BACKGROUND: Mindfulness-based treatments gained popularity for migraine treatment. In this manuscript we report the results of a single-arm open pilot study that evaluated the impact of a multimodal web-based intervention combining home-based medication withdrawal, patients\' education, and online mindfulness-based interventions. We aimed to address whether our program had the ability to show a change in the observed parameters and the study should therefore be intended as an early phase trial.
METHODS: Consecutive patients with chronic migraine associated with medication overuse headache were enrolled, followed-up for 12 months, in a program that included home-based medication withdrawal, education on the correct use of drugs and lifestyle issues, prescription of tailored pharmacological prophylaxis, and attendance to six online mindfulness-based sessions. We tested the effect of the program on improving headache frequency, medication intake, quality of life (QoL), headache impact, depression, self-efficacy, and pain catastrophizing.
RESULTS: A total of 37 patients completed the study (10 dropped out). We observed a large improvement in headache frequency, medication intake, headache impact, and QoL, a moderate improvement in pain catastrophizing and a mild improvement in depression symptoms; 70% to 76% of patients achieved 50% or more reduction in headache frequency from baseline to each follow-up (p < .01).
CONCLUSIONS: The results of our multimodal program showed significant improvements in headache frequency, medication intake, and patient-reported outcomes. Future studies are needed to better identify patients who might benefit most from Digital Health Interventions and to demonstrate at least an equivalence in outcome with in-person programs carried out in hospital settings.

UNASSIGNED: Transcutaneous Electrical Acupoint Stimulation (TEAS) therapy opens up the possibility for individuals with Cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. The aim of this study is designed to evaluate the efficacy of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC).
UNASSIGNED: This is a study protocol for a prospective, triple-blind, randomized controlled trial. We anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The true group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this investigation is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, quality of life scale, mood scales, and routine blood counts on the assessment days. Any adverse events will be promptly addressed and reported if they occur. We will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight.
UNASSIGNED: PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture and to explore a safe and effective integrative medicine scheme for CIBP.
UNASSIGNED: ClinicalTrials.gov NCT05730972, registered February 16, 2023.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) has become one of the most effective treatments for the resolution of actinic keratosis (AK) of Olsen grade 1 and 2. Generally, PDT it is carried out in a clinic setting, which involves the patient\'s and their caregivers commuting to the hospital as well as a significant use of resources to carry it out within the clinic setting.
OBJECTIVE: To determine the efficacy and safety of a home-based treatment of AK with DL-PDT with the BF-200 ALA gel compared to a clinic-based setting.
METHODS: The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. 9 patients received one clinic-based DL-PDT (group 1) and 11 patients received one session of home-based DL-PDT (group 2). The primary endpoints were the mean AK clearance per patient and the total AK lesion clearance rate 12 weeks after treatment. The secondary endpoints were the number of remaining AKs and new AKs appearing in the treatment field 12 weeks after one PDT session. The pain during and 24 h after PDT as well as the local skin reactions were also assessed.
RESULTS: The overall reduction of AK lesions per patient was similar in both groups with one PDT session. An overall AK clearance per patient of 10 ± 4.33 for group 1 versus 9.73 ± 2.9 for group 2 without statistically significant differences (p = 0.868). Regarding the clearance rate, although it was slightly higher in group 2 (71.58 ± 22.51 vs 82.1 ± 11.13), the analysis did not show statistically significant differences. The mild pain recorded during the treatment course and the mild local skin reactions were similar in both groups. Patient satisfaction was high for both groups without statistically significant differences.
CONCLUSIONS: Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment.

