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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Disease (Diabetes/Low Back Pain)
• Intervention / Treatment: Behavioral: Low intensity Internet-delivered psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Psychiatric Service. University Hospital Carlos Haya
  • Valencia, Spain
    • Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
  • Zaragoza, Spain, 50009
    • Department of Psychiatry. Miguel Servet University Hospital
  • Mallorca
    • Palma de Mallorca, Mallorca, Spain
      • Health Science Research Institute, University Balearic Islands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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)		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).	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		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
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.	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)		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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data Gender, age, marital status, education, occupation, economical level	In the Intervention group and the TAU control group	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.	Baseline
Health Survey 12 (SF-12)	In the Intervention group	Baseline
Health Survey 12 (SF-12)	In the TAU control group	Baseline
Health Survey 12 (SF-12)		3 months follow up in the intervention group
Health Survey 12 (SF-12)		3 months follow up in the TAU control group
Client Service Receipt Inventory (CSRI)	In the Intervention group	Baseline
Client Service Receipt Inventory (CSRI)	In the TAU control group	Baseline
Client Service Receipt Inventory (CSRI)		3 months follow up in the intervention group
Client Service Receipt Inventory (CSRI)		3 months follow up in the TAU control group
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
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)	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).	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).	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).	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).	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").	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).	Post module 1 (Psychoeducation) after an average of 1 week

Collaborators and Investigators

• Sponsor: Javier Garcia Campayo
• Collaborators: Carlos III Health Institute
• Investigators: Principal Investigator: Javier García-Campayo, Miguel Servet Hospital and University os Zaragoza, Spain

Publications and helpful links

General Publications

• Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
• Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.
• 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.
• Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.
• Bogner HR, de Vries HF. Integration of depression and hypertension treatment: a pilot, randomized controlled trial. Ann Fam Med. 2008 Jul-Aug;6(4):295-301. doi: 10.1370/afm.843.
• Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181-4. doi: 10.1192/bjp.bp.106.025981. Erratum In: Br J Psychiatry. 2008Oct;193(4):346.
• Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol. 2004 Mar;57(3):268-76. doi: 10.1016/j.jclinepi.2003.09.005.
• Stratford PW, Binkley J, Solomon P, Finch E, Gill C, Moreland J. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther. 1996 Apr;76(4):359-65; discussion 366-8. doi: 10.1093/ptj/76.4.359.
• Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Cost-effectiveness; Multimorbidity; Computer-delivered psychotherapy; Randomized-controlled trial
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Back Pain; Depression; Low Back Pain; Chronic Disease
• Other Study ID Numbers: PI16/00962

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No