Effectiveness of a mindfulness-based mobile application for the treatment of depression in ambulatory care: study protocol for a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Jan Sarlon
Keyword(s):  
Ambulatory Care ◽  
Symptom Severity ◽  
Mobile Application ◽  
Rating Scale ◽  
Controlled Trial ◽  
Mobile App ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Treatment As Usual ◽  
Randomized Controlled

BACKGROUND Patients with Major Depressive Disorder (MDD) often experience relapses despite regular treatment with pharmacotherapy and psychotherapy. Further, long waiting lists and more demand than treatment capacity characterize ambulatory settings. Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. OBJECTIVE The aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU. METHODS A total of 140 individuals with MDD will be randomly allocated to the intervention or control condition. The intervention consists of the daily use of the mindfulness mobile application “Headspace” for thirty days (up to 10 minutes a day). The control condition will be treatment as usual. At baseline and four weeks later, the following key outcome dimensions will be assessed: self-rated (Beck Depression Inventory) and experts’ rated symptoms of MDD (Hamilton Depression Rating Scale; HDRS); secondary outcome variables will be: blood pressure, heart rate, and respiratory rate; changes in tobacco and alcohol consumption and medication as a proxy of perceived stress. RESULTS No available yet. CONCLUSIONS We hypothesize that compared to the control conditions, individuals with MDD of the mobile app-condition will have both lower self- and experts’ rated symptoms of MDD and more favorable stress-related levels. While the risk for medical events is low, the immediate benefit for participants could be a decrease of symptom severity and prevention of depressive relapse. CLINICALTRIAL Clinical Trials.gov NCT05060393. Trial Registration date 28 September 2021, retrospectively registered

scholarly journals Incongruent Expression of Brain-Derived Neurotrophic Factor and Cortisol in Schizophrenia: Results from a Randomized Controlled Trial of Laughter Intervention

2020 ◽  
Vol 17 (12) ◽  
pp. 1191-1199
Author(s):  
Shu-Li Cheng ◽  
Fu-Chi Yang ◽  
Hsuan-Te Chu ◽  
Chia-Kuang Tsai ◽  
Shih-Chieh Ku ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Serum Levels ◽  
Controlled Study ◽  
Control Group ◽  
Delayed Effect ◽  
Treatment As Usual ◽  
Early Effect ◽  
Clinical Criteria ◽  
Randomized Controlled ◽  
Group Control Group

Objective Schizophrenia has been associated with dysfunction of the hypothalamic-pituitary-adrenal axis. Furthermore, alterations in neurotrophic factors might contribute to the pathogenesis of schizophrenia. We aimed to evaluate the effects of a simulated laughter intervention on the levels of cortisol and BDNF and to determine whether the effects associated with simulated laughter could be sustained after discontinuation of the intervention. Methods In this randomized controlled study, patients with schizophrenia according to DSM-IV clinical criteria were randomly assigned to receive either 8-week-long simulated laughter intervention (n=32) or treatment-as-usual group (control group, n=27). The serum levels of BDNF and cortisol were measured at baseline, week 8, and four weeks after discontinuation (week 12) of the intervention program.Results After an 8-week simulated laughter intervention, the laughter group had significantly higher levels of BDNF; however, four weeks after discontinuation of the intervention, the levels of BDNF significantly dropped. Interestingly, the levels of cortisol did not change significantly at week 8, but they were significantly elevated at week 12. The levels of BDNF and cortisol in the control group did not change significantly between week 0 and week 8.Conclusion These findings suggest that the simulated laughter intervention has an early effect on neurogenesis with a significant delayed effect on stress regulation in subjects with schizophrenia.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Electroacupuncture Treatment

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This trial protocol provides an example of clinical application for the management of postoperative pain using electroacupuncture treatment. If the electroacupuncture treatment protocol confirms that this treatment method is effective and safe, it can be implemented as a standard of care for relieving postoperative pain in Chinese and Western medicine.

