The goal of this research project is to evaluate feasibility and outcome of a cognitive behavioural therapy self-help intervention offered through the Internet in multiple sclerosis (MS) patients with a comorbid depressive disorder.
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect measurements will be taken at 0 weeks (first measurement) and upon
conclusion of the treatment at five weeks (last measurement). The primary
outcome measure is the BDI, which will be used to measure the reduction in the
severity of the depression.
We will register the willingness of the MS-patients to participate in the
web-based treatment. In addition, we will analyse the specific composition of
the group of patients who are willing to participate. During the intervention
we will keep track of work-progress, work-pace and activity of the patients.
These data will be summarized to analyze the compliance of patients with the
intervention. After the intervention (5 weeks) patient satisfaction with the
care received will be assessed by means of the Client Satisfaction
Questionnaire (CSQ-8) (De Brey 1983). We will also ask the participating
subjects to complete a brief survey in which they are asked to share their
experiences, opinions and any suggestions for enhancing the intervention.
Secondary outcome
A number of secondary outcome measures will also be employed, including the
EuroQol, which measures the degree of impairment and the quality of life (Dolan
1999) and the Medical Outcome Study Short Form 26 (SF-36), which measures
health status (Freeman et al. 2000). Symptoms of anxiety will be assesed using
the Hospital Anxiety and Depression scales (HADS).
Background summary
There is a high incidence of comorbid depressive disorders among people with
MS. Despite high prevalence figures, cases of depression fail to be diagnosed
in more than half of all MS patients, and adequate treatment tends to be
lacking. Effectiveness studies have shown that MS patients are receptive to
treatment for their depressive episodes. It has been demonstrated that
self-help cognitive behavioural therapy * the *problem-solving treatment* *
using the Internet as a medium is an effective intervention for reducing
depressive complaints. In this study, the self-help intervention will be
offered through the Internet (Dutch website: allesondercontrole.psy.vu.nl).
This accessible self-help intervention has never previously been investigated
for treatment of MS patients with comorbid depressive symptoms.
Study objective
The goal of this research project is to evaluate feasibility and outcome of a
cognitive behavioural therapy self-help intervention offered through the
Internet in multiple sclerosis (MS) patients with a comorbid depressive
disorder.
Study design
The feasibility and effectiveness of a low-intensity Internet-based self-help
treatment for MS patients will be evaluated in a non-randomized study.
Intervention
In view of the findings described above, the obvious next step is to use the
Internet as a medium in providing an accessible treatment that has proven
effective in patients with depressive disorders. We aim for such treatment to
link up with an existing intervention that is currently being offered as part
of various depression trials. The intervention at issue is called
Allesondercontrole (*everything-under-control*; website:
allesondercontrole.psy.vu.nl). This intervention takes up little time and is
based on what is known as *problem-solving treatment*, comprising a cognitive
behavioural therapy self-help intervention. The existing Allesondercontrole
intervention has a duration of five weeks. During this period, participants are
asked to identify the things that are most important to them in their lives;
their answers are then used to create an inventory of problems currently
affecting them in their lives. These problems are subsequently placed into one
of three different categories: unimportant problems (problems that are
unrelated to the things that are important in life); important and resolvable
problems (these problems are resolved using the six-step problem-solving
method) and important but irresolvable problems (for example, a lost loved-one;
these problems are addressed by means of a specially designed plan for learning
to cope with the loss). Dutch and international studies alike have found the
intervention to be effective in the treatment of depression. A recent
meta-analysis has shown that Internet-based self-help interventions are just as
effective in treating depressive disorders as are face-to-face treatments.
Study burden and risks
The burden of participation will be 2 hours of extra work, next to the
intervention. These 2 hours consist of:
- screening questionnaire (5-10 minutes)
- interview by telephone (45 minutes)
- pre-test: several questionnaires (30 minutes)
- post-test: several questionnaires (35 minuten)
Participation in this study is without any risks.
A.J. Ernststraat 887
1081 HL Amsterdam
Nederland
A.J. Ernststraat 887
1081 HL Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients (minimum age 18) from the MS centre of the VU medical centre can take part if they: 1) are diagnosed 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 16 on the Beck Depression Inventory (BDI) and the intention and capability to invest 5 weeks of their time to follow a selfhelp intervention through the internet.
Exclusion criteria
No access to Internet or no email-address, no experience with Internet, unable to read, current use of antidepressants or other treatment of depression, current suicidal ideation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25173.029.08 |