BACKGROUND: Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert therapeutic effects in patients with major depressive disorder (MDD). Due to its beneficial safety profile, its easy mode of application, and its cost-effectiveness, tDCS has recently been proposed for treatment at home. This would offer new chances for regionally widespread and long-term application. However, tDCS at home must meet the new methodological challenges of handling and adherence. At the same time, data from randomized controlled trials (RCT) investigating this mode of application are still lacking. In this pilot RCT, we therefore investigate the feasibility, safety, and effectiveness of a new antidepressant tDCS application set-up.
METHODS: The HomeDC trial will be conducted as a double-blind, placebo-controlled, parallel-group design trial. Thirty-two study participants with MDD will be randomly assigned to active or sham tDCS groups. Participants will self-administer prefrontal tDCS for 6 weeks. Active tDCS will be conducted with anode over F3, cathode over F4, for 5 sessions/week, with a duration of 30 min/day, and 2 mA stimulation intensity. Sham tDCS, conversely, follows an identical protocol in regard to electrode montage and timing, but with no electric stimulation between the ramp-in and ramp-out periods. Both conditions will be administered either as a monotherapy or an adjunctive treatment to a stable dose of antidepressant medication. Adjunctive magnetic resonance imaging (MRI) and electric field (E-field) modelling will be conducted at baseline. Primary outcome is feasibility based on successfully completed stimulations and drop-out rates. The intervention is considered feasible when 20 out of 30 sessions have been fully conducted by at least 75% of the participants. Effectiveness and safety will be assessed as secondary outcomes.
CONCLUSIONS: In the HomeDC trial, the technical requirements for a placebo-controlled tDCS study in a home-based treatment setting have been established. The trial addresses the crucial points of the home-based tDCS treatment approach: uniform electrode positioning, frequent monitoring of stimulation parameters, adherence, and ensuring an appropriate home treatment environment. This study will further identify constraints and drawbacks of this novel mode of treatment.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021.

The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505 . *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 . For more information, visit: http://www.prisma-statement.org/.

Although family-based treatment (FBT) is considered a first-line treatment for adolescent anorexia nervosa (AN), it is underutilized in community settings and is unavailable to many families for a multitude of practical reasons (e.g., costs of treatment, transportation constraints). Adapting FBT interventions for delivery in home-based and community-based settings may reduce pragmatic barriers to treatment uptake and engagement.
This pilot effectiveness-implementation trial will assess outcomes, implementation, and mechanisms of FBT adapted for the home setting (FBT-HB), delivered in the context of community-based behavioral health agencies. Adolescents with AN-spectrum disorders (n = 50) and their caregivers will be randomly assigned to either FBT-HB or home-based treatment as usual (TAU; integrated family therapy approach). Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy and adolescent eating-related and weight-related distress. Implementation constructs of feasibility, acceptability, and appropriateness will be measured among providers and participating families.
We expect that FBT-HB will be feasible, acceptable, and appropriate, and will outperform TAU in terms of improvements in adolescent weight and eating-related psychopathology. We further expect that caregiver self-efficacy and adolescent eating-related and weight-related distress, but not general distress, will show greater improvements in FBT-HB relative to TAU and will be associated with better adolescent weight and eating outcomes in FBT-HB.
The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of FBT for AN, including whether adapting it for the home setting improves its accessibility and effects on treatment outcome.

High treatment attrition and limited reach of mental health services for at-risk families remains an important problem in order to effectively address the global concern of child maltreatment and child disruptive behavior problems. This study evaluated the effectiveness of a home-based and time-limited adaptation of Parent-Child Interaction Therapy (PCIT). Twenty families with children (70% boys) aged between three and seven years were randomly assigned to an immediate treatment group (IT, n = 10) or a waitlist control group (WL, n = 10). After receiving treatment and compared to mothers in the WL group, mothers in the IT group reported fewer child behavior problems and more improved parenting skills. Although initial analyses revealed no significant differences, additional analyses showed a significant decrease in the primary outcome of the study, namely child abuse potential, between the baseline and follow-up assessment for the total treated sample. A low treatment attrition rate (15%) was found, indicating higher accessibility of treatment for families. Findings suggest that the brief home-based PCIT is a potentially effective intervention to prevent child maltreatment and disruptive behavior problems in at-risk families. Results also reinforce the importance of addressing the specific needs of these families to increase treatment effectiveness.

