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

NCT03426709 | Completed

• 1 other identifier: PI16/00962
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression; Chronic Disease (Diabetes/Low Back Pain)

Keywords

Depression; Multimorbidity; Computer-delivered psychotherapy; Randomized-controlled trial; Cost-effectiveness

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (20)

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline

• The Mini-International Neuropsychiatric Interview (MINI)

  Baseline

• Health Survey 12 (SF-12)

  Baseline

• Health Survey 12 (SF-12)

  Baseline

• Health Survey 12 (SF-12)

  Post-treatment 12 weeks from baseline in the intervention group

Study Arms (2)

Low intensity Internet-delivered psychotherapy

EXPERIMENTAL

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

Improved Treatment-as-usual (TAU)

NO INTERVENTION

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.

Interventions

Low intensity Internet-delivered psychotherapy BEHAVIORAL

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

Low intensity Internet-delivered psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javier Garcia Campayo: lead
• Carlos III Health Institute: collaborator

Study Sites (4)

Health Science Research Institute, University Balearic Islands

Palma de Mallorca, Mallorca, Spain

Location

Psychiatric Service. University Hospital Carlos Haya

Málaga, 29010, Spain

Location

Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute

Valencia, Spain

Location

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (17)

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  PMID: 18626028 BACKGROUND

• Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.

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• Ferrando L, Bobes J, Gilbert J, Soto M, Soto O. MINI: MINI International Neuropsychiatric Interview, Madrid, IAP, 1998.

  BACKGROUND

• Beecham JK, et al. Costing psychiatric interventions. In: Thornicroft G, ed. Measuring mental health needs. London: Royal College of Psychiatrists; 2001; 200-224.

  BACKGROUND

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  BACKGROUND

• Monreal-Bartolome A, Castro A, Perez-Ara MA, Gili M, Mayoral F, Hurtado MM, Varela Moreno E, Botella C, Garcia-Palacios A, Banos RM, Lopez-Del-Hoyo Y, Garcia-Campayo J, Montero-Marin J. Efficacy of a Blended Low-Intensity Internet-Delivered Psychological Program in Patients With Multimorbidity in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2025 Feb 10;27:e56203. doi: 10.2196/56203.

  PMID: 39928931 DERIVED

• Varela-Moreno E, Anarte-Ortiz MT, Jodar-Sanchez F, Garcia-Palacios A, Monreal-Bartolome A, Gili M, Garcia-Campayo J, Mayoral-Cleries F. Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 May 16;12:e55483. doi: 10.2196/55483.

  PMID: 38754101 DERIVED

• Monreal-Bartolome A, Barcelo-Soler A, Castro A, Perez-Ara MA, Gili M, Mayoral F, Hurtado MM, Moreno EV, Botella C, Garcia-Palacios A, Banos RM, Lopez-Del-Hoyo Y, Garcia-Campayo J. Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial. BMC Psychiatry. 2019 Feb 11;19(1):66. doi: 10.1186/s12888-019-2037-3.

  PMID: 30744610 DERIVED

Related Links

• Official website of the Spanish Research Network in Primary Care (Rediapp)

MeSH Terms

Conditions

Depression; Chronic Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier García-Campayo

  Miguel Servet Hospital and University os Zaragoza, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: November 26, 2018
• Primary Completion: March 20, 2020
• Study Completion: December 21, 2020
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

ES (4)