[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07195292":3,"trial-entities:NCT07195292":293,"trial-summary:NCT07195292":298},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":52,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":89,"locations":92,"central_contacts":160,"overall_officials":165,"references":166,"see_also_links":271},"NCT07195292","00084427","Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching","Reduction of Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (ReDu)","NOT_YET_RECRUITING","2027-08","2026-07","2026-07-20","2026-08","Toivoa Inc","INDUSTRY",false,"The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-002, which combines digital cognitive behavioral therapy (CBT) with personal coaching, can effectively reduce depression in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering depression symptoms over an 8-week period than a \"sham\" digital program that is developed to look similar but does not contain active therapeutic content. The investigators hypothesize that participants who use the Toivoa-002 program will show significantly greater reductions in depression compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up. Adults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen depression. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective depression relief tailored to the lived experiences of people with disabilities.","This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-002, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified coaching, in reducing depression symptoms compared to a sham digital program.\n\nRecruitment will focus on adults with hearing or mobility disabilities, chosen to represent the broader U.S. disability community due to shared barriers to social participation, high prevalence of depression, and common co-morbidities. Depression in these populations often stems from environmental and societal barriers, such as limited accessibility, transportation challenges, and workplace inflexibility, rather than the medical condition alone.\n\nParticipants will be randomized to either intervention or control group.\n\nThe primary endpoint is change in evaluator-administered Hamilton Depression Rating Scale (HAM-D) from baseline to Week 8. Secondary endpoints include durability of effect at Week 12, Clinical Global Impression of Improvement (CGI-I) at Weeks 8 and 12, and proportion achieving a clinically meaningful response. Exploratory endpoints assess changes in anxiety (HAM-A) and self-reported depression (PHQ-9) at Week 8.\n\nAssessments will be conducted at baseline, mid-treatment, end of treatment (Week 8), and follow-up (Week 12). Self-report measures (PHQ-9, GAD-7) will be collected at baseline and biweekly during the intervention.\n\nRecruitment will occur at up to 10 geographically dispersed U.S. sites, including Veterans Affairs healthcare facilities and academic institutions, using outreach through specialty clinics, events, and online platforms. The trial aims to enroll a diverse participant population without restrictions on gender, race, ethnicity, religion, or sexual orientation.\n\nThe study is designed to generate evidence on the effectiveness and durability of a dual-intervention approach, digital CBT plus coaching, for depression reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.",[19,20,21],"Hearing Disability","Depression","Mobility Disability",[20,23,24,25,26,27],"People with Hearing or Mobility Disability","Accessible Health for People with Disabilities and Veterans","Cognitive Behavioral Therapy","Cognitive Behavioral Therapy with Coaches","Coaches","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},200,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT.","General health and wellness information with interactive quizzes. This content is not related to depression treatment or CBT techniques.",[41],"General Health Education + Interactive Quizzes",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.","A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches",[46],"Toivoa-002 Digital CBT + NBHWC Coaching",[48],{"measure":49,"description":50,"timeFrame":51},"Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8","The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 (\"not present\") to 4 (\"severe\") and 0 (\"absent\") to 2 (\"severe\"). Total scores range 0 to 54. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population including Baseline and Weeks 4 and 8 as repeated post-baseline measurements. