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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.

Conditions
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Depression, Chronic Disease (Diabetes/Low Back Pain)

Intervention / Treatment
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* Behavioral: Low intensity Internet-delivered psychotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low intensity Internet-delivered psychotherapy<br>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). | Behavioral: Low intensity Internet-delivered psychotherapy<br>* 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<br>|
| No Intervention: Improved Treatment-as-usual (TAU)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | In the Intervention group. The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | Baseline | 
| Patient Health Questionnaire (PHQ-9) | In the TAU control group. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | Baseline | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | Post-treatment 8-12 weeks from baseline in the intervention group | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | Post-treatment 8-12 weeks from baseline in the TAU control group | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | 3 months follow up in the intervention group | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | 3 months follow up in the TAU control group | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27. | 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) | In the Intervention group | Baseline | 
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) | In the TAU control group | Baseline | 
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) |  | Post-treatment 8-12 weeks from baseline in the intervention group | 
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) |  | Post-treatment 8-12 weeks from baseline in the TAU control group | 
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) |  | 3 months follow up in the intervention group | 
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) |  | 3 months follow up in the TAU control group | 
| Roland Morris Disability Questionnaire (RMDQ) | In the Intervention group. The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | Baseline | 
| Roland Morris Disability Questionnaire (RMDQ) | In the TAU control group. The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | Baseline | 
| Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | Post-treatment 8-12 weeks from baseline in the intervention group | 
| Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | Post-treatment 8-12 weeks from baseline in the TAU control group | 
| Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | 3 months follow up in the intervention group | 
| Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability). | 3 months follow up in the TAU control group | 
| Diabetes control measured by VR d= Hb glucosidal | In the Intervention group | Baseline | 
| Diabetes control measured by VR d= Hb glucosidal | In the TAU control group | Baseline | 
| Diabetes control measured by VR d= Hb glucosidal |  | Post-treatment 8-12 weeks from baseline in the intervention group | 
| Diabetes control measured by VR d= Hb glucosidal |  | Post-treatment 8-12 weeks from baseline in the TAU control group | 
| Diabetes control measured by VR d= Hb glucosidal |  | 3 months follow up in the intervention group | 
| Diabetes control measured by VR d= Hb glucosidal |  | 3 months follow up in the TAU control group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the Intervention group and the TAU control group | Baseline | 
| The Mini-International Neuropsychiatric Interview (MINI) | In the Intervention group and the TAU control group. This is a short structured diagnostic psychiatric interview that yields key DSM-IV and ICD-10 diagnoses. MINI can be administered in a short period of time and clinical interviewers need only a brief training. The MINI has been translated and validated in Spanish. | Baseline | 
| Health Survey 12 (SF-12) | In the Intervention group | Baseline | 
| Health Survey 12 (SF-12) | In the TAU control group | Baseline | 
| Health Survey 12 (SF-12) |  | Post-treatment 12 weeks from baseline in the intervention group | 
| Health Survey 12 (SF-12) |  | Post-treatment 12 weeks from baseline in the TAU control group | 
| Health Survey 12 (SF-12) |  | 3 months follow up in the intervention group | 
| Health Survey 12 (SF-12) |  | 3 months follow up in the TAU control group | 
| Client Service Receipt Inventory (CSRI) | In the Intervention group | Baseline | 
| Client Service Receipt Inventory (CSRI) | In the TAU control group | Baseline | 
| Client Service Receipt Inventory (CSRI) |  | Post-treatment 12 weeks from baseline in the intervention group | 
| Client Service Receipt Inventory (CSRI) |  | Post-treatment 12 weeks from baseline in the TAU control group | 
| Client Service Receipt Inventory (CSRI) |  | 3 months follow up in the intervention group | 
| Client Service Receipt Inventory (CSRI) |  | 3 months follow up in the TAU control group | 
| Positive and Negative Affect Schedule (PANAS) | The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., interested, and 10 negative: e.g., guilty) that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999). | Baseline in the intervention group and TAU control group | 
| Positive and Negative Affect Schedule (PANAS) | The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., interested, and 10 negative: e.g., guilty) that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999). | 3 months follow up in the intervention group and TAU control group | 
| Positive and Negative Affect Schedule (PANAS) | The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., interested, and 10 negative: e.g., guilty) that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999). | Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months). | 
| Positive and Negative Affect Schedule (PANAS) | The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., interested, and 10 negative: e.g., guilty) that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999). | Post-treatment 12 weeks from baseline in the intervention and TAU control group | 
| Usefulness | A single question about usefulness (i.e., To what extent has this module been useful to you? (Lopez-Montoyo et al., 2019); with a Likert-type response option that ranges between 0 = nothing and 10 = very much). | Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months). | 
| System Usability Scale (SUS) | The SUS is a 10-item questionnaire that measures usability in relation to the quality and acceptability of the intervention (i.e., I think that I would like to use this system frequently; with a Likert-type response option that ranges between 1 = strongly disagree and 5 = strongly agree) (Bangor et al., 2008). | Post module 1 (Psychoeducation) after an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Multimorbidity, Computer-delivered psychotherapy, Randomized-controlled trial, Cost-effectiveness