DepressionNCT03426709
Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.
A study testing Low intensity Internet-delivered psychotherapy in people with Depression and Chronic Disease (Diabetes/Low Back Pain), run by Javier Garcia Campayo at 4 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Chronic Disease (Diabetes/Low Back Pain)
- What is being tested?
- Low intensity Internet-delivered psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 4 sitesSpain
- Study dates
- 26 Nov 2018to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Psychiatric Service. University Hospital Carlos Haya
Málaga, 29010
Health Science Research Institute, University Balearic Islands
Palma de Mallorca, Mallorca
Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
Valencia
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, 50009
About this study
Official title: 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.
Read the 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.
- Being tested
- Low intensity Internet-delivered psychotherapy
- Keywords
- Depression, Multimorbidity, Computer-delivered psychotherapy, Randomized-controlled trial, Cost-effectiveness
- Medical subject headings
- Depression, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity Internet-delivered psychotherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
In the TAU control group
Measured: Baseline
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Measured: Post-treatment 8-12 weeks from baseline in the intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Measured: Post-treatment 8-12 weeks from baseline in the TAU control group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Measured: 3 months follow up in the intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months follow up in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
In the Intervention group
Measured: Baseline
Diabetes control measured by VR d= Hb glucosidal
In the TAU control group
Measured: Baseline
Diabetes control measured by VR d= Hb glucosidal
Measured: Post-treatment 8-12 weeks from baseline in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Measured: Post-treatment 8-12 weeks from baseline in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
Measured: 3 months follow up in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Measured: 3 months follow up in the TAU control group
Secondary outcomes (20)
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the Intervention group and the TAU control group
Measured: 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.
Measured: Baseline
Health Survey 12 (SF-12)
In the Intervention group
Measured: Baseline
Health Survey 12 (SF-12)
In the TAU control group
Measured: Baseline
Health Survey 12 (SF-12)
Measured: Post-treatment 12 weeks from baseline in the intervention group
Health Survey 12 (SF-12)
Measured: Post-treatment 12 weeks from baseline in the TAU control group
Health Survey 12 (SF-12)
Measured: 3 months follow up in the intervention group
Health Survey 12 (SF-12)
Measured: 3 months follow up in the TAU control group
Client Service Receipt Inventory (CSRI)
In the Intervention group
Measured: Baseline
Client Service Receipt Inventory (CSRI)
In the TAU control group
Measured: Baseline
Client Service Receipt Inventory (CSRI)
Measured: Post-treatment 12 weeks from baseline in the intervention group
Client Service Receipt Inventory (CSRI)
Measured: Post-treatment 12 weeks from baseline in the TAU control group
Client Service Receipt Inventory (CSRI)
Measured: 3 months follow up in the intervention group
Client Service Receipt Inventory (CSRI)
Measured: 3 months follow up 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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").
Measured: 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).
Measured: Post module 1 (Psychoeducation) after an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start26 Nov 2018
- Primary completion20 Mar 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Garcia Campayo
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor-investigator, Javier Garcia Campayo, Hospital Miguel Servet
- Investigators
- Javier García-Campayo, Principal investigator, Miguel Servet Hospital and University os Zaragoza, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426709
- Sponsor's protocol ID
- PI16/00962
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18626028Katon 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.
PubMed 21190455Andersson 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.
PubMed 20183695Kaltenthaler 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.
PubMed 18757972Kroenke 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.
PubMed 11556941Diez-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.
PubMed 11485122Ostelo 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.
PubMed 15066687Stratford 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.
PubMed 8606899Kovacs 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.
PubMed 11880841Gandek 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.
PubMed 9817135Alonso 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.
PubMed 7783470Ferrando 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, 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.