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, study site, and Baseline HAM-D as a covariate. Within-participant correlation across repeated measurements will be modeled using a covariance structure. The primary treatment comparison will be the difference between treatment groups in least squares mean change from Baseline to Week 8. Statistical significance will be assessed based on the Week 8 treatment contrast from the MMRM. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.","From Baseline to end of treatment (8 weeks)",[53,57,60,63],{"measure":54,"description":55,"timeFrame":56},"Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 12","The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 (\"not present\") to 4 (\"severe\") and 0 (\"absent\") to 2 (\"severe\"). Total scores range 0 to 54. Change from Baseline Assessment to Week 12 in HAM-D total score will be analyzed using an MMRM analogous to that used for the primary endpoint. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, and study site, with Baseline Assessments HAM-D total score included as a covariate. Post-baseline assessments at Weeks 4, 8, and 12 will be included in the model. The treatment comparison of interest will be the between-group difference in least squares mean change from Baseline Assessments at Week 12. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.","From Baseline to 4 weeks after treatment (12 weeks)",{"measure":58,"description":59,"timeFrame":51},"Clinical Global Impression for Improvement (CGI-I) at Week 8","The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 (\"very much improved\") to 7 (\"very much worse\"). CGI-I at Week 8 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4 and 8 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.",{"measure":61,"description":62,"timeFrame":56},"Clinical Global Impression for Improvement (CGI-I) at Week 12","The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 (\"very much improved\") to 7 (\"very much worse\"). CGI-I at Week 12 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4, 8 and 12 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.",{"measure":64,"description":65,"timeFrame":51},"Proportion of participants achieving clinically meaningful response on Hamilton Depression Rating Scale (HAM-D) at Week 8","The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 (\"not present\") to 4 (\"severe\") and 0 (\"absent\") to 2 (\"severe\"). Total scores range 0 to 54. HAM-D response at Week 8, defined as a reduction of at least 4 points from Baseline Assessments in HAM-D total score, will be analyzed using Week 8 data only. Participants without a Week 8 assessment will be classified as non-responders. Response rates will be summarized by treatment group and compared using Pearson's chi-square test. The between-group difference in response rate and its 95% confidence interval will also be provided.","ALL","22 Years",null,{"inclusion":70,"exclusion":82,"raw_text":88},[71,72,73,74,75,76,77,78,79,80,81],"Provision of signed and dated informed consent form","Presence of self-reported hearing or mobility disability","Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study","Male or female, age 22 years or older","A score of 17 or higher on the HAM-D","Clinical diagnosis of depression based on DSM-5 diagnostic criteria","Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches","Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)","Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)","Able to read and speak English fluently","Resident of the United States and living in the United States for the duration of the trial",[83,84,85,86,87],"Medical diagnosis of psychotic disorder or bipolar disorder","Participation in another treatment trial at the time of study","Substance use disorder in the past 12 months (excluding tobacco)","Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations).","Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Presence of self-reported hearing or mobility disability\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Male or female, age 22 years or older\n* A score of 17 or higher on the HAM-D\n* Clinical diagnosis of depression based on DSM-5 diagnostic criteria\n* Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches\n* Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)\n* Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)\n* Able to read and speak English fluently\n* Resident of the United States and living in the United States for the duration of the trial\n\nExclusion Criteria:\n\n* Medical diagnosis of psychotic disorder or bipolar disorder\n* Participation in another treatment trial at the time of study\n* Substance use disorder in the past 12 months (excluding tobacco)\n* Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations).\n* Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period",[90,91],"ADULT","OLDER_ADULT",[93,116,131,146],{"facility":94,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":113},"Delaware State University","Dover","Delaware","19904","United States",[100,105,109,111],{"name":101,"role":102,"phone":103,"email":104},"Rosemarie White, DNP, CRNP-PMH, PMHNP-BC","CONTACT","302-760-1977","rawhite@desu.edu",{"name":106,"role":102,"phoneExt":107,"email":108},"Gwendolyn Scott-Jones, PsyD","302-736-2364","gscottjones@desu.edu",{"name":106,"role":110},"PRINCIPAL_INVESTIGATOR",{"name":112,"role":110},"Rosemarie White, DNP",{"lat":114,"lon":115},39.15817,-75.52437,{"facility":117,"city":118,"state":119,"zip":120,"country":98,"contacts":121,"geoPoint":128},"New Jersey Department of Veterans Health","East Orange","New Jersey","07018",[122,127],{"name":123,"role":102,"phone":124,"phoneExt":125,"email":126},"Monica Clement, PhD","973-676-1000","201645","monica.clement@va.gov",{"name":123,"role":110},{"lat":129,"lon":130},40.76732,-74.20487,{"facility":132,"city":133,"state":134,"zip":135,"country":98,"contacts":136,"geoPoint":143},"Louis Stokes Cleveland VAMC","Cleveland","Ohio","44016",[137,141],{"name":138,"role":102,"phone":139,"email":140},"Mary Ann Richmond, MD","216-791-3800","maryann.richmond@va.gov",{"name":142,"role":110},"MaryAnn Richmond, MD",{"lat":144,"lon":145},41.4995,-81.69541,{"facility":147,"city":148,"state":149,"zip":150,"country":98,"contacts":151,"geoPoint":157},"South Texas Veterans Health Care System","San Antonio","Texas","78229",[152,156],{"name":153,"role":102,"phone":154,"email":155},"Alicia A Swan, PhD","210-517-5541","alicia.swan@va.gov",{"name":153,"role":110},{"lat":158,"lon":159},29.42412,-98.49363,[161],{"name":162,"role":102,"phone":163,"email":164},"Laura Randa","612-237-5896","lranda@toivoa.us",[],[167,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,238,241,244,247,250,253,256,259,262,265,268],{"pmid":168,"type":169,"citation":170},"25273302","BACKGROUND","Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002\u002Fwps.20151.",{"pmid":172,"type":169,"citation":173},"22163317","Chen LH, Lee WC. Two-way minimization: a novel treatment allocation method for small trials. PLoS One. 2011;6(12):e28604. doi: 10.1371\u002Fjournal.pone.0028604. Epub 2011 Dec 7.",{"pmid":175,"type":169,"citation":176},"15809408","DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409-16. doi: 10.1001\u002Farchpsyc.62.4.409.",{"pmid":178,"type":169,"citation":179},"16881773","Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037\u002F0022-006X.74.4.658.",{"pmid":181,"type":169,"citation":182},"20183399","Gallop R, Tasca GA. Multilevel modeling of longitudinal data for psychotherapy researchers: II. The complexities. Psychother Res. 2009 Jul;19(4-5):438-52. doi: 10.1080\u002F10503300902849475.",{"pmid":184,"type":169,"citation":185},"8357299","Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry. 1993 Sep;50(9):739-50. doi: 10.1001\u002Farchpsyc.1993.01820210073009.",{"pmid":187,"type":169,"citation":188},"24274626","Gottfredson NC, Bauer DJ, Baldwin SA, Okiishi JC. Using a shared parameter mixture model to estimate change during treatment when termination is related to recovery speed. J Consult Clin Psychol. 2014 Oct;82(5):813-27. doi: 10.1037\u002Fa0034831. Epub 2013 Nov 25.",{"pmid":190,"type":169,"citation":191},"19739238","Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002\u002Fsim.3710.",{"pmid":193,"type":169,"citation":194},"26453453","Hill KG, Woodward D, Woelfel T, Hawkins JD, Green S. Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies. Prev Sci. 2016 Oct;17(7):806-18. doi: 10.1007\u002Fs11121-015-0610-7.",{"pmid":196,"type":169,"citation":197},"31441952","Katz I, Barry CN, Cooper SA, Kasprow WJ, Hoff RA. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) in a large sample of Veterans receiving mental health services in the Veterans Health Administration. Suicide Life Threat Behav. 2020 Feb;50(1):111-121. doi: 10.1111\u002Fsltb.12584. Epub 2019 Aug 23.",{"pmid":199,"type":169,"citation":200},"11556941","Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046\u002Fj.1525-1497.2001.016009606.x.",{"pmid":202,"type":169,"citation":203},"2963053","Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016\u002F0165-0327(88)90072-9.",{"pmid":205,"type":169,"citation":206},"22193671","Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176\u002Fappi.ajp.2011.10111704.",{"pmid":208,"type":169,"citation":209},"9734550","Reimherr FW, Amsterdam JD, Quitkin FM, Rosenbaum JF, Fava M, Zajecka J, Beasley CM Jr, Michelson D, Roback P, Sundell K. Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Am J Psychiatry. 1998 Sep;155(9):1247-53. doi: 10.1176\u002Fajp.155.9.1247.",{"pmid":211,"type":169,"citation":212},"34295161","Rush AJ, South C, Jain S, Agha R, Zhang M, Shrestha S, Khan Z, Hassan M, Trivedi MH. Clinically Significant Changes in the 17- and 6-Item Hamilton Rating Scales for Depression: A STAR*D Report. Neuropsychiatr Dis Treat. 2021 Jul 14;17:2333-2345. doi: 10.2147\u002FNDT.S305331. eCollection 2021.",{"pmid":214,"type":169,"citation":215},"18366819","Scott KM, Von Korff M, Alonso J, Angermeyer MC, Bromet E, Fayyad J, de Girolamo G, Demyttenaere K, Gasquet I, Gureje O, Haro JM, He Y, Kessler RC, Levinson D, Medina Mora ME, Oakley Browne M, Ormel J, Posada-Villa J, Watanabe M, Williams D. Mental-physical co-morbidity and its relationship with disability: results from the World Mental Health Surveys. Psychol Med. 2009 Jan;39(1):33-43. doi: 10.1017\u002FS0033291708003188. Epub 2008 Mar 26.",{"pmid":217,"type":169,"citation":218},"31995132","Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001\u002Fjamapsychiatry.2019.4693.",{"pmid":220,"type":169,"citation":221},"16717171","Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001\u002Farchinte.166.10.1092.",{"pmid":223,"type":169,"citation":224},"9544529","Ten Have TR, Kunselman AR, Pulkstenis EP, Landis JR. Mixed effects logistic regression models for longitudinal binary response data with informative drop-out. Biometrics. 1998 Mar;54(1):367-83.",{"pmid":226,"type":169,"citation":227},"8500309","Therneau TM. How many stratification factors are \"too many\" to use in a randomization plan? Control Clin Trials. 1993 Apr;14(2):98-108. doi: 10.1016\u002F0197-2456(93)90013-4.",{"pmid":229,"type":169,"citation":230},"3395203","Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001\u002Farchpsyc.1988.01800320058007.",{"pmid":232,"type":169,"citation":233},"11137194","Ahn C, Overall JE, Tonidandel S. Sample size and power calculations in repeated measurement analysis. Comput Methods Programs Biomed. 2001 Feb;64(2):121-124. doi: 10.1016\u002Fs0169-2607(00)00095-x.",{"pmid":235,"type":236,"citation":237},"29451967","RESULT","Carpenter JK, Andrews LA, Witcraft SM, Powers MB, Smits JAJ, Hofmann SG. Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials. Depress Anxiety. 2018 Jun;35(6):502-514. doi: 10.1002\u002Fda.22728. Epub 2018 Feb 16.",{"pmid":239,"type":236,"citation":240},"32914770","Cree RA, Okoro CA, Zack MM, Carbone E. Frequent Mental Distress Among Adults, by Disability Status, Disability Type, and Selected Characteristics - United States, 2018. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1238-1243. doi: 10.15585\u002Fmmwr.mm6936a2.",{"pmid":242,"type":236,"citation":243},"30994877","Cuijpers P, Noma H, Karyotaki E, Cipriani A, Furukawa TA. Effectiveness and Acceptability of Cognitive Behavior Therapy Delivery Formats in Adults With Depression: A Network Meta-analysis. JAMA Psychiatry. 2019 Jul 1;76(7):700-707. doi: 10.1001\u002Fjamapsychiatry.2019.0268.",{"pmid":245,"type":236,"citation":246},"36129711","Fan JQ, Lu WJ, Tan WQ, Liu X, Wang YT, Wang NB, Zhuang LX. Effectiveness of Acupuncture for Anxiety Among Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2232133. doi: 10.1001\u002Fjamanetworkopen.2022.32133.",{"pmid":248,"type":236,"citation":249},"14399272","HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136\u002Fjnnp.23.1.56. No abstract available.",{"pmid":251,"type":236,"citation":252},"33471111","Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001\u002Fjamapsychiatry.2020.4364.",{"pmid":254,"type":236,"citation":255},"37164067","Kavelaars R, Ward H, Mackie DS, Modi KM, Mohandas A. The burden of anxiety among a nationally representative US adult population. J Affect Disord. 2023 Sep 1;336:81-91. doi: 10.1016\u002Fj.jad.2023.04.069. Epub 2023 May 8.",{"pmid":257,"type":236,"citation":258},"31646432","Konnopka A, Konig H. Economic Burden of Anxiety Disorders: A Systematic Review and Meta-Analysis. Pharmacoeconomics. 2020 Jan;38(1):25-37. doi: 10.1007\u002Fs40273-019-00849-7.",{"pmid":260,"type":236,"citation":261},"32775969","Luo C, Sanger N, Singhal N, Pattrick K, Shams I, Shahid H, Hoang P, Schmidt J, Lee J, Haber S, Puckering M, Buchanan N, Lee P, Ng K, Sun S, Kheyson S, Chung DC, Sanger S, Thabane L, Samaan Z. A comparison of electronically-delivered and face to face cognitive behavioural therapies in depressive disorders: A systematic review and meta-analysis. EClinicalMedicine. 