An early interactive human coaching via a mobile application to improve quality of life in patients who underwent gastrectomy for gastric cancer: Design and protocol of a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Hak Jin Kim ◽  
Hong Man Yoon ◽  
Keun Won Ryu ◽  
Young-Woo Kim ◽  
So Young Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Human Health ◽  
Mobile Application ◽  
Controlled Trial ◽  
Health Coaching ◽  
Mobile App ◽  
Face To Face ◽  
Randomized Controlled

BACKGROUND After gastrectomy, patients may experience the postgastrectomy syndrome and face difficulties adapting to everyday diet. Recently, human health coaching via a mobile application (app) has been used for obese patients or patients with chronic diseases, with significant improvements in clinical outcomes. OBJECTIVE The aim of this study is to evaluate and compare the effects of human health coaching via a mobile app and conventional face-to-face counseling in patients who underwent gastrectomy for gastric cancers. METHODS This study is a single-institution, prospective randomized controlled trial comparing the mobile health and face-to-face counselling groups. After randomization, participants assigned to the mobile health coaching group will receive health coaching via a mobile app for 3 months after discharge, and the assigned coaches will provide personalized advice based on the self-recorded health data. Participants in the face-to-face group will have 1- and 3-months postoperative dietary consultations with a clinical dietitian. The primary endpoint is the food restriction score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22, and secondary endpoints included all other quality of life scale scores and nutritional parameters. The calculated sample size is 180, and the outcomes will be measured until 1-year post-surgery. RESULTS Recruitment started in May, 2020 and currently 51 patients have enrolled in the study. Anticipated date for the completion of enrolment is December 31, 2021 and entire data collection is expected to be completed by December 2022. CONCLUSIONS This study will show the efficacy of human health coaching via a mobile app on dietary adaptation in patients who underwent gastrectomy. A relational approach based on personal data and timely intervention using a mobile platform could reduce patients’ trial and error and improve QoL. CLINICALTRIAL ClinicalTrials.gov, NCT04394585; http://clinicaltrials.gov/ct2/show/NCT040394585

scholarly journals Comparison of Pure Tone, Dichotic Digit Test and Speech in Noise in Persian Language Using a Mobile-Based Approach (Shenava® application) with the Audiometer Device: Protocol of the Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 46
Author(s):  
Firoozeh Khordastan ◽  
Jila Afsharmanesh ◽  
Maryam Amizadeh ◽  
Afshin Sarafi Nejad
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Mobile Application ◽  
Pure Tone ◽  
Controlled Trial ◽  
Mobile App ◽  
Control Group ◽  
Hearing Tests ◽  
Speech In Noise ◽  
Randomized Controlled

Introduction: The global prevalence of hearing loss is around 5 percent in low to middle-income countries. The main purpose of this study is validating a mobile-based Pure Tone Audiometry (PTA), Dichotic Digit Test (DDT) and Speech in Noise (SIN) hearing tests for hearing loss screening purposes in Persian people comparing with routine audiometry exam results.Material and Methods: This is a single blind randomized controlled trial for comparing a mobile application for hearing screening exams. We designed and standardized PTA, DDT and SIN tests for Persian people and settled them into a specific developed mobile application called “Shenava®”. In the audiology clinic, we will recruit at least 100 healthy adult participants, 50 for the case and 50 for the control group. The first group will pass “Shenava®” and standard test respectively and the other group will pass the tests vice versa to prevent order bias.Results: The results of the tests performed by “Shenava®” and audiometry exam will be analyzed to ensure the accuracy and validity of the” Shenava®” in comparison with standard audiometric exam results.Conclution: Hearing tests are costly even for time and money and need a lot of efforts for audiologists and the patients. By designing a mobile app for hearing tests, we hope to be able to make diagnostic screening easier for hearing loss, and relying on the diagnostic value of this tool, it may encourage the patients to have a better follow up and effective treatment plan.

