Depression sadness
Conditions
Interventions
Treatment in both groups is based on a CBT protocol for face-to-face treatment
of depression by Bockting and Huibers (2011). CBT is one of the most
recommended treatments for depression, according t
www.minddistrict.com). Patients access this
p
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of major depressive disorder Age>18 years Sufficient command of the Dutch Language Access to the Internet, an e-mail adress and a personal computer (PC) or tablet computer Willing to be randomised to one of the two treatment conditions Signed informed consent form
Exclusion criteria
Exclusion criteria: Bipolair, psychotic or substance abuse disorder and/or a acute rise of suicide (as signaled by the answer yes to questions 4 or 5 or 3+6 in section C of the MINI plus diagnostic interview)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The health-economic analyses combine clinical outcomes with cost estimates. Measures of these primary variables are described in this section. Clinical outcomes Primary clinical outcomes are 1) recovery from Depression as assessed by the Mini-International Neuropsychiatric Interview (MINI), 2) changes in Depressive symptom severity as measured by the Inventory of Depressive Symptomatology * Self Report (IDS-SR), 3) quality-adjusted life years (QALY*s), derived from the Euro Quality of Life questionnaire (EQ-5D-3L) and 4) health-related quality of life, tapped by the SF-36 Health Survey. The Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1992; Van Vliet et al., 2007) is a brief clinician-administered structured diagnostic interview for assessing the presence of DSM-IV and ICD-10 psychiatric disorders. The interview takes 45 minutes to conduct at the most, depending on the amount of disorders that are present. In this study, independent, trained research assistants, who are blind to the random allocation, will administer the MINI either over the telephone or face-to-face at the clinic (based on patient preference). At T0 and T3, the MINI will be administered in full. At T1 and T2, current state will be assessed through a focused telephone or face to face interview, in which only MINI section A & B are administered (assessing depressive disorders and dysthymic disorder). At T0, the lifetime-version is administered (which also yields current state). At T1-T3, the MINI is only focused on *current* symptoms of the participant. The IDS-SR (Rush et al., 1986; Rush et al., 1996; Rush et al., 2000) is a self-report measure of the severity of depressive symptoms in the past week. It consists of 28 items which each have four response categories, ranging from 0 (low severity) to 3 (high severity). The total score varies between 0 and 84, with higher scores being indicative of a higher severity of depressive symptoms. For this stud | — |
Secondary
| Measure | Time frame |
|---|---|
| To further evaluate bCBT compared to CBTAU, a number of explorative measures are administered. The Quick Inventory of Depressive Symptomatology (QIDS-SR; Rush et al., 2003), a shortened version of the IDS-SR, will be administered monthly during the study period to more closely monitor the depressive symptom change trajectory (at weeks 4, 8, 12, 16, 24, 28). This questionnaire consists of 16 questions. The total score ranges from 0 to 27, with higher scores being indicative of a higher severity of depressive symptoms. The five item version of The Mastery Scale (Pearlin, & Schooler, 1987) is administered at every assessment moment (T0-T3) to assess changes in locus of control. Locus of control could potentially mediate treatment effect and facilitate relapse prevention (Badamgarav et al., 2003; Neumeyer-Gromen et al., 2004) The questionnaire consists of five questions, which are scored on a five-point Likert-scale, ranging from 1 (totally disagree) to 5 (totally agree). The total score ranges from 5 to 30, with higher scores being indicative of a higher level of experienced control. The 12-item version of the Work Alliance Inventory (WAV-12, Reynolds et al., 1995; Andrusyna et al., 2001; Stinckens et al., 2009) is used to let patients rate the quality of the work alliance between patient and therapist at T1 (week 10). The questionnaire is administered to investigate whether the blended treatment for has an effect on the quality of the work alliance. The questionnaire consists of 12 items, which are scored on a five-point Likert-scale, ranging from 1 (seldom or never) to 5 (always). The raw scores range from 12 to 60, with higher scores being indicative of a better alliance between therapist and patient. The depression scale of the Cognition Checklist (Beck et al., 1987) will be used to assess the frequency of automatic thoughts relevant to depression, at T0-T3. The depression scale consists of 14 questions on which a patient rates the frequ | — |
Countries
Netherlands
Outcome results
None listed