for both acute and chronic pain, suggesting that routine measurement and further consideration in future studies are warranted. Additional research in this fascinating and challenging field is necessary to fully understand the connection between MBIs, placebo/expectations, and their effects on pain relief.

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BACKGROUND: Mindfulness-based cognitive therapy (MBCT) includes regular home practice of mindfulness exercises as a key means of cultivating mindfulness. Although there are instruments available for measuring homework adherence following cognitive behavioral therapy (CBT), little is known about measuring homework practice in MBCT studies for sexual dysfunction. AIM: In this review we sought to investigate which items and instruments are the most used for the assessment of homework adherence in studies evaluating MBCT for the treatment of female sexual dysfunction (FSD). We also investigated the types of homework used in these interventions. METHODS: Five databases (PubMed, Scopus, PsycINFO, Embase, and Web of Science) were searched and a total of 30 articles were included in this review. OUTCOMES: Our main findings revealed that there was no gold standard instrument used to assess homework adherence in patients using MBCT interventions for FSD, and that most of the reported studies did not provide information on how they assess homework adherence. RESULTS: Six of the 9 studies for which the articles reported how homework was assessed used only ad hoc measures. Only 3 studies used psychometrically validated instruments. We also found that mindfulness, psychoeducation, and CBT exercises were the most prescribed homework. STRENGTHS AND LIMITATIONS: This review uniquely integrates homework adherence measures with studies on FSD that evaluate mindfulness, finding no gold standard for assessing adherence. However, limitations including both MBCT and CBT interventions, limiting generalization to MBCT alone, the predominance of Western-based studies, and the lack of reporting on instruments used to assess adherence, indicating a gap in the field. CONCLUSION: Further studies should consider adapting existing instruments that assess homework adherence in studies of CBT for other psychopathologies or seek to develop new psychometrically validated instruments for MBCT interventions that assess homework adherence.

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Background: The aim of the current pilot study was to evaluate the usability, acceptability, and tolerability of virtual reality (VR)-based cognitive stimulation exercises (CSEs) in healthy young versus old populations before health care integration. A secondary aim was to assess the accuracy of VR games as a proxy for cognitive stimulation, specifically for attention. VR-based CSEs promise to improve attention and brain function through varied learning systems. Methods: This is a Phase 1 feasibility clinical trial at a single center. It involves 30 healthy volunteers randomly selected using the American Society of Anesthesiologists (ASA) physical status classification system. Participants fall into ASA 1 (age >18-35 years, n = 15) or ASA 2 (age >60 years, n = 15) categories. All participants tested the ReCognitionVR-based CSEs. Feasibility criterion: Participants in each group were monitored for completion of 20 minutes of VR-based CSEs. Acceptability criterion: Proportion of participants with system usability scale (SUS) >35 or SUS score of 87.5. Safety (tolerability) monitoring: Sessions were monitored for neurological, cardiovascular, or pulmonary adverse events (AEs). Safety criterion: No more than 10% of sessions stopped due to neurological, cardiovascular, or pulmonary AEs. Results: The primary outcome (feasibility) of ReCognitionVR-based CSEs was 100%. For the secondary outcome (acceptability), there was no group difference in SUS scores (ASA 1 = 88.17 ± 12.83 vs. ASA 2 = 88.39 ± 10.22, P = 0.81). For the tertiary outcome (safety), mild transient uneasiness was reported by two (13.4%) ASA 1 participants (resolved in 2 minutes), and one (6.67%) ASA 1 participant experienced a temporary >20% increase in blood pressure from baseline. No ASA 2 participants had AEs. Conclusion: The feasibility, acceptability, and safety of ReCognitionVR-based CSEs in healthy elderly volunteers are acceptable, indicating that the evaluation of the ReCognitionVR-based CSEs in hospitalized patients is reasonable.

