Depressive Disorder Multiple Sclerosis (MS)
Conditions
Interventions
The online cognitive-behavioural self-help treatment examined in this study is
based on what is known as *problem-solving therapy* (PST). The original
PST-based intervention for depression is extens
for each of these problems the respondent makes a plan
how to cope with this). The six-step problem-solving method is the most
important step of the intervention containing the following steps: (1)
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: MS patients (minimum age 18) can take part if they: 1) are diganosed with MS 3 months befor the screening and 2) are able to manage the Dutch language. Inclusion criteria for the intervention are: 1) a minimum score of 20 on the Beck Depression Inventory (BDI-II), and the intention and capability to invest 5 weeks of their time to follow a selfhelp intervention through the internet.
Exclusion criteria
Exclusion criteria: No access to Internet or no email-address, no experience with Internet, no sufficient command of Dutch, unable to read, current use of antidepressants or other treatment of depression, current suicidal ideation. Subjects with contra-indications for MRI scanning or from Belgium will be excluded for the MRI study (see Onderzoeksprotocol, appendix 6, checklist MRI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect measurements will be taken at 0 weeks (first measurement) and upon conclusion of the treatment at five weeks, 4 months, 10 moths follow-up (post-tests). All measurement scales have shown to be reliable, valid and responsive, and have been widely used as an outcome measure in MS research and/or research on psychiatric conditions. Participants who score above the cut-off score of 20 on the BDI are invited for a structured clinical interview for depression and anxiety disorders (the World Health Organization's Composite International Diagnostic Interview; WHO CIDI, 1990). The CIDI interview is conducted by telephone, as well as the Percieved Need of Care Questionnaire (PNCQ) and the Expanded Disability Status Scale (EDSS). The PNCQ assesses the participants' perceptions of their needs for mental health care and the meeting of those needs. Interview (post-test, only for respondents participating in the MRI-study): Depression section of the structured clinical interview for presence of depression disorder and suicidal ideation (World Health Organiszation (WHO) version 2.1). The CIDI establishes diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (28). The CIDI interview is conducted by telephone Primary outcome measure is the Beck Depression Inventory (BDI-II). The BDI is a self-report instrument for assessing the existence and severity of depressive symptoms (Beck et al. 1961). Each of the 21 items match a symptom of depression according to the DSM-IV (DSM-IV, 1994). The total score is calculated by adding all the items and lies in between 0 and 63. The sum of the scores indicates the severity of the depression. Scores of 0 to 13 represent minimal depressive symptoms, scores from 14 to 19 indicate mild depression, scores from 20 to 28 moderate depression and scores of 29 to 63 indicate severe depression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include other measures of depression, problem solving skills, quality of life, well-being, disability level, social support, mastery, cognitive functioning, fatigue, anxiety and satisfaction. For comparison with the data of the Netherlands Study of Depression and Anxiety (NESDA) we decided to use another instrument to assess depressive symptoms. The Inventory of Depressive Symptomatology (IDS) consists of 28 questions, to assess the severity of depressive symptoms (Rush et al. 1996). The IDS assess all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) (APA 1994) to diagnose a major depressive episode. The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of an individual's anxiety (Beck et al. 1988). We also use the HADS (Zigmond & Snaith, 1983) to measure anxiety and depressive symptoms. The EuroQol (Dolan, 1997) consists of the EQ-5D and EQ-VAS. The EQ-5D describes quality of life on 5 dimensions: mobility, self care, daily activities (work, study, etc.), pain or other symptoms and anxiety / depression. Each dimension consists of 3 possible answer categories: no problems, some problems, serious problems. The EQ-VAS is a scale from 0 to 100 on which the patient indicates how well they perceive their current health situation, where 0 is the worst possible health state and 100 the best imaginable health state. The MSIS-29 (Hobert et al, 2001) is used to measure the impact of MS en de WHO-5 (Bech, 2004) for measuring well-being. The Fatigue Severity Scale (FSS) (Krupp et al. 1989) is a 9-item scale, used to assess the severity of fatigue. The Multiple Sclerosis neuropsychological questionnaire (MSNQ) is a self-report screening that is used to measure of neuropsychological functioning in MS (Benedict et al. 2003). Three subscales of the Social Pr | — |
Countries
Netherlands
Outcome results
None listed