Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low intensity Internet-delivered psychotherapy
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).
干预措施: Low intensity Internet-delivered psychotherapy (Behavioral)
Improved Treatment-as-usual (TAU)
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.
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).
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.
Roland Morris Disability Questionnaire (RMDQ)
时间窗: 3 months follow up 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).
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
时间窗: 3 months follow up in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
时间窗: 3 months follow up in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
时间窗: 3 months follow up in the intervention group
Diabetes control measured by VR d= Hb glucosidal
时间窗: Baseline
In the Intervention group
Diabetes control measured by VR d= Hb glucosidal
时间窗: Post-treatment 8-12 weeks from baseline in the intervention group
Patient Health Questionnaire (PHQ-9)
时间窗: 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.
Patient Health Questionnaire (PHQ-9)
时间窗: Post-treatment 8-12 weeks from baseline in the intervention 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.
Patient Health Questionnaire (PHQ-9)
时间窗: Post-treatment 8-12 weeks from baseline 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.
Diabetes control measured by VR d= Hb glucosidal
时间窗: Post-treatment 8-12 weeks from baseline in the TAU control group
Patient Health Questionnaire (PHQ-9)
时间窗: 3 months follow up in the intervention 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.
Patient Health Questionnaire (PHQ-9)
时间窗: 3 months follow up 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.
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
时间窗: Baseline
In the Intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
时间窗: Post-treatment 8-12 weeks from baseline in the intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
时间窗: Post-treatment 8-12 weeks from baseline in the TAU control group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
时间窗: 3 months follow up in the intervention group
Roland Morris Disability Questionnaire (RMDQ)
时间窗: 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).
Roland Morris Disability Questionnaire (RMDQ)
时间窗: Post-treatment 8-12 weeks from 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).
Roland Morris Disability Questionnaire (RMDQ)
时间窗: Post-treatment 8-12 weeks from baseline 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).
Roland Morris Disability Questionnaire (RMDQ)
时间窗: 3 months follow up 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).
次要结局
- The Mini-International Neuropsychiatric Interview (MINI)(Baseline)
- Usefulness(Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).)
- Sociodemographic data Gender, age, marital status, education, occupation, economical level(Baseline)
- Health Survey 12 (SF-12)(3 months follow up in the TAU control group)
- Client Service Receipt Inventory (CSRI)(3 months follow up in the TAU control group)
- Positive and Negative Affect Schedule (PANAS)(Post-treatment 12 weeks from baseline in the intervention and TAU control group)
- System Usability Scale (SUS)(Post module 1 (Psychoeducation) after an average of 1 week)
- 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)
- Client Service Receipt Inventory (CSRI)(3 months follow up in the intervention group)
- Health Survey 12 (SF-12)(Baseline)
- Client Service Receipt Inventory (CSRI)(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)
- Positive and Negative Affect Schedule (PANAS)(Baseline in the intervention group and TAU control group)
- Positive and Negative Affect Schedule (PANAS)(3 months follow up in the intervention group and TAU control group)
- Positive and Negative Affect Schedule (PANAS)(Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).)
研究者
Javier Garcia Campayo
Principal investigator
Hospital Miguel Servet