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OBJECTIVE: To compare the effects of aromatherapy with lavender and mindfulness-based cognitive therapy for sexuality (MBCT-S) on female sexual function. DESIGN: Randomized controlled trial. SETTING: Health centers in Roudan city, Iran. PARTICIPANTS: Sixty married women, ages 18 to 45 years, were recruited using the Female Sexual Function Index (FSFI). Participants were selected from health centers in 2022 via convenience sampling. INTERVENTION AND MEASUREMENTS: Upon their completion of a demographic checklist and the FSFI as a pretest, participants were divided into three groups, including lavender aromatherapy (n = 20), MBCT-S (n = 20), and control (n = 20) through random selection with permutation blocks. All groups completed FSFI as a posttest. Data were analyzed by SPSS 26 using chi-square, Wilcoxon, Kruskal-Wallis, and Mann-Whitney statistical tests. RESULTS: There was no statistically significant difference among the three groups before the intervention (p = .652), but there was a significant difference among them after the intervention (p = .001). There was a significantly positive difference between the intervention groups and the control group (p < .001). A significant relationship was observed among the three groups in sexual desire, pain, satisfaction, lubrication, and arousal. The mean scores of the posttest in sexual desire, pain, satisfaction, and lubrication were positively higher in the MBCT-S group than in the aromatherapy group, and both intervention groups showed the same effect for sexual arousal. Aromatherapy and counseling had no significant effect on improving sexual orgasm. CONCLUSION: MBCT-S can be used to improve many aspects of female sexual function, except for orgasm disorders; aromatherapy may improve sexual arousal.

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The incidence of allergic rhinitis in children is high across the world, as well as in China. Allergic rhinitis in children has serious impact on physical and mental health of the children. At the same time, the caregivers of allergic rhinitis children have heavy burden of care, and their mental problems are severe. It is necessary to implement timely psychological intervention for the caregivers of allergic rhinitis children. Mindfulness-Based Cognitive Therapy (MBCT) is a safe and effective psychological therapy, and the effect of online intervention can be comparable to the traditional face-to-face intervention program. This study focused on the mental health status in the main caregivers of children with allergic rhinitis, and conducted a modified online MBCT intervention on the caregivers, in order to improve their adverse mental state, meanwhile, improve the quality of care they provide. The results show that online MBCT intervention is applicable to the main caregivers of children with allergic rhinitis, and can effectively reduce caregiver burden, relieve anxiety and depression, and improve the level of mindfulness in the caregivers.

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BACKGROUND: Cognitive therapy for social anxiety disorder (CT-SAD) has extensive empirical support and is recommended in several national guidelines. However, ensuring access to evidence-based psychological therapies such as CT-SAD remains a global challenge. An internet-delivered version of this treatment protocol (iCT-SAD) has recently been developed in the UK as a way to overcome this challenge, demonstrating comparable outcomes to face-to-face CT-SAD whilst requiring less therapist time per client. Initial findings also suggest its cross-cultural transferability, but the previous studies in other cultural settings used the English language programme and only included English-fluent participants as a second language. It is not yet known what outcomes can be achieved once the programme has been translated and adapted for a different cultural context. Therefore, this trial aims to evaluate the clinical efficacy of Japanese iCT-SAD when combined with treatment as usual (TAU) in clients with SAD. METHODS: This two-arm, parallel-group, superiority randomised controlled trial will recruit 60 Japanese participants with SAD, randomly assigning them to either Japanese iCT-SAD + TAU or TAU alone at a ratio of 1:1. The primary outcome measure is the self-report Liebowitz Social Anxiety Scale, and secondary.outcomes include other measures of social anxiety symptoms and processes, general mood and functioning, and response to treatment. We will also assess treatment acceptability and gather participant feedback. Assessments will take place at baseline (week 0), mid-treatment (week 8), and post-treatment (week 15), with a further 3-month follow-up (week 27) for the iCT-SAD + TAU arm. The primary analyses will be conducted on an intent-to-treat basis, comparing the primary and secondary outcome measures between groups using linear mixed-effect models, along with additional mediation analysis. DISCUSSION: Investigating the efficacy of translated and culturally adapted iCT-SAD in different cultural contexts is an important step in evaluating the global reach of internet interventions. This trial will provide valuable insights into the effects of iCT-SAD combined with usual care, and how this treatment could be delivered in routine clinical settings in Japan. TRIAL REGISTRATION: International Standard Randomized Controlled Trials (ISRCTN), ISRCTN82859645, registered on January 19, 2024. UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052702, registered on November 6, 2023.

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Introduction: Treatment-resistant depression (TRD) presents a significant challenge, affecting approximately 30% of individuals diagnosed with major depressive disorder and leading to poor treatment responses. Innovations in digital mental health, especially online mindfulness-based cognitive therapy (eMBCT), offer promising avenues for enhancing access to effective mental health care for individuals with TRD in a clinical setting. Objective: The aim of this study was to examine the feasibility of eMBCT in an individual clinical context to decrease depressive symptoms for TRD. Methods: Conducted at the Institute of Psychiatry of the Federal University of Rio de Janeiro, Brazil, this parallel-arm, randomized controlled feasibility trial involved outpatients diagnosed with TRD, aged 18 and above. Of the 39 outpatients invited, 28 were randomized into two groups: an intervention group receiving the eMBCT program (n = 15) and a control group (n = 13). The intervention, consisting of an 8-week course, was delivered via live video sessions. Following the assessment period, participants in the control group were offered the eMBCT intervention. Assessments using standardized questionnaires were conducted at the start and end of the study. Results: Within the eMBCT group, improvements were observed in depression symptoms (Z = -3.423; p = 0.001; effect size r = 0.78), anxiety symptoms (Z = -3.361; p = 0.001; effect size r = 0.77), with no significant changes in the control group. Comparatively, the eMBCT group showed significant reductions in depression symptoms and improvements in clinical global impressions over the control group (BDI2: U = 30.5; p = 0.015; effect size r = 0.47, CGI1: U = 21.0; p = 0.004; effect size r = 0.56). Conclusion: eMBCT in an individual format combined with medication, appears to be a feasible treatment for TRD, decreasing symptoms of depression. In a future trial the control group may have a manualized intervention. Clinical trial registration: The Brazilian Clinical Trials Registry: (https://ensaiosclinicos.gov.br/rg/RBR-6zndpbv) and RBR-6zndpbv.

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OBJECTIVES: Rates of PTSD are up to 12 times higher in care-experienced young people (CEYP) compared to their peers. Trauma-focused CBTs (tf-CBT) are the best-evidenced treatment for youth with PTSD, yet, in practice, CEYP often struggle to access this treatment. We worked alongside services to understand barriers and facilitators of the implementation of cognitive therapy for PTSD (a type of tf-CBT) to CEYP. DESIGN: This was an active, open implementation trial. METHODS: We recruited 28 mental health teams across England, including general CAMHS, targeted CAMHS for CEYP and social care-based teams. From these teams, participants were 243 mental health professionals, from a wide variety of professional backgrounds. Following recruitment/intervention training, teams participated in rolling three monthly focus groups and individual interviews, to understand what helped and hindered implementation. Data were analysed using a framework analysis conducted using CFIR 2.0. RESULTS: Almost half of the teams were able to implement, but only approximately one quarter with CEYP, specifically. Universal barriers that were discussed by almost all teams particularly highlighted service structures and poor resourcing as major barriers to delivery to CEYP, as well as the complexities of the young person and their network. Unique factors that differentiated teams who did and did not implement included commissioning practices, the culture of the team, leadership engagement and style, and the development of supervision structures. CONCLUSIONS: Findings offer key considerations for mental health teams, service leads, commissioners and policy-makers to enhance delivery of best-evidenced mental health treatments like CT-PTSD, for CEYP.

