No registrations found.
ID
Source
Brief title
Health condition
Late-life depression, depressive symptoms, depressie, depressieve symptomen, depressieve klachten, elderly.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression severity as assessed with the Quick Inventory of Depressive Symptomatology (Q-IDS) during the 8-week treatment period and follow-up.
Secondary outcome
When proven effective, our next interest is the cost-effectiveness of BA. The EuroQol (EQ-5D-5L) and TiC-P are used.
Furthermore, several moderators and process variables will be investigated.
Background summary
With 12-25% prevalence, clinically significant depression is common in later life. However, the efficacy of current pharmacological and psychological treatments is limited. Behavioural programmes for late-life depression have recently received renewed attention with findings suggesting that Behavioural Activation (BA) may be effective. The primary objective of this study is to compare the effectiveness and cost-effectiveness of behavioural activation (BA) and treatment as usual (TAU) for late-life depression in primary care in the Netherlands. A cluster-randomised and controlled multicentre trial (RCT) is conducted, with two parallel groups: a) Behavioural activation, and b) Treatment as usual, conducted in primary care centres (PCC) with a follow-up of 52 weeks (FU).
Study objective
The main hypothesis is that compared to TAU, BA will be more effective and less costly. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression.
Study design
Participants in both the BA- and TAU-condition will complete these measures every two to three weeks during the 8 week therapy period, at post-treatment, and every three months during the 52-week follow-up.
Intervention
In behavioural activation (BA) patients are encouraged to increase their activity levels, engage in more reinforcing and pleasurable activities, and modify avoidance and withdrawal patterns. BA is a component of cognitive-behavioural therapy (CBT), a more complex approach targeting both thoughts and behaviours.
PO Box 7049,
G.J. Hendriks
Nijmegen 6503 GM
The Netherlands
+31-24-3837820
ghendriks@ggznijmegen.nl
PO Box 7049,
G.J. Hendriks
Nijmegen 6503 GM
The Netherlands
+31-24-3837820
ghendriks@ggznijmegen.nl
Inclusion criteria
The main inclusion criterion is a PHQ-9 score >9.
Exclusion criteria
Patients will be excluded from the trial in the case of I) severe mental illness in need of specialized treatment, including severe major depression, bipolar disorder, obsessive-compulsive disorder, (history of) psychosis; II) high risk of suicide, III) drug and/or alcohol abuse or dependence, IV) prior psychotherapy received in the previous 12 weeks V) current treatment by a mental health specialist. VI) moderate to severe cognitive impairment (MoCA <18).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5436 |
| NTR-old | NTR6013 |
| CCMO | NL54470.091.16 |
| OMON | NL-OMON47861 |
Summary results
Huibers, M. J., et al. (2014). Predicting response to cognitive therapy and interpersonal therapy, with or without antidepressant medication, for major depression: a pragmatic trial in routine practice. J Affect Disord, 152-154, 146-154.
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Lemmens, L. H., Arntz, A., Peeters, F., Hollon, S. D., Roefs, A. and Huibers, M. J. (2015). Clinical effectiveness of cognitive therapy v. interpersonal psychotherapy for depression: results of a randomized controlled trial. Psychol Med, 1-16.<br><br>
Licht-Strunk, E., Van Marwijk, H. W., Hoekstra, T., Twisk, J. W., De Haan, M. and Beekman, A. T. (2009). Outcome of depression in later life in primary care: longitudinal cohort study with three years' follow-up. BMJ, 338, a3079.