Chronic Disease (Diabetes/Low Back Pain), Depression
Conditions
Keywords
Depression, Multimorbidity, Computer-delivered psychotherapy, Randomized-controlled trial, Cost-effectiveness
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.
Interventions
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
Sponsors
Carlos III Health Institute
Javier Garcia Campayo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | Baseline | 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. |
| Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) | Baseline | In the Intervention group |
| Roland Morris Disability Questionnaire (RMDQ) | Baseline | 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). |
| Diabetes control measured by VR d= Hb glucosidal | Baseline | In the Intervention group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Schedule (PANAS) | Baseline in the intervention group and TAU control group | 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). |
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | Baseline | In the Intervention group and the TAU control group |
| System Usability Scale (SUS) | Post module 1 (Psychoeducation) after an average of 1 week | 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). |
| Usefulness | Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months). | 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). |
| The Mini-International Neuropsychiatric Interview (MINI) | Baseline | 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. |
| Health Survey 12 (SF-12) | Baseline | In the Intervention group |
| Client Service Receipt Inventory (CSRI) | Baseline | In the Intervention group |
Countries
Spain
Outcome results
None listed