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Objective: The present study aimed to evaluate the efficacy of a mindfulness-based cognitive therapy (MBCT) intervention in reducing problematic mobile phone use, depression, and sleep disorders among adolescents. Additionally, it sought to investigate whether the decrease in problematic mobile phone use acted as a mediator in the relationship between the MBCT intervention and adolescent depression and sleep disorders. Methods: In a randomized controlled trial, a total of 104 adolescents were randomly assigned to the mindfulness group (n = 52) or the wait-list control group (n = 52). The mindfulness group students completed eight 45-min sessions of mindfulness training in four weeks. The outcomes were measured at baseline, postintervention, and at the 2-month follow-up. Results: Compared with the control group, the mindfulness group had significantly greater levels of mindfulness and lower levels of problematic mobile phone use, depression, and sleep disorders postintervention. The intervention effects were maintained at the 2-month follow-up. In addition, decreased problematic mobile phone use significantly mediated the association between the MBCT intervention and decreased depression and decreased sleep disorders. Conclusion: The findings suggest that MBCT could improve adolescent depression and sleep disorders and that decreasing problematic mobile phone use is an effective pathway accounting for the MBCT intervention effect on adolescent depression and sleep disorders.

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BACKGROUND AND AIM: To observe the clinical therapeutic effect and mental state of mindfulness-based cognitive therapy (MBCT) in patients with functional dyspepsia (FD). METHODS: In this study, 80 patients suffering from FD in an outpatient clinic were enrolled from January to December 2020. Patients were randomly allocated into the control group (conventional treatment) and observation group (MBCT treatment). Patients in the control group were prescribed rabeprazole and mosapiride, and patients in the observation group were given MBCT therapy in addition to the above drugs. After treatment for 8 weeks, the changes in gastrointestinal symptom scores, anxiety, depression, mindfulness and sleep quality and gastric emptying testing were compared between these two groups. RESULTS: The observation group showed strikingly lower gastrointestinal symptom scores, SAS, SDS, PSQI, and SCL-90 scale scores, and higher FFMQ scale scores than the control group (p < 0.05). There was no conspicuous change in gastric emptying monitoring (p > 0.05). CONCLUSIONS: MBCT therapy can improve patients' gastrointestinal symptoms, attenuate their anxiety and depression levels, and ameliorate their sleep quality.

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BACKGROUND: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. OBJECTIVE: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. METHODS: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. RESULTS: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. CONCLUSIONS: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT's efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53966.

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OBJECTIVE: Memory difficulties after brain injury are a frequent and concerning outcome, affecting a wide range of daily activities, employment, and social reintegration. Despite the importance of functional memory capacities throughout life, most studies examined the short-term effects of memory interventions in brain-damaged patients who underwent a rehabilitation program. In the present study, we investigated the long-term outcomes and intensity of memory interventions in acquired (traumatic brain injury [TBI] and non-TBI) brain-damaged patients who participated in an intensive cognitive rehabilitation program and either suffered or did not suffer from memory impairments. METHOD: We measured pre-post-treatment memory performance of patiients (N = 24) suffering from memory deficits in four common and validated memory tasks (e.g. ROCFT). We compared them to other acquired brain injury patients treated at the same rehabilitation facility who did not suffer from memory impairments (N = 16). RESULTS: Patients with memory deficits showed long-term improvements in three out of four tasks, while patients without memory deficits showed memory enhancements in only one task. In addition, rehabilitation intensity and type of brain damage predicted the extent of the memory change over time. DISCUSSION: Long-term improvements in objective memory measures can be observed in patients suffering from brain injury. These improvements can be enhanced by intensifying the treatment program. Findings also suggest that these memory improvements are more pronounced in non-TBI than TBI patients. We discuss the implications of these results in designing optimal memory rehabilitation interventions.