scholarly journals Augmenting Outpatient Alcohol Treatment as Usual With Online Alcohol Avoidance Training: Protocol for a Double-Blind Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Marleen KJ Bratti-van der Werf ◽  
Melissa C Laurens ◽  
Marloes G Postel ◽  
Marcel E Pieterse ◽  
Somaya Ben Allouch ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outpatient Treatment ◽  
Avoidance Training ◽  
Controlled Trial ◽  
Treatment Setting ◽  
Secondary Outcome ◽  
Double Blind ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Number Of Patients

BACKGROUND Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically. OBJECTIVE The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting. METHODS The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients’ adherence, acceptability, and credibility will be examined. RESULTS The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020. CONCLUSIONS The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment. CLINICALTRIAL Netherlands Trial Register NTR5087; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087 (Archived at WebCite http://www.webcitation.org/6wuS4i1tH)

scholarly journals Cognitive-behavioral family therapy as psychoeducation for adolescents with high-functioning autism spectrum disorders: Aware and Care for my Autistic Traits (ACAT) program study protocol for a pragmatic multisite randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fumiyo Oshima ◽  
Mandy William ◽  
Noriko Takahashi ◽  
Aki Tsuchiyagaito ◽  
Hitoshi Kuwabara ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Autistic Traits ◽  
Autism Spectrum ◽  
Cognitive Behavioral ◽  
Secondary Outcome ◽  
High Functioning ◽  
Randomized Controlled ◽  
Japanese Adolescents

Abstract Background One aim of an autism spectrum disorder (ASD) diagnosis is to obtain special support for the disorder, though this does not guarantee practical support. We developed a psychoeducational program using cognitive-behavioral therapy (CBT) and Aware and Care for my Autistic Traits (ACAT) for Japanese adolescents with high-functioning ASD and their parents. Methods This multisite study is a randomized controlled trial. In total, 24 participants will be assigned to the ACAT group and 24 to the treatment-as-usual (TAU) group. The ACAT group will receive a weekly 100-min session for 6 weeks, regular medical care, and one follow-up session. In this ongoing clinical trial, we will compare the scores of the measures recorded in the pre- and post-intervention stages between the ACAT and TAU groups. A total of 41 patients out of a target of 48 have participated in the trial to date. The primary outcome measure is the Autism Knowledge Questionnaire. Secondary outcome measures include Barriers to Access to Care Evaluation 3rd Edition, the Strengths and Difficulties Questionnaire, the Vineland Adaptive Behavior Scales second edition, the Parenting Resilience Elements Questionnaire, the General Health Questionnaire 12, and the Depression Self-Rating Scale for Children assessments, as well as an electroencephalographic recording. Discussion It is expected that participants in the ACAT group will significantly increase their self-understanding and awareness of ASD symptoms compared to those in the TAU group. Additionally, the ACAT group is expected to exhibit improved social adaptation and mental health if children and parents are able to better understand the ASD characteristics through sessions. This intervention will contribute to the establishment of an effective evidence-based treatment strategy for adolescents with ASD. Trial registration UMIN Register 000029851. Registered on January 06, 2018

scholarly journals Efficacy and safety of Yinxing Mihuan oral solution in the treatment of patients with post-PCI chest pain: A multicenter, prospective, randomized, double-blind, placebo-controlled study