Introduction: Optimizing individual outcomes of cognitive-behavioral therapy (CBT) remains a priority. Methods: Youth were randomized to receive intensive CBT at a hospital clinic (n = 14) or within their home (n = 12). Youth completed 3 × 3 h sessions (Phase I) and up to four additional 3-h sessions as desired/needed (Phase II). An independent evaluator assessed youth after Phase I, Phase II (when applicable), and at 1- and 6-months post-treatment. A range of OCD-related (e.g., severity, impairment) and secondary (e.g., quality of life, comorbid symptoms) outcomes were assessed. Results: Families\' satisfaction with the treatment program was high. Of study completers (n = 22), five youth (23%) utilized no Phase II sessions and 9 (41%) utilized all four (Median Phase II sessions: 2.5). Large improvements in OCD-related outcomes and small-to-moderate benefits across secondary domains were observed. Statistically-significant differences in primary outcomes were not observed between settings; however, minor benefits for home-based treatment were observed (e.g., maintenance of gains, youth comfort with treatment). Discussion: Intensive CBT is an efficacious treatment for pediatric OCD. Families opted for differing doses based on their needs. Home-based treatment, while not substantially superior to hospital care, may offer some value, particularly when desired/relevant. Clinical Trial Registration: www.ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT03672565, identifier: NCT03672565.

OBJECTIVE: The effect of contrast-balanced dichoptic video game training on distance visual acuity (DVA) and stereo acuity has been investigated in severe-to-moderate amblyopia, but its effect on mild amblyopia and fixation stability has not been assessed. This pilot study aimed to evaluate the effect of home-based dichoptic video game on amblyopic eye DVA, stereo acuity and fixation stability in adults with mild amblyopia.
METHODS: A randomized single-masked design was adopted. The active 6-week home-based treatment was an anaglyphic, contrast-balanced dichoptic video game, and the placebo was an identical non-dichoptic game. Participants (n = 23) had mild amblyopia (amblyopic DVA ≤ 0.28 log Minimum Angle of Resolution (logMAR)). The primary outcome was change in amblyopic DVA at 6 weeks postrandomization. Near visual acuity, stereo acuity and fixation stability (bivariate contour eclipse area) were also measured. Follow-up occurred at 12 and 24 weeks postrandomization.
RESULTS: Mean amblyopic eye DVA was 0.21 ± 0.06 and 0.18 ± 0.06 logMAR for the active (n = 12) and placebo (n = 11) group, respectively. Amblyopic DVA improved significantly more in the active group (0.09 ± 0.05) than in the placebo group (0.03 ± 0.04 logMAR; p < 0.05). The difference between groups remained at 12 weeks postrandomization (p = 0.04) but not at 24 weeks (p = 0.43). Titmus stereo acuities improved significantly more in the active group (0.40 log arcsec) than in the placebo group (0.09 log arcsec) after 6 weeks of gameplay. The between-group difference was still present at 24 weeks postrandomization (p = 0.05). There were no differences between groups on any other secondary outcomes.
CONCLUSIONS: Home-based dichoptic video gameplay may be an effective method to improve amblyopic DVA and stereo acuity in mild amblyopia.

This study aimed to compare outcomes in patients with head and neck lymphedema receiving either a home-based lymphedema treatment program or a hybrid approach including both home-based treatment and regular clinical visits.
Outcomes were assessed in patients receiving head and neck lymphedema rehabilitation. Baseline measures of neck, submental, and facial edema were obtained and repeated following treatment. A home program was recommended for all patients, and those receiving hybrid care received the same recommendations as well as a visit with the lymphedema therapist for additional treatment. Their outcomes were compared using standard statistical analysis.
Fifty consecutive individuals were included, 25 in each group. Adherence to at least 50% of recommended treatment was reported in 68% of those receiving home-based treatment and 84% of those receiving hybrid care. Significant improvement was demonstrated for 66% of patients. There was no statistically significant difference between treatment groups with regard to clinically significant improvement (P = .15). Patients receiving hybrid therapy demonstrated treatment advantages regarding facial edema (P = .037). Adherence to treatment was associated with clinical improvement (P = .047).
Comparable benefits were observed regardless of whether patients had a home-based or hybrid lymphedema treatment approach. These data suggest a home-based treatment approach may be appropriate for patients unable to participate in clinical sessions. However, for patients with significant facial edema, a hybrid approach may be preferable. Adherence was associated with better outcomes. Given these findings, future investigations should consider strategies to improve adherence to optimize the outcomes lymphedema treatment.
3b Laryngoscope, 2020.