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Hikikomori (prolonged social withdrawal) has been discussed as a hidden worldwide epidemic and a significant social and healthcare issue. Social anxiety disorder is the most common psychiatric disorder preceding the onset of Hikikomori. Although studies exist suggesting the effectiveness of family-support interventions, little is known about psychotherapeutic approaches for Hikikomori individuals. Here, we present a case of Hikikomori wherein an internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) worked effectively in improving the client's social anxiety symptoms and social interaction behaviors. This case study demonstrates the principle that evidence-based psychological interventions focusing on social anxiety can be effective for clients with Hikikomori. Furthermore, the online mode of treatment delivery, along with a variety of relevant modules, may facilitate clients' engagement with treatment at home. The findings suggest that iCT-SAD might be a promising option for Hikikomori clients who have social anxiety problems, within the recommended stepped-intervention approach.

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BACKGROUND: People with Parkinson's disease (PD) are very sensitive to the effects of stress. The prevalence of stress-related neuropsychiatric symptoms is high, and acute stress worsens motor symptoms. Animal studies suggest that chronic stress may accelerate disease progression, but evidence for this in humans is lacking. Mindfulness-based interventions (MBIs) train participants to focus on the present moment, on purpose and without judgement. Previous studies suggest that MBIs may alleviate stress and reduce depression and anxiety in PD. We aim to demonstrate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) as a non-pharmacologic treatment strategy for neuropsychiatric (and motor) symptoms in PD, and to identify the mechanisms underlying stress and stress reduction in PD. METHODS: In a prospective randomized controlled trial (RCT), we investigate whether 8 weeks of MBCT, as compared to care as usual, can reduce symptoms of anxiety and depression in people with PD. We aim to include 124 PD patients, who experience mild-moderate symptoms of anxiety and depression, are eligible for magnetic resonance imaging (MRI) and naïve to mindfulness, and who have a disease duration ≤ 10 years. Every participant is followed for 12 months. Clinical and biochemical assessments take place at baseline (T0), after 2 months (T1), and after 12 months (T2); MRI assessments take place at T0 and T2. Our primary outcome is the total score on the Hospital Anxiety and Depression Scale (HADS) at T1, while correcting for the HADS score at T0, age, and gender. Beyond testing the effects of MBCT on symptoms of anxiety and depression in PD, we explore whether MBCT: (1) has an effect on motor symptom severity, (2) influences cerebral and biochemical markers of stress, and (3) leads to a change in biomarkers of PD progression. DISCUSSION: MIND-PD is one of the first RCTs with a 1-year follow-up to investigate the effects of MBCT on symptoms of anxiety and depression in PD, and to explore possible mechanisms underlying stress and stress reduction in PD. Insight into these mechanisms can pave the way to new treatment methods in the future. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05779137. Registered on 12 January 2023.

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BACKGROUND: Internet-based cognitive behavioral therapy (CBT) and stand-alone mindfulness meditation interventions are gaining empirical support for a wide variety of mental health conditions. In this study, we test the efficacy of web-based therapist-guided mindfulness-based cognitive behavioral therapy (CBT-M) for body dysmorphic disorder (BDD), a psychiatric disorder characterized by preoccupations with perceived defects in appearance. OBJECTIVE: This study aims to determine whether CBT-M for BDD delivered on the web is feasible and acceptable and whether mindfulness meditation adds to CBT treatment effects for BDD. METHODS: In this 8-week, 2-arm, parallel pilot randomized controlled trial, n=28 adults (aged between 18 and 55 years) were randomly allocated to an experimental group (web-based therapist-guided CBT-M) or a control group (web-based therapist-guided CBT). Study retention, accrual, and intervention adherence were assessed, along with self-report measures for BDD, depression, anxiety, and pain intensity taken at baseline and postintervention. RESULTS: This study was feasible to implement and deemed acceptable by participants. After 8 weeks, significant improvements were found on all outcome measures for both treatment groups, and large between-group effect sizes favoring CBT-M were found for BDD symptom severity (d=-0.96), depression (d=-1.06), pain severity (d=-1.12), and pain interference (d=-1.28). However, linear mixed models demonstrated no significant differences between the groups over 8 weeks. CONCLUSIONS: The results suggest that mindfulness meditation may add to beneficial web-based CBT treatment effects for BDD. An adequately powered randomized control trial of web-based CBT-M is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT05402475, http://clinicaltrials.gov/ct2/show/NCT05402475.