2021 ◽  
Author(s):  
Danping Xu ◽  
Bingxin Wu ◽  
Zikai Yu ◽  
Jinhai Lin ◽  
Haiyan Xu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chest Pain ◽  
Medical Treatment ◽  
Rating Scale ◽  
Oral Solution ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background：Coronary artery disease (CHD) now accounts for approximately one third of all deaths globally and up to one-quarter of patients may have either continues or recurrent post-PCI chest pain. Yinxing Mihuan oral solution (YMOS) has been proven to bring clinical benefits for patients with CHD and Ginkgo biloba extract can relieve depression in mice. No high-quality randomized controlled trials on YMOS have been published. The aim of this study is to evaluate the efficacy and safety of Yinxing Mihuan oral solution (YMOS) in the treatment of patients with post-percutaneous coronary intervention (PCI) chest pain. This study also aimed to relieve the symptoms of chest pain as a primary outcome, improve the anxiety as a secondary outcome, assess therapeutic effects of YMOS on chest pain, and explore its effects on chest pain caused by psychological disorders after PCI.Methods: 320 patients with symptoms related to heart and a confirmed history of PCI for coronary heart disease (CHD) without the need to undergo selective coronary revascularization plan were recruited in this randomized controlled trial. The included participants were randomly assigned (at a ratio of 1:1) to experimental group and control group; patients in the experimental group received YMOS and standardized medical treatment, while those in control received placebo (10 ml) for three times/day for 12 weeks and standardized medical treatment regimen. The endpoints of the study included Seattle angina questionnaire (SAQ) score, Hamilton anxiety rating scale (HAMA), Hamilton rating scale for depression (HRSD), Canadian Cardiovascular Society (CCS) angina score, New York Heart Association (NYHA) classification, visual analogue scale (VAS), 12-Item short form survey (SF-12), frequency of angina-related symptoms per week, nitroglycerin discontinuation, and reduction rate of HAMA score.Discussion: This clinical trial can provide reliable evidence regarding the efficacy and safety of YMOS for patients with post-PCI chest pain.Trial registration: This research has been registered at the Chinese Clinical Trial Registry (Registration No. ChiCTR2000028760) on January 1, 2020. http://www.chictr.org.cn/showproj.aspx?proj=47528

scholarly journals Comparison of a practice-based versus theory-based training program for conducting vacuum-assisted deliveries: a randomized-controlled trial

2021 ◽  
Author(s):  
Julian Marschalek ◽  
Lorenz Kuessel ◽  
Maria Stammler-Safar ◽  
Herbert Kiss ◽  
Johannes Ott ◽  
...  
Keyword(s):  
Training Program ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Groups ◽  
Controlled Study ◽  
Initial Training ◽  
Randomized Controlled ◽  
Need To Evaluate ◽  
Vacuum Delivery ◽  
Baseline Test

Abstract Purpose Vacuum-assisted deliveries (VAD) are complex procedures that require training and experience to be performed proficiently. We aimed to evaluate if a more resource intensive practice-based training program for conducting VAD is more efficient compared to a purely theory-based training program, with respect to immediate training effects and persistence of skills 4–8 weeks after the initial training. Methods In this randomized-controlled study conducted in maternity staff, participants performed a simulated low-cavity non-rotational vacuum delivery before (baseline test) and immediately after the training (first post-training test) as well as 4–8 weeks thereafter (second post-training test). The study’s primary endpoint was to compare training effectiveness between the two study groups using a validated objective structured assessment of technical skills (OSATS) rating scale. Results Sixty-two participants were randomized to either the theory-based group (n = 31) or the practice-based group (n = 31). Total global and specific OSATS scores, as well as distance of cup application to the flexion point improved significantly from baseline test to the first post-training test in both groups (pall < 0.007). Skill deterioration after 4–8 weeks was only found in the theory-based group, whereas skills remained stable in the practice-based group. Conclusion A practice-based training program for conducting VAD results in comparable immediate improvement of skills compared to a theory-based training program, but the retention of skills 4–8 weeks after training is superior in a practice-based program. Future studies need to evaluate, whether VAD simulation training improves maternal and neonatal outcome after VAD.

