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

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ClinicalTrials.gov Identifier: NCT03426709
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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 six months after the end of treatment.

Condition or disease Intervention/treatment Phase
Depression Chronic Disease (Diabetes/Low Back Pain) Behavioral: Low intensity Internet-delivered psychotherapy Not Applicable

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 six 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). 300 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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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) in groups of 8-12 people.
Behavioral: Low intensity Internet-delivered psychotherapy
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

No Intervention: 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.



Primary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.

  3. Patient Health Questionnaire (PHQ-9) [ Time Frame: Post-treatment 8 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.

  4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Post-treatment 8 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.

  5. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.

  6. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.

  7. Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 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.

  8. Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months follow up in the TAU control group ]
    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.

  9. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: Baseline ]
    In the Intervention group

  10. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: Baseline ]
    In the TAU control group

  11. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: Post-treatment 8 weeks from baseline in the intervention group ]
  12. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: Post-treatment 8 weeks from baseline in the TAU control group ]
  13. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: 3 months follow up in the intervention group ]
  14. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: 3 months follow up in the TAU control group ]
  15. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: 6 months follow up in the intervention group ]
  16. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10) [ Time Frame: 6 months follow up in the TAU control group ]
  17. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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).

  18. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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).

  19. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Post-treatment 8 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).

  20. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Post-treatment 8 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).

  21. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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).

  22. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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).

  23. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 6 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).

  24. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 6 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).

  25. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: Baseline ]
    In the Intervention group

  26. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: Baseline ]
    In the TAU control group

  27. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: Post-treatment 8 weeks from baseline in the intervention group ]
  28. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: Post-treatment 8 weeks from baseline in the TAU control group ]
  29. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: 3 months follow up in the intervention group ]
  30. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: 3 months follow up in the TAU control group ]
  31. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: 6 months follow up in the intervention group ]
  32. Diabetes control measured by VR d= Hb glucosidal [ Time Frame: 6 months follow up in the TAU control group ]

Secondary Outcome Measures :
  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the Intervention group and the TAU control group

  2. The Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: 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.

  3. Health Survey 12 (SF-12) [ Time Frame: Baseline ]
    In the Intervention group

  4. Health Survey 12 (SF-12) [ Time Frame: Baseline ]
    In the TAU control group

  5. Health Survey 12 (SF-12) [ Time Frame: Post-treatment 8 weeks from baseline in the intervention group ]
  6. Health Survey 12 (SF-12) [ Time Frame: Post-treatment 8 weeks from baseline in the TAU control group ]
  7. Health Survey 12 (SF-12) [ Time Frame: 3 months follow up in the intervention group ]
  8. Health Survey 12 (SF-12) [ Time Frame: 3 months follow up in the TAU control group ]
  9. Health Survey 12 (SF-12) [ Time Frame: 6 months follow up in the intervention group ]
  10. Health Survey 12 (SF-12) [ Time Frame: 6 months follow up in the TAU control group ]
  11. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the Intervention group

  12. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline ]
    In the TAU control group

  13. Client Service Receipt Inventory (CSRI) [ Time Frame: Post-treatment 8 weeks from baseline in the intervention group ]
  14. Client Service Receipt Inventory (CSRI) [ Time Frame: Post-treatment 8 weeks from baseline in the TAU control group ]
  15. Client Service Receipt Inventory (CSRI) [ Time Frame: 3 months follow up in the intervention group ]
  16. Client Service Receipt Inventory (CSRI) [ Time Frame: 3 months follow up in the TAU control group ]
  17. Client Service Receipt Inventory (CSRI) [ Time Frame: 6 months follow up in the intervention group ]
  18. Client Service Receipt Inventory (CSRI) [ Time Frame: 6 months follow up in the TAU control group ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 14 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426709


Contacts
Contact: Javier García-Campayo +34976765500 jgarcamp@gmail.com

Locations
Spain
Health Science Research Institute, University Balearic Islands Recruiting
Palma de Mallorca, Mallorca, Spain
Principal Investigator: Miquel Roca         
Principal Investigator: Margarida Gili         
Psychiatric Service. University Hospital Carlos Haya Recruiting
Málaga, Spain, 29010
Principal Investigator: Mayoral Fermín         
Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute Active, not recruiting
Valencia, Spain
Department of Psychiatry. Miguel Servet University Hospital Recruiting
Zaragoza, Spain, 50009
Principal Investigator: Javier García         
Sponsors and Collaborators
Javier Garcia Campayo
Carlos III Health Institute
Investigators
Principal Investigator: Javier García-Campayo Miguel Servet Hospital and University os Zaragoza, Spain

Additional Information:
Publications:
Ferrando L, Bobes J, Gilbert J, Soto M, Soto O. MINI: MINI International Neuropsychiatric Interview, Madrid, IAP, 1998.
Beecham JK, et al. Costing psychiatric interventions. In: Thornicroft G, ed. Measuring mental health needs. London: Royal College of Psychiatrists; 2001; 200-224.
Vazquez-Barquero JL. et al. Spanish version of the CSRI: a mental health cost evauation interview. Arch Neurobol, 1997; 60: 171-84.

Responsible Party: Javier Garcia Campayo, Principal investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT03426709     History of Changes
Other Study ID Numbers: PI16/00962
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
Depression
Multimorbidity
Computer-delivered psychotherapy
Randomized-controlled trial
Cost-effectiveness

Additional relevant MeSH terms:
Depression
Back Pain
Low Back Pain
Chronic Disease
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes