An interventional study of Low intensity Internet-delivered psychotherapy in Depression and Chronic Disease (Diabetes/Low Back Pain), sponsored by Javier Garcia Campayo. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Javier Garcia Campayo · Not applicable, Interventional, and Treatment
Among 225 studies in Depression with a site in Spain — 46 open to participants now, 58 under way, 7 of them phase 3. Depression · Spain.
Among the 225 studies in Depression with a site in Spain, this one is the 60th largest by enrollment of the 189 interventional ones that give a count, is one of 10 that started in 2018, is one of 153 with no phase, and was the 71st registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →46 of the 225 studies in Depression with a site in Spain are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Spain, United States, Australia and 12 more countries
Ages 18–75
University of Seville · Sites in Spain
Ages 18+ · Women only · Healthy volunteers
University of Seville · Sites in Spain
Ages 18+ · Healthy volunteers
Fundació Sant Joan de Déu · Sites in Spain
Ages 18+
University of the Basque Country (UPV/EHU) · Sites in Spain
Ages 18–65
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
225 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 14 · Phase 3 18 · Phase 4 6
First in 2002; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 196 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Median enrollment 123 across the 189 interventional studies, 303 across the 36 observational. Of the 130 that completed or were terminated, 17 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 225 have an industry lead sponsor. The 10 most frequent:
Javier Garcia Campayo is the lead sponsor of 4 studies on the registry; none are open to participants now.
Javier Garcia Campayo has 2 studies filed under Depression — fewer than ten, so there is no comparison to draw.
9 of the studies in Depression with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
| NCT07925723Universidad Miguel Hernandez de ElcheALAS PROPIAS: Music Therapy for Women Experiencing Machista Violence in Intimate Partner Relationships | 2026-11-30 |
| NCT07292610University of Castilla-La ManchaImpact of Nut Consumption on Mental Health in Young Adults | 2026-12 |
| NCT05289258Universidad de CórdobaUnified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments | 2026-12-30 |
| NCT04084795Parc de Salut MarAugmentation of EMDR With tDCS in the Treatment of Fibromyalgia | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 225 studies in Depression with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline
Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)
In the TAU control group
Time frame: Baseline
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)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 3 months follow up in the TAU control group
Diabetes control measured by VR d= Hb glucosidal
In the Intervention group
Time frame: Baseline
Diabetes control measured by VR d= Hb glucosidal
In the TAU control group
Time frame: Baseline
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
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the Intervention group and the TAU control group
Time frame: 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.
Time frame: Baseline
Health Survey 12 (SF-12)
In the Intervention group
Time frame: Baseline
Health Survey 12 (SF-12)
In the TAU control group
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)
In the Intervention group
Time frame: Baseline
Client Service Receipt Inventory (CSRI)
In the TAU control group
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)
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).
Time frame: 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).
Time frame: 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).
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)
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).
Time frame: 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").
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)
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).
Time frame: Post module 1 (Psychoeducation) after an average of 1 week
Ran from Nov 2018 to primary completion in Mar 2020, 15 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 15 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Javier Garcia Campayo