- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03068676
Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)
A Pilot Study Investigating the Feasibility of Implementing Internet-delivered Treatments for Depression and Anxiety in Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety. Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered with poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option.
Approximately 90% of primary care patients with depression have one or more visits to a primary care physician (PCP) over a 12-month period, whereas less than one-third see a mental health professional. It has been reported that individuals with an anxiety disorder are 3 to 5 times more likely to visit their primary care physician than those without, but their symptoms are often associated with physical causes. PCPs often do not have training in psychological therapies and therefore they do not feel competent to treat individuals presenting with depression or anxiety. Often these individuals are prescribed antidepressant or anti-anxiety medications.
The use of online programs to deliver CBT to people with mental health disorders is becoming increasingly popular. Internet-delivered CBT (iCBT) consists of programs designed for the treatment of specific disorders, such as depression and anxiety, which are delivered via the internet. These programs can be clinician-guided and/or self-administered interventions. Evidence suggests that iCBT can benefit individuals with anxiety and depression when offered in a service context that offers brief support from trained staff. Such iCBT interventions are widely-used in some European countries and the recommended length of treatment is generally 6 - 8 online sessions. A robust evidence base supporting the use and effectiveness of internet-delivered treatments for depression and anxiety has been established. Outcomes have been greater for those programs offering the additional feature of human support.
The current study will examine the feasibility of implementing an iCBT platform within a primary care setting. This objective can be further dismantled into several sub objectives:
- Is the model of implementation (screening, recruitment, and adherence to the internet-delivered intervention) feasible?
- Will patients experience the iCBT intervention as satisfactory within their primary care treatment?
- What is the feedback of the Primary Care Practitioners about the implementation of the internet-delivered intervention as part of primary care?
- What is the experience of the trained supporters who assist patients within the iCBT intervention?
- Can an internet-delivered intervention achieve improvements in depressive and anxiety symptoms for users?
- Can patient attitudes toward internet-delivered interventions predict treatment outcome?
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Akron, Ohio, Estados Unidos, 44310
- Summa Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
At least 18 years of age, Speak English, Self-report symptoms of depression or anxiety (using PHQ-9 and GAD-7 measures).
Specifically for the self-report symptoms,
participants will need to have a PHQ-9 score of 5 to 19 for the depression program or a GAD-7 score of 5 to 15 for the anxiety program.
Participants currently attending face-to-face therapy/counseling will be excluded.
Exclusion criteria
Participants who flag as a risk on the self-harm item of the PHQ-9 during routine office visit screening will not be referred to the study and will be provided treatment and/or referral services as per the clinic's standard procedure.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Space from depression
Space from Depression is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs.
Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries.
In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
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internet-delivered CBT
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Experimental: Space from Anxiety
Space from Anxiety is an eight-module online CBT-based intervention for depression, composed of cognitive and behavioral components including self-monitoring and thought recording, behavioral activation, cognitive restructuring, and challenging core beliefs.
Each module follows a structured format that incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries.
In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
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internet-delivered CBT
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient health Questionnaire
Periodo de tiempo: At week 8
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The PHQ-9 is a self-report measure of depression that has been widely used in screening, primary care, and research.
The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association [APA], 2000).
Summed scores range from 0-27; larger scores reflect a greater severity of depressive symptoms.
The PHQ-9 discriminated well between depressed and nondepressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%) and specificity (88.0%) (Kroenke et al., 2001; R. Spitzer et al., 1999).
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At week 8
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Generalized Anxiety Disorder
Periodo de tiempo: At week 8
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The GAD-7 (Spitzer, Krownke, Williams, & Lowe, 2006) comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD.
The GAD-7 has good internal consistency (.89) and good convergent validity with other anxiety scales.
Higher scores indicate greater severity of symptoms.
The GAD-7 is increasingly used in large-scale studies as a generic measure of changes in anxiety symptomatology, using a cut-off score of 8 (Richards & Suckling, 2009).
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At week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Socio-demographic Questionnaire
Periodo de tiempo: At baseline for screening
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Collects information on the characteristics of the sample including age, gender etc.
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At baseline for screening
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Work and Social Adjustment
Periodo de tiempo: At baseline and week 8
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The Work and Social Adjustment (WASA; Mundt, Marks, Shear, & Greist, 2002) is a simple, reliable and valid measure of impaired functioning.
It is a simple and reliable (α >.75) 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view.
It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships.
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At baseline and week 8
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Satisfaction with Treatment
Periodo de tiempo: At week 8
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The Satisfaction with Treatment (SAT; Timulak & Richards, 2012) measure contains several questions that aim to assess patient satisfaction with the iCBT intervention received.
The measure consists of 2 qualitative questions and several quantitative questions, centring on what the patients liked or disliked about the iCBT intervention.
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At week 8
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Attitudes towards Psychological Online Interventions
Periodo de tiempo: At baseline and week 8
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The Attitudes towards Psychological Online Interventions (APOI; Schroder et al., 2015) will be administered to patients at both pre and post intervention time points.
The APOI is a brief inventory that assesses attitudes towards online interventions across four domains - scepticism and perception of risks, confidence in effectiveness, technologization threat and anonymity benefits.
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At baseline and week 8
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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/j.1525-1497.2001.016009606.x.
- Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
- Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
- 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/archinte.166.10.1092.
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56.
- Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629-40. doi: 10.1001/archpsyc.62.6.629.
- Richards DA, Suckling R. Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol. 2009 Nov;48(Pt 4):377-96. doi: 10.1348/014466509X405178. Epub 2009 Feb 9.
- Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109.
- Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20.
- Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
- Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21.
- Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14.
- Stein MB, McQuaid JR, Pedrelli P, Lenox R, McCahill ME. Posttraumatic stress disorder in the primary care medical setting. Gen Hosp Psychiatry. 2000 Jul-Aug;22(4):261-9. doi: 10.1016/s0163-8343(00)00080-3.
- Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, Reifler D. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010 Apr;66(4):394-409. doi: 10.1002/jclp.20659.
- Coyne JC, Fechner-Bates S, Schwenk TL. Prevalence, nature, and comorbidity of depressive disorders in primary care. Gen Hosp Psychiatry. 1994 Jul;16(4):267-76. doi: 10.1016/0163-8343(94)90006-x.
- Goldman LS, Nielsen NH, Champion HC. Awareness, diagnosis, and treatment of depression. J Gen Intern Med. 1999 Sep;14(9):569-80. doi: 10.1046/j.1525-1497.1999.03478.x.
- Hedman E, Ljotsson B, Lindefors N. Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):745-64. doi: 10.1586/erp.12.67.
- Katon WJ, Roy-Byrne P, Russo J, Cowley D. Cost-effectiveness and cost offset of a collaborative care intervention for primary care patients with panic disorder. Arch Gen Psychiatry. 2002 Dec;59(12):1098-104. doi: 10.1001/archpsyc.59.12.1098.
- Khouzam, H. R. (2009). Anxiety Disorders: Guidelines for Effective Primary Care, Part 1, Diagnosis. Consultant, 49 (3).
- Lecrubier Y, Weiller E. Characteristics, recognition and treatment of dysthymics in primary care. Eur Psychiatry. 1998 Jul;13(4):198-202. doi: 10.1016/S0924-9338(98)80004-7.
- Lepine JP. The epidemiology of anxiety disorders: prevalence and societal costs. J Clin Psychiatry. 2002;63 Suppl 14:4-8.
- Lyness JM, Caine ED, King DA, Cox C, Yoediono Z. Psychiatric disorders in older primary care patients. J Gen Intern Med. 1999 Apr;14(4):249-54. doi: 10.1046/j.1525-1497.1999.00326.x.
- Schulberg HC, Mulsant B, Schulz R, Rollman BL, Houck PR, Reynolds CF 3rd. Characteristics and course of major depression in older primary care patients. Int J Psychiatry Med. 1998;28(4):421-36. doi: 10.2190/G23R-NGGN-K1P1-MQ8N.
- Sheehan DV. Depression: underdiagnosed, undertreated, underappreciated. Manag Care. 2004 Jun;13(6 Suppl Depression):6-8.
- Simon GE, Goldberg D, Tiemens BG, Ustun TB. Outcomes of recognized and unrecognized depression in an international primary care study. Gen Hosp Psychiatry. 1999 Mar-Apr;21(2):97-105. doi: 10.1016/s0163-8343(98)00072-3.
- Vermani M, Marcus M, Katzman MA. Rates of detection of mood and anxiety disorders in primary care: a descriptive, cross-sectional study. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01013. doi: 10.4088/PCC.10m01013.
- Williams JW Jr, Mulrow CD, Kroenke K, Dhanda R, Badgett RG, Omori D, Lee S. Case-finding for depression in primary care: a randomized trial. Am J Med. 1999 Jan;106(1):36-43. doi: 10.1016/s0002-9343(98)00371-4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SUMMA-PC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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