2020 Jun 27;24:100442. doi: 10.1016\u002Fj.eclinm.2020.100442. eCollection 2020 Jul.",{"pmid":263,"type":236,"citation":264},"27060430","Newby JM, Twomey C, Yuan Li SS, Andrews G. Transdiagnostic computerised cognitive behavioural therapy for depression and anxiety: A systematic review and meta-analysis. J Affect Disord. 2016 Jul 15;199:30-41. doi: 10.1016\u002Fj.jad.2016.03.018. Epub 2016 Mar 24.",{"pmid":266,"type":236,"citation":267},"34047264","Pauley D, Cuijpers P, Papola D, Miguel C, Karyotaki E. Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. Psychol Med. 2023 Jan;53(2):567-579. doi: 10.1017\u002FS0033291721001999. Epub 2021 May 28.",{"pmid":269,"type":236,"citation":270},"31753256","Zhao G, Okoro CA, Hsia J, Garvin WS, Town M. Prevalence of Disability and Disability Types by Urban-Rural County Classification-U.S., 2016. Am J Prev Med. 2019 Dec;57(6):749-756. doi: 10.1016\u002Fj.amepre.2019.07.022.",[272,275,278,281,284,287,290],{"label":273,"url":274},"American Psychological Association (2022), Healthcare Practitioner Survey","https:\u002F\u002Fwww.apa.org\u002Fpubs\u002Freports\u002Fpractitioner\u002F2022-covid-psychologist-workload",{"label":276,"url":277},"Driessen E, \\& Hollon SD. (2010). Cognitive behavioral therapy for mood disorders: Efficacy, moderators and mediators. Psychiatric Clinics of North America, 33(3), 537-55.","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC2933381\u002F",{"label":279,"url":280},"Guy W: Clinical Global Impression. ECDEU Assessment Manual for Psychopharmacology, revised National Institute of Mental Health, Rockville, MD. (1976)","https:\u002F\u002Fia800200.us.archive.org\u002F19\u002Fitems\u002Fecdeuassessmentm1933guyw\u002Fecdeuassessmentm1933guyw_bw.pdf",{"label":282,"url":283},"Hedeker, D. \\& Gibbons, R.D. (2006). Longitudinal data analysis. Hoboken, NJ: John Wiley \\& Sons, Inc.","https:\u002F\u002Fdownload.e-bookshelf.de\u002Fdownload\u002F0000\u002F5680\u002F60\u002FL-G-0000568060-0002356139.pdf",{"label":285,"url":286},"Hollander, M., Wolfe, D. A., \\& Chicken, E. (2013). Nonparametric statistical methods (3rd ed., pp. xiii, 819 pages). Hoboken, NJ: John Wiley \\& Sons, Inc.","https:\u002F\u002Fdownload.e-bookshelf.de\u002Fdownload\u002F0004\u002F0695\u002F89\u002FL-G-0004069589-0002628419.pdf",{"label":288,"url":289},"Pasquini, G and Keeter, S. (2022) At least four in ten U.S. adults have faced high levels of psychological distress during COVID-19 pandemic. Pew Research Center Reports December 12, 2022","https:\u002F\u002Fwww.pewresearch.org\u002Fshort-reads\u002F2022\u002F12\u002F12\u002Fat-least-four-in-ten-u-s-adults-have-faced-high-levels-of-psychological-distress-during-covid-19-pandemic\u002F",{"label":291,"url":292},"Van Buuren, S., and K. Groothuis-Oudshoorn (2011), mice: Multivariate Imputation by Chained Equations in R. Journal of Statistical Software, 45(3), 1-67.","https:\u002F\u002Fjeffgill.org\u002Fwp-content\u002Fuploads\u002F2021\u002F04\u002Fmice_multivariate_imputation_by_chained_equations.pdf",{"nct_id":4,"conditions":294,"biomarkers":297},[295,20,296],"Ability to mobilize","Learning disability",[],{"nct_id":4,"found":299,"summary":300,"prompt_version":310},true,{"design":301,"status":302,"heading":303,"summary":304,"follow_up":305,"word_count":306,"commitments":307,"compensation":308,"drugs_mentioned":309},"This is a randomized clinical trial with two groups, meaning participants will be randomly assigned to either the Toivoa-002 program or the general health program. The study plans to enroll 200 participants.","completed","Digital CBT and Coaching for Depression in People with Disabilities","This study is testing if a mobile program called Toivoa-002 can help reduce depression in adults with hearing or mobility disabilities. Toivoa-002 combines digital cognitive behavioral therapy (CBT), a type of talk therapy, with personal coaching from a National Board Health and Wellness Coach (NBHWC). We want to see if Toivoa-002 works better than a similar-looking digital program that offers general health information but no depression treatment. To join, you need to be at least 22 years old, have a self-reported hearing or mobility disability, and have a diagnosis of depression with a specific score on a depression scale (HAM-D score of 17 or higher). The main goal is to see how much depression symptoms improve after 8 weeks. The study plans to enroll 200 people, but its current status is unclear.","Your depression symptoms will be checked again at 12 weeks after the start of the study to see if the benefits last.",132,"You would participate in the digital program for 8 weeks and be available for the duration of the study.","Not stated in the trial record.",[],"v2"]