scholarly journals Two Novel Cognitive Behavioral Therapy�Based Mobile Apps for Agoraphobia: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Marina Christoforou ◽  
José Andrés Sáez Fonseca ◽  
Elias Tsakanikos
Keyword(s):  
Randomized Controlled Trial ◽  
Symptom Severity ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Large Body ◽  
Mobile App ◽  
Cognitive Behavioral ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Despite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions. OBJECTIVE The objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety. METHODS A Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale. RESULTS Both groups had statistically significant improvements in symptom severity over time (difference –5.97, 95% CI –8.49 to –3.44, P<.001 for Agoraphobia Free and –6.35, 95% CI –8.82 to –3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI –1.96 to 3.20, P=.64). CONCLUSIONS This is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw)

scholarly journals 150 HAM-D6 Outcomes in a Randomized, Controlled Trial Evaluating the Utility of Combinatorial Pharmacogenomics in Depression

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 295-296
Author(s):  
Boadie W. Dunlop ◽  
Sagar V. Parikh ◽  
Maitrey Patel ◽  
Anthony J. Rothschild ◽  
Michael E. Thase ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Patient Outcomes ◽  
Active Treatment ◽  
Rating Scales ◽  
Rating Scale ◽  
Controlled Trial ◽  
Symptom Improvement ◽  
Depression Symptom ◽  
Treatment As Usual ◽  
Randomized Controlled

Abstract:Background:The Genomics Used to Improve DEpresssion Decisions (GUIDED) trial assessed outcomes associated with combinatorial pharmacogenomic (PGx) testing in patients with major depressive disorder (MDD). Analyses used the 17-item Hamilton Depression (HAM-D17) rating scale; however, studies demonstrate that the abbreviated, core depression symptom-focused, HAM-D6 rating scale may have greater sensitivity toward detecting differences between treatment and placebo. However, the sensitivity of HAM-D6 has not been tested for two active treatment arms. Here, we evaluated the sensitivity of the HAM-D6 scale, relative to the HAM-D17 scale, when assessing outcomes for actively treated patients in the GUIDED trial.Methods:Outpatients (N=1,298) diagnosed with MDD and an inadequate treatment response to >1 psychotropic medication were randomized into treatment as usual (TAU) or combinatorial PGx-guided (guided-care) arms. Combinatorial PGx testing was performed on all patients, though test reports were only available to the guided-care arm. All patients and raters were blinded to study arm until after week 8. Medications on the combinatorial PGx test report were categorized based on the level of predicted gene-drug interactions: ‘use as directed’, ‘moderate gene-drug interactions’, or ‘significant gene-drug interactions.’ Patient outcomes were assessed by arm at week 8 using HAM-D6 and HAM-D17 rating scales, including symptom improvement (percent change in scale), response (≥50% decrease in scale), and remission (HAM-D6 ≤4 and HAM-D17 ≤7).Results:At week 8, the guided-care arm demonstrated statistically significant symptom improvement over TAU using HAM-D6 scale (Δ=4.4%, p=0.023), but not using the HAM-D17 scale (Δ=3.2%, p=0.069). The response rate increased significantly for guided-care compared with TAU using both HAM-D6 (Δ=7.0%, p=0.004) and HAM-D17 (Δ=6.3%, p=0.007). Remission rates were also significantly greater for guided-care versus TAU using both scales (HAM-D6 Δ=4.6%, p=0.031; HAM-D17 Δ=5.5%, p=0.005). Patients taking medication(s) predicted to have gene-drug interactions at baseline showed further increased benefit over TAU at week 8 using HAM-D6 for symptom improvement (Δ=7.3%, p=0.004) response (Δ=10.0%, p=0.001) and remission (Δ=7.9%, p=0.005). Comparatively, the magnitude of the differences in outcomes between arms at week 8 was lower using HAM-D17 (symptom improvement Δ=5.0%, p=0.029; response Δ=8.0%, p=0.008; remission Δ=7.5%, p=0.003).Conclusions:Combinatorial PGx-guided care achieved significantly better patient outcomes compared with TAU when assessed using the HAM-D6 scale. These findings suggest that the HAM-D6 scale is better suited than is the HAM-D17 for evaluating change in randomized, controlled trials comparing active treatment arms.Funding Acknowledgements:Assurex Health, Inc.

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