Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT03426709
• Date of registration: 02/02/2018
• Prospective Registration: Yes
• Primary sponsor: Javier Garcia Campayo
• Public title: Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.
• Scientific title: Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.
• Date of first enrolment: November 26, 2018
• Target sample size: 196
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03426709
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Javier García-Campayo
• Affiliation: Miguel Servet Hospital and University os Zaragoza, Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Chronic Disease (Diabetes/Low Back Pain)

Intervention(s)

Behavioral: Low intensity Internet-delivered psychotherapy

Primary Outcome(s)

Diabetes control measured by VR d= Hb glucosidal [Time Frame: Baseline]

Diabetes control measured by VR d= Hb glucosidal [Time Frame: Post-treatment 8-12 weeks from baseline in the TAU control group]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: 3 months follow up in the intervention group]

Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [Time Frame: Post-treatment 8-12 weeks from baseline in the intervention group]

Patient Health Questionnaire (PHQ-9) [Time Frame: Baseline]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: Baseline]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: Post-treatment 8-12 weeks from baseline in the intervention group]

Diabetes control measured by VR d= Hb glucosidal [Time Frame: 3 months follow up in the intervention group]

Patient Health Questionnaire (PHQ-9) [Time Frame: Post-treatment 8-12 weeks from baseline in the intervention group]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: Post-treatment 8-12 weeks from baseline in the TAU control group]

Diabetes control measured by VR d= Hb glucosidal [Time Frame: Post-treatment 8-12 weeks from baseline in the intervention group]

Patient Health Questionnaire (PHQ-9) [Time Frame: 3 months follow up in the intervention group]

Patient Health Questionnaire (PHQ-9) [Time Frame: 3 months follow up in the TAU control group]

Patient Health Questionnaire (PHQ-9) [Time Frame: Post-treatment 8-12 weeks from baseline in the TAU control group]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: 3 months follow up in the TAU control group]

Diabetes control measured by VR d= Hb glucosidal [Time Frame: 3 months follow up in the TAU control group]

Patient Health Questionnaire (PHQ-9) [Time Frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).]

Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [Time Frame: 3 months follow up in the intervention group]

Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [Time Frame: 3 months follow up in the TAU control group]

Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [Time Frame: Baseline]

Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [Time Frame: Post-treatment 8-12 weeks from baseline in the TAU control group]

Secondary Outcome(s)

Client Service Receipt Inventory (CSRI) [Time Frame: Post-treatment 12 weeks from baseline in the intervention group]

Health Survey 12 (SF-12) [Time Frame: Post-treatment 12 weeks from baseline in the intervention group]

Usefulness [Time Frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).]

Client Service Receipt Inventory (CSRI) [Time Frame: Post-treatment 12 weeks from baseline in the TAU control group]

Positive and Negative Affect Schedule (PANAS) [Time Frame: Baseline in the intervention group and TAU control group]

System Usability Scale (SUS) [Time Frame: Post module 1 (Psychoeducation) after an average of 1 week]

Positive and Negative Affect Schedule (PANAS) [Time Frame: 3 months follow up in the intervention group and TAU control group]

Positive and Negative Affect Schedule (PANAS) [Time Frame: Post-treatment 12 weeks from baseline in the intervention and TAU control group]

Health Survey 12 (SF-12) [Time Frame: 3 months follow up in the TAU control group]

Health Survey 12 (SF-12) [Time Frame: Post-treatment 12 weeks from baseline in the TAU control group]

Client Service Receipt Inventory (CSRI) [Time Frame: 3 months follow up in the intervention group]

Client Service Receipt Inventory (CSRI) [Time Frame: 3 months follow up in the TAU control group]

Client Service Receipt Inventory (CSRI) [Time Frame: Baseline]

Positive and Negative Affect Schedule (PANAS) [Time Frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).]

Health Survey 12 (SF-12) [Time Frame: Baseline]

Sociodemographic data Gender, age, marital status, education, occupation, economical level [Time Frame: Baseline]

Health Survey 12 (SF-12) [Time Frame: 3 months follow up in the intervention group]

The Mini-International Neuropsychiatric Interview (MINI) [Time Frame: Baseline]

Secondary ID(s)

PI16/00962

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Carlos III Health Institute