The aims are threefold: i) to assess the efficacy of a cognitive behavioural group (CBT) intervention in reducing relapse rates in remitted anxiety disorder patients who discontinue AD, as compared with AD discontinuation alone; ii) to investigate…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is relapse within a year.
Secondary outcome
Secondary outcome measures are i) time to relapse; ii) one-year course of
anxiety symptoms; iii) quality of life; iv) patient satisfaction; v)predictors
of relapse; vi) cost-effectivity; and vii) cost-utility.
Background summary
To improve the long-term course of anxiety disorders, relapse prevention should
be an integrated part of treatment. As discontinuing antidepressants (AD) is
associated with high relapse rates, relapse prevention is even more important
in patients who discontinue AD. This study is proposed because cost-effective
evidence-based strategies aimed to prevent relapse after discontinuing AD are
lacking.
Study objective
The aims are threefold: i) to assess the efficacy of a cognitive behavioural
group (CBT) intervention in reducing relapse rates in remitted anxiety disorder
patients who discontinue AD, as compared with AD discontinuation alone; ii) to
investigate predictors for relapse to enable further specification of those at
highest risk; iii) to calculate cost-effectivity and cost-utility of the
intervention.
Study design
The efficacy will be studied in a multicenter randomized controlled trial with
220 patients with anxiety disorders in remission. After the intervention,
relapse will be followed monthly for one year. Predictors of relapse are
assessed at baseline and after the intervention, at 4 months after baseline.
For economic analysis, three monthly assessments will take place. A pilot study
to test the protocol is being conducted.
Sample size calculation
110 Patients will be included in each condition, based on an estimated effect
size of 0.50, a power of 0.80 and a 2-sided p-value of 0.05.
Economic evaluation
Analyses are undertaken from a societal perspective. Both direct and indirect
costs are calculated. A cost-efficacy analysis assesses the costs per relapse
prevented. A cost-utility analysis assesses the costs/QALY gained.
Time schedule
Eight months inclusion, four months intervention, one year follow-up.
Intervention
The intervention consists of AD discontinuation and CBT in a group format.
Based on prior research, efficacy is assumed. The control intervention consists
of AD discontinuation alone.
Study burden and risks
We presume that there are no risks. The burden consists of time spend for the
psychological screening involving questionnaires and interviews.
A.J. Ernststraat 887
1081 HT Amsterdam
NL
A.J. Ernststraat 887
1081 HT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Included are adults aged 18-65 years i) who use AD for panic disorder (with or without agoraphobia), social phobia or generalized anxiety disorder; ii) who are in remission; and iii) who want to discontinue AD.
Exclusion criteria
Patients with a comorbid dementia, psychotic disorder, alcohol or drug dependence or who do not speak Dutch are excluded.
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 | NL30576.029.09 |