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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
In the Intervention group
Time frame: Baseline
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
In the TAU control group
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 intervention group
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
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 3 months follow up in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
In the Intervention group
Time frame: Baseline
Diabetes control measured by VR d= Hb glucosidal
In the TAU control group
Time frame: Baseline
Diabetes control measured by VR d= Hb glucosidal
Time frame: Post-treatment 8-12 weeks from baseline in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
Time frame: 3 months follow up in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Time frame: 3 months follow up in the TAU control group
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the Intervention group and the TAU control group
Time frame: 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.
Time frame: Baseline
Health Survey 12 (SF-12)
In the Intervention group
Time frame: Baseline
Health Survey 12 (SF-12)
In the TAU control group
Time frame: Baseline
Health Survey 12 (SF-12)
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 TAU control group
Health Survey 12 (SF-12)
Time frame: 3 months follow up in the intervention group
Health Survey 12 (SF-12)
Time frame: 3 months follow up in the TAU control group
Client Service Receipt Inventory (CSRI)
In the Intervention group
Time frame: Baseline
Client Service Receipt Inventory (CSRI)
In the TAU control group
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Time frame: Baseline
Client Service Receipt Inventory (CSRI)
Time frame: Post-treatment 12 weeks from baseline in the intervention group
Client Service Receipt Inventory (CSRI)
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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").
Time frame: 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).
Time frame: Post module 1 (Psychoeducation) after an average of 1 week