Major Depressive Disorder Clinical Trial
— E-COMPARED_SOfficial title:
European Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial
NCT number | NCT02361684 |
Other study ID # | UJaumeI07 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | September 2019 |
Verified date | September 2019 |
Source | Universitat Jaume I |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.
Status | Completed |
Enrollment | 160 |
Est. completion date | September 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Being 18 years of age or older - Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0 - a score a score of 5 or higher on the PHQ-9 screening questionnaire. Exclusion Criteria: - Current high risk for suicide according to the MINI Interview section C - Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview - Currently receiving psychological treatment for depression in primary or specialised mental health care - Being unable to comprehend the spoken and written language (Spanish) - Not having access to a PC and fast Internet connection (i.e. broadband or comparable). - Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment |
Country | Name | City | State |
---|---|---|---|
Spain | University Jaume I | Castelló de la Plana | Castellón |
Spain | University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I | University of Valencia |
Spain,
Bangor A, Kortum PT, Miller JT. (2008). An Empirical Evaluation of the System Usability Scale. Int J Hum Comput Interact 2008, 24:574-594.
Black WC. The CE plane: a graphic representation of cost-effectiveness. Med Decis Making. 1990 Jul-Sep;10(3):212-4. — View Citation
Brooke J. (1996). SUS-a quick and dirty usability scale. In Usability Eval Ind. Volume 189. Edited by Jordan PW, Thomas B, Weerdmeester BA, McClelland IL. London: Taylor & Francis Ltd; 1996:189-194.
Corruble E, Legrand JM, Zvenigorowski H, Duret C, Guelfi JD. Concordance between self-report and clinician's assessment of depression. J Psychiatr Res. 1999 Sep-Oct;33(5):457-65. — View Citation
Cuijpers P, Turner EH, Koole SL, van Dijke A, Smit F. What is the threshold for a clinically relevant effect? The case of major depressive disorders. Depress Anxiety. 2014 May;31(5):374-8. doi: 10.1002/da.22249. Epub 2014 Feb 22. — View Citation
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation
Fenwick E, O'Brien BJ, Briggs A. Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. Health Econ. 2004 May;13(5):405-15. — View Citation
Food Drug Administration (FDA) (1997). International conference on harmonization, good clinical practice: consolidated guidelines. Federal Register 62: 25692-25709.
Hakkaart-van Rooijen L, van Straten A, Donker M, Tiemans B. (2002). Manual Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Rotterdam: Institute for Medical Technology Assessment.
Hatcher RL, Gillaspy JA. (2007). Development and validation of a revised short version of the working alliance inventory. Psychother Res, 16:12-25.
Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999 May;8(3):209-24. — View Citation
König HH, Born A, Günther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C. Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes. 2010 May 5;8:47. doi: 10.1186/1477-7525-8-47. — View Citation
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. — View Citation
Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Dunbar GC. (1997). The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. European Psychiatry, 12(5), 224-231.
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. — View Citation
Pinninti NR, Madison H, Musser E, Rissmiller D. MINI International Neuropsychiatric Schedule: clinical utility and patient acceptance. Eur Psychiatry. 2003 Nov;18(7):361-4. — View Citation
Richardson JR, Peacock SJ, Hawthorne G, Iezzi A, Elsworth G, Day NA. Construction of the descriptive system for the Assessment of Quality of Life AQoL-6D utility instrument. Health Qual Life Outcomes. 2012 Apr 17;10:38. doi: 10.1186/1477-7525-10-38. — View Citation
Rush AJ, Carmody T, Reimitz PE. (2000). The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and Self-Report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9(2), 45-59.
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585. — View Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. Review. — View Citation
van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ. Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Soc Sci Med. 1994 Dec;39(11):1537-44. — View Citation
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Patient Health Questionnaire-9 | The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. The 9 items are each scored on a 0-3 scale with the total score ranging from 0-27 and higher scores indicating more severe depression. The PHQ-9 has shown to have good psychometric properties (Wittkampf, Naeije, Schene, Huyser, & van Weert, 2007). | Baseline, 3 months, 6 months and 12 months | |
Secondary | Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation | The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity. The QIDS is available in both clinician-rated (IDS-C) and patient self-report (IDS-SR) forms. The QIDS consists of 16 items (each item scores 0-3) and includes symptom domains of MDD based on DSM-IV and Research Diagnostic Criteria (RDC). The QIDS has shown good psychometric properties. | Baseline, 3 months, 6 months and 12 months | |
Secondary | Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0 | The M.I.N.I. is a structured diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and on International Classification of Diseases (ICD-10) criteria. The M.I.N.I has been translated to 65 languages and is used for both clinical and research practice. The interview compares well with Structural Clinical Interview for DSM-IV disorders (SCID) (Sheehan et al., 1998) and the Composite International Diagnostic Interview (CIDI) (Lecrubier et al., 1997; Sheehan et al., 1998). | Baseline and 12 months | |
Secondary | Change in the EQ-5D-5L (EuroQol) | The EQ-5D-5L is a self-report questionnaire which measures health related quality of life and enables conversion to utility scores to calculate Quality-Adjusted Life-Years (QALYs). The EQ-5D-5L consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. Each item consists of five categories ranging from no problems to a lot of problems (Van Agt, Essink-Bot, Krabbe, & Bonsel, 1994). | Baseline, 3 months, 6 months and 12 months | |
Secondary | Change in the Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002) | The TiC-P is a self-report questionnaire and consists of two different parts that can be administrated separately. Part I will be used to assess the participants' healthcare utilization and medication use. Part II (short form health and labor questionnaire [SF-HLQ]) measures lost productivity costs resulting from absenteeism (being absent from work because of illness) and presenteeism (being present at work while ill which may lead to reduced efficiency) and consists of 11 items. Healthcare utilization and productivity losses will be valued using country-specific prices. | Baseline, 3 months, 6 months and 12 months | |
Secondary | Change in the Working Alliance Inventory (WAI-SF) | The WAI-SF is a 12-item self-report questionnaire with responses on a 5-point Likert scale ranging from 1 (never) to 5 (always) (Hatcher & Gillaspy, 2006). The questionnaire covers three dimensions of working alliance: (1) therapeutic goals, (2) tasks, and (3) bond and the subscales have shown to have good internal consistencies. Both the patient and the 10-item therapist version of the questionnaire will be administered | 3 months | |
Secondary | Change in the credibility and expectancy questionnaire (CEQ; Devilly and Borkovec, 2000) | The scale consists of 6 questions, with answer options rated on a 10 point scale and on a 1-100% scale and evaluates 2 factors : credibility and expectancy | Baseline | |
Secondary | Change in the Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983) | This questionnaire is used to measure global patient satisfaction. The questionnaire consists of 8 items that are measured on a 4 points scale with total scores ranging from 8 to 32 and has shown good psychometric properties. | 3 months | |
Secondary | Change in the system usability scale (SUS; Brooke, 1996) | SUS is a simple ten item scale giving a global view of subjective assessments of usability of a technology system. All items are measured on a 5-point scale ranging from strongly disagree until strongly agree. Total SUS scores have a range from 0-100. | 3 months |
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