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van CCT (UK)

van CCT (UK)

Gedragsactivatie door de POH-GGZ versus gebruikelijke behandeling voor depressie bij oudere volwassenen in de eerste lijn.

- candidate number25205
- NTR NumberNTR6013
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2016
- Secondary IDsNL54470.091.16 
- Public TitleGedragsactivatie door de POH-GGZ versus gebruikelijke behandeling voor depressie bij oudere volwassenen in de eerste lijn.
- Scientific TitleBehavioural activation delivered by mental health nurses versus treatment as usual for late-life depression in primary care.
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedDepression, Older adults
- Inclusion criteriaThe main inclusion criterion is a PHQ-9 score >9.
- Exclusion criteriaPatients 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2016
- planned closingdate9-feb-2018
- Target number of participants200
- InterventionsIn 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.
- Primary outcomeDepression severity as assessed with the Quick Inventory of Depressive Symptomatology (Q-IDS) during the 8-week treatment period and follow-up.
- Secondary outcomeWhen 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.
- TimepointsParticipants 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.
- Trial web
- status[default]
- Sponsor/Initiator Pro Persona, Radboud University Medical Center Nijmegen, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsHendriks, G. J., Oude Voshaar, R. C., Keijsers, G. P., Hoogduin, C. A. and van Balkom, A. J. (2008). Cognitive-behavioural therapy for late-life anxiety disorders: a systematic review and meta-analysis. Acta Psychiatr Scand, 117, 403-411.

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.

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.

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.
- Brief summaryWith 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).
- Main changes (audit trail)
- RECORD25-aug-2016 - 7-okt-2016

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