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BACKGROUND: Cocaine craving is a central symptom of cocaine use disorders (CUD). Virtual reality cue-exposure therapy for craving (VRCET) allows more immersive, realistic, and controllable exposure than traditional non-VR cue-exposure therapy (CET), whose efficacy is limited in treating substance use disorders. The purpose of this study is to evaluate the efficacy and acceptability of VRCET, as a stand-alone and add-on intervention (i.e., combined with cognitive therapy), compared to a picture-based CET (PCET), in reducing self-reported cocaine craving in inpatients hospitalized for CUD. METHODS: Fifty-four inpatients hospitalized for CUD will be randomized in one of two intensive 3-week treatment arms: 10 meetings/2-week treatment of VRCET plus 5 meetings/1-week treatment of memory-focused cognitive therapy (MFCT; experimental arm), or 15 meetings/3-week treatment of PCET (active control arm). The Craving Experience Questionnaire (CEQ - F & S) will be used to assess the primary outcome, i.e., the post-treatment decrease of self-reported cocaine craving frequency (within the past 2 weeks) and intensity scores (in VR exposure to cocaine cues). Secondary endpoints include urinary, physiological, and self-reported cocaine use-related measures. Assessments are scheduled at pretreatment, after 2 weeks of treatment (i.e., VRCET vs. PCET), post-treatment (3 weeks, i.e., VRCET + MFCT vs. PCET), and at 1-month follow-up. Acceptability will be evaluated via (i) the Spatial Presence for Immersive Environments - Cybersickness along VRCET and (ii) the Client Satisfaction Questionnaires after 2 weeks of treatment and post-treatment. DISCUSSION: This study will be the first to evaluate the acceptability and efficacy of VRCET for CUD, as a psychotherapeutic add-on, to reduce both cocaine craving frequency and intensity. Additionally, this study will provide evidence about the specific interest of VRCET, compared to a non-VR-based CET, as a cue reactivity and exposure paradigm for treating substance use disorders. TRIAL REGISTRATION: NCT05833529 [clinicaltrials.gov]. Prospectively registered on April 17, 2023.

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INTRODUCTION: Emerging evidence supports mindfulness as a potential psychotherapy for post-traumatic stress disorder (PTSD). Individuals with subthreshold PTSD experience significant impairment in their daily life and functioning due to PTSD symptoms, despite not meeting the full diagnostic criteria for PTSD in DSM-5. Mindfulness skills, including non-judgmental acceptance, attentional control and openness to experiences may help alleviate PTSD symptoms by targeting characteristics such as intensified memory processing, dysregulated hyperarousal, avoidance, and thought suppression. This trial aims to test the effects of mindfulness-based cognitive therapy (MBCT) when compared to an active control. METHOD AND ANALYSIS: This 1:1 randomised controlled trial will enroll 160 participants with PTSD symptoms in 2 arms (MBCT vs. Seeking Safety), with both interventions consisting of 8 weekly sessions lasting 2 h each week and led by certified instructors. Assessments will be conducted at baseline (T0), post-intervention (T1), and 3 months post-intervention (T2), with the primary outcome being PTSD symptoms measured by the PTSD checklist for DSM-5 (PCL-5) at T1. Secondary outcomes include depression, anxiety, attention, experimental avoidance, rumination, mindfulness, and coping skills. Both intention-to-treat and per-protocol analyses will be performed. Mediation analysis will investigate whether attention, experimental avoidance, and rumination mediate the effect of mindfulness on PTSD symptoms. DISCUSSION: The proposed study will assess the effectiveness of MBCT in improving PTSD symptoms. The findings are anticipated to have implications for various areas of healthcare and contribute to the enhancement of existing intervention guidelines for PTSD. TRIAL REGISTRATION NUMBER: ChiCTR2200061863.

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