PubMed 39928931
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03426709
- Acronym / sponsor ID
- PI16/00962
- Keywords
- Depression, Multimorbidity, Computer-delivered psychotherapy, Randomized-controlled trial, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Javier Garcia CampayoUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity Internet-delivered psychotherapy | Experimental | Behavioral: Low intensity Internet-delivered psychotherapyimproved 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity Internet-delivered psychotherapyThe 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 | Behavioural | Low intensity Internet-delivered psychotherapy |
Primary outcome
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.
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.
Patient Health Questionnaire (PHQ-9)
Time frame: 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)
Time frame: 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.
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.
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.
Patient Health Questionnaire (PHQ-9)
Time frame: 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.
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: Baseline
In the Intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: Baseline
In the TAU control group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: Post-treatment 8-12 weeks from baseline in the intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: 3 months follow up in the intervention group
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
Time frame: 3 months follow up in the TAU control group
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).
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).
Roland Morris Disability Questionnaire (RMDQ)
Time frame: 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)
Time frame: 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)
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).
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).
Diabetes control measured by VR d= Hb glucosidal
Time frame: Baseline
In the Intervention group
Diabetes control measured by VR d= Hb glucosidal
Time frame: Baseline
In the TAU control group
Diabetes control measured by VR d= Hb glucosidal
Time frame: Post-treatment 8-12 weeks from baseline in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
Time frame: 3 months follow up in the intervention group
Diabetes control measured by VR d= Hb glucosidal
Time frame: 3 months follow up in the TAU control group
20 secondary outcomes
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time frame: Baseline
The Mini-International Neuropsychiatric Interview (MINI)
Time frame: Baseline
Health Survey 12 (SF-12)
Time frame: Baseline
Health Survey 12 (SF-12)
Time frame: Baseline
Health Survey 12 (SF-12)
Time frame: Post-treatment 12 weeks from baseline in the intervention group
Health Survey 12 (SF-12)
Time frame: Post-treatment 12 weeks from baseline in the TAU control group
Health Survey 12 (SF-12)
Time frame: 3 months follow up in the intervention group
Health Survey 12 (SF-12)
Time frame: 3 months follow up in the TAU control group
Client Service Receipt Inventory (CSRI)
Time frame: Baseline
Client Service Receipt Inventory (CSRI)
Time frame: Baseline
Client Service Receipt Inventory (CSRI)
Time frame: Post-treatment 12 weeks from baseline in the intervention group
Client Service Receipt Inventory (CSRI)
Time frame: Post-treatment 12 weeks from baseline in the TAU control group
Client Service Receipt Inventory (CSRI)
Time frame: 3 months follow up in the intervention group
Client Service Receipt Inventory (CSRI)
Time frame: 3 months follow up in the TAU control group
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline in the intervention group and TAU control group
Positive and Negative Affect Schedule (PANAS)
Time frame: 3 months follow up in the intervention group and TAU control group
Positive and Negative Affect Schedule (PANAS)
Time frame: 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)
Time frame: Post-treatment 12 weeks from baseline in the intervention and TAU control group
Usefulness
Time frame: 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)
Time frame: Post module 1 (Psychoeducation) after an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Background: PubMed 18626028Bogner 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.
- Background: PubMed 21190455Katon 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.
- Background: PubMed 20183695Andersson 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.
- Background: PubMed 18757972Kaltenthaler 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 11485122Diez-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.
- Background: PubMed 15066687Ostelo 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.
- Background: PubMed 8606899Stratford 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.
- Background: PubMed 11880841Kovacs 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.
- Background: PubMed 9817135Gandek 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.
- Background: PubMed 7783470Alonso 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.
- BackgroundFerrando L, Bobes J, Gilbert J, Soto M, Soto O. MINI: MINI International Neuropsychiatric Interview, Madrid, IAP, 1998.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier García-Campayo principal investigator
Miguel Servet Hospital and University os Zaragoza, Spain
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity Internet-delivered psychotherapy in people with Depression and Chronic Disease (Diabetes/Low Back Pain), run by Javier Garcia Campayo at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426709, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.