Clinical trial NCT03426709: Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.
Official title: Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Chronic Disease (Diabetes/Low Back Pain)
Keywords: Depression
Multimorbidity
Computer-delivered psychotherapy
Randomized-controlled trial
Cost-effectiveness
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2018-02-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment.

Detailed description: Although multimorbidity is highly prevalent, health care systems are designed for the management individual diseases. New strategies are needed to help general practitioners to provide appropriate personalized care to patients. The World Health Organization (WHO) has included comorbidity between depression and a chronic disease as one of the 10 main priorities in global public health. Studies in meta-analysis confirm that the 2 main interventions of first choice for depression are pharmacotherapy and/or psychotherapy, with similar results in the short term but superior in the long term for psychological treatments. Given the difficulty of delivering face to face psychological treatments (high costs) alternative models of delivering treatments have been proposed, emphasizing the role of technologies like Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention (8 weeks) applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment. A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). 180 participants diagnosed with depression and diabetes/low back pain will participate in the RCT. It´s proposed a coordinated study by 4 highly experienced groups with great possibilities of translation and transference to usual clinical practice.

Eligibility criteria: Inclusion Criteria:

* Be adult
* 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:

* Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
* 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post-treatment 8-12 weeks from baseline in the intervention group
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post-treatment 8-12 weeks from baseline in the TAU control group
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months follow up in the intervention group
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months follow up in the TAU control group
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: Baseline
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: Baseline
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: Post-treatment 8-12 weeks from baseline in the intervention group
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: Post-treatment 8-12 weeks from baseline in the TAU control group
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: 3 months follow up in the intervention group
measure: Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
timeFrame: 3 months follow up in the TAU control group
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Post-treatment 8-12 weeks from baseline in the intervention group
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Post-treatment 8-12 weeks from baseline in the TAU control group
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 3 months follow up in the intervention group
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 3 months follow up in the TAU control group
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: Baseline
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: Baseline
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: Post-treatment 8-12 weeks from baseline in the intervention group
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: Post-treatment 8-12 weeks from baseline in the TAU control group
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: 3 months follow up in the intervention group
measure: Diabetes control measured by VR d= Hb glucosidal
timeFrame: 3 months follow up in the TAU control group
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: The Mini-International Neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Health Survey 12 (SF-12)
timeFrame: Baseline
measure: Health Survey 12 (SF-12)
timeFrame: Baseline
measure: Health Survey 12 (SF-12)
timeFrame: Post-treatment 12 weeks from baseline in the intervention group
measure: Health Survey 12 (SF-12)
timeFrame: Post-treatment 12 weeks from baseline in the TAU control group
measure: Health Survey 12 (SF-12)
timeFrame: 3 months follow up in the intervention group
measure: Health Survey 12 (SF-12)
timeFrame: 3 months follow up in the TAU control group
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Post-treatment 12 weeks from baseline in the intervention group
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Post-treatment 12 weeks from baseline in the TAU control group
measure: Client Service Receipt Inventory (CSRI)
timeFrame: 3 months follow up in the intervention group
measure: Client Service Receipt Inventory (CSRI)
timeFrame: 3 months follow up in the TAU control group
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline in the intervention group and TAU control group
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 3 months follow up in the intervention group and TAU control group
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Post-treatment 12 weeks from baseline in the intervention and TAU control group
measure: Usefulness
timeFrame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).
measure: System Usability Scale (SUS)
timeFrame: Post module 1 (Psychoeducation) after an average of 1 week
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Health Science Research Institute, University Balearic Islands
state: Mallorca
city: Málaga
country: Spain
facility: Psychiatric Service. University Hospital Carlos Haya
city: Valencia
country: Spain
facility: Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet Hospital and University os Zaragoza, Spain
name: Javier García-Campayo
role: PRINCIPAL_INVESTIGATOR
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