Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.
NCT ID: NCT03426709
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
196 participants
INTERVENTIONAL
2018-11-26
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low intensity Internet-delivered psychotherapy
improved Treatment-as-usual (TAU) + face to face (2 sessions of 90 minutes/session) + low intensity psychological intervention (6 sessions of 60 minutes/session) applied by ICTs (Information and communication technologies).
Low intensity Internet-delivered psychotherapy
The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the program is 8 weeks. Low Intensity Internet-delivered psychotherapy: Psychoeducation, Healthy living habits, Behavioral activation, Positive Psychology, Mindfulness and Compassion
Improved Treatment-as-usual (TAU)
In this group, the general practitioner (GP) will apply the usual but improved treatment. The GP will have a training meeting and will be provided with the recommendations of one of the Guidelines for the Treatment of Adult Depression in AP most used in our country.
No interventions assigned to this group
Interventions
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Low intensity Internet-delivered psychotherapy
The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the program is 8 weeks. Low Intensity Internet-delivered psychotherapy: Psychoeducation, Healthy living habits, Behavioral activation, Positive Psychology, Mindfulness and Compassion
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in the study and signing informed consent
* Ability to understand oral and written Spanish.
* DSM-5 diagnose of Major Depression or Dysthymia, mild or moderate depression expressed as score lower than 19 in the Patient Health Questionnaire (PHQ-9)
* Duration of depressive symptoms 2 months or more
* Diagnosis of one of the following two conditions: Diabetes (Diagnosis according to criteria of the American Diabetes Association (ADA)) or low back pain (Diagnosis of non-specific chronic low back pain according to the definition established by the Clinical Practice Guide of the European Program COST B-13 (CPG COST B-13) with a duration of at least 6 months)
* To have and to handle the computer, internet and mobile phone
Exclusion Criteria
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.), except for anxious pathology or personality disorders
* Any medical, infectious or degenerative disease that may affect mood
* Presence of delusional ideas or hallucinations consistent or not with mood
* Suicide risk
18 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Javier Garcia Campayo
OTHER
Responsible Party
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Javier Garcia Campayo
Principal investigator
Principal Investigators
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Javier García-Campayo
Role: PRINCIPAL_INVESTIGATOR
Miguel Servet Hospital and University os Zaragoza, Spain
Locations
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Health Science Research Institute, University Balearic Islands
Palma de Mallorca, Mallorca, Spain
Psychiatric Service. University Hospital Carlos Haya
Málaga, , Spain
Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
Valencia, , Spain
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, , Spain
Countries
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References
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Bogner HR, de Vries HF. Integration of depression and hypertension treatment: a pilot, randomized controlled trial. Ann Fam Med. 2008 Jul-Aug;6(4):295-301. doi: 10.1370/afm.843.
Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
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.
Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181-4. doi: 10.1192/bjp.bp.106.025981.
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.
Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.
Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol. 2004 Mar;57(3):268-76. doi: 10.1016/j.jclinepi.2003.09.005.
Stratford PW, Binkley J, Solomon P, Finch E, Gill C, Moreland J. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther. 1996 Apr;76(4):359-65; discussion 366-8. doi: 10.1093/ptj/76.4.359.
Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.
Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.
Ferrando L, Bobes J, Gilbert J, Soto M, Soto O. MINI: MINI International Neuropsychiatric Interview, Madrid, IAP, 1998.
Beecham JK, et al. Costing psychiatric interventions. In: Thornicroft G, ed. Measuring mental health needs. London: Royal College of Psychiatrists; 2001; 200-224.
Vazquez-Barquero JL. et al. Spanish version of the CSRI: a mental health cost evauation interview. Arch Neurobol, 1997; 60: 171-84.
Monreal-Bartolome A, Castro A, Perez-Ara MA, Gili M, Mayoral F, Hurtado MM, Varela Moreno E, Botella C, Garcia-Palacios A, Banos RM, Lopez-Del-Hoyo Y, Garcia-Campayo J, Montero-Marin J. Efficacy of a Blended Low-Intensity Internet-Delivered Psychological Program in Patients With Multimorbidity in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2025 Feb 10;27:e56203. doi: 10.2196/56203.
Varela-Moreno E, Anarte-Ortiz MT, Jodar-Sanchez F, Garcia-Palacios A, Monreal-Bartolome A, Gili M, Garcia-Campayo J, Mayoral-Cleries F. Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 May 16;12:e55483. doi: 10.2196/55483.
Monreal-Bartolome A, Barcelo-Soler A, Castro A, Perez-Ara MA, Gili M, Mayoral F, Hurtado MM, Moreno EV, Botella C, Garcia-Palacios A, Banos RM, Lopez-Del-Hoyo Y, Garcia-Campayo J. Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial. BMC Psychiatry. 2019 Feb 11;19(1):66. doi: 10.1186/s12888-019-2037-3.
Related Links
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Official website of the Spanish Research Network in Primary Care (Rediapp)
Other Identifiers
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PI16/00962
Identifier Type: -
Identifier Source: org_study_id
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