The primary objective of this trial is to determine the clinical and cost effectiveness of computerized cognitive behavioural therapy with therapist support, compared to face-to face therapy based on cognitive-behavioural techniques for mild to…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the presence/ severity of depressive symptoms as
measured with the Beck Depression Inventory. Measurement takes place over time
at (1) baseline, (2) post-treatment, (3) six-month follow-up and (4)
twelve-month follow-up.
Other clinical and economic questionnaires will be used to back up the main
study parameter (see Table 7 1 in protocol) . More specifically, they will be
used to answer the research questions about (cost) effectiveness.
Secondary outcome
The secondary study parameters are: (1) client acceptability ratings, as
measured with the (composed) questionnaire AFQ; (2) presence/ severity of
anxiety symptoms, as measured with the anxiety subscale of the CORE-34 and with
the GAD-7.
Age, sex, social economic status and ethnical background will be used as
prognostic factors (3).
Background summary
Our general aim is to evaluate the Dutch version of Beating the Blues, a
computer-based cognitive behavioural therapy for mild to moderate depressive
complaints, offered in conjunction with limited therapist support. The
effectiveness of Beating the Blues has been established in the UK, but not yet
in the Netherlands. However, the program is currently used in Dutch practices
of Mentaal Beter, as an alternative to face-to-face therapy based on
cognitive-behavioural techniques. On the basis of the available literature, we
hypothesize that computerized cognitive-behavioural therapy with limited
therapist support is not inferior to face-to-face therapy based on
cognitive-behavioural techniques.
Study objective
The primary objective of this trial is to determine the clinical and cost
effectiveness of computerized cognitive behavioural therapy with therapist
support, compared to face-to face therapy based on cognitive-behavioural
techniques for mild to moderate depressive symptoms. Secondary objectives
include the acceptability of the two forms of treatment, as well as their
influence on symptoms of anxiety. Additionally, predictors and moderators of
outcome will be investigated.
Study design
A non-inferiority randomized clinical trial will be conducted, with 374
participants randomly allocated to either computerized cognitive-behavioural
therapy with limited therapist support or face-to-face therapy based on
cognitive-behavioural techniques. We will make use of blocked randomization to
assure an equal amount of participants in each group. Blinding is not possible
- both the researcher and the participant are aware of the allocated condition,
but only so after the screening and randomization. The study will be preceded
by an external pilot, with 30 participants.
Intervention
Beating the Blues consists of eight fifty-minute (inter)active modules with a
cognitive-behavioural content, elucidated by several returning case studies.
Each session ends with a summary and with home-work assignments. The Dutch
version of Beating the Blues is offered with limited therapist support (three
face-to-face contacts).
Study burden and risks
It is unlikely that Beating the Blues or the treatment as usual will lead to
serious adverse events. As such, the study poses no risk to the participants.
However, the participants are asked to invest time into this study. The
screening will be conducted by telephone and will take approximately 30-40
minutes. Furthermore, over a one-year period, four sets of questionnaires will
be offered via the internet. It will approximately take 30-50 minutes to
complete each set of questionnaires.
Asterweg 19D12; unit 12
1031 HL, Amsterdam
NL
Asterweg 19D12; unit 12
1031 HL, Amsterdam
NL
Listed location countries
Age
Inclusion criteria
BDI-II-NL range 14 to 28;Duration complaints >= two months;Age range 18 to 65 ;Native Dutch speaker;Access to internet and e-mail at home
Exclusion criteria
Other psychological treatment for complaints;Presence of suicide ideation (currently) ;Severe co-morbid disorders ;Substance abuse (alcohol/ drugs)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33917.097.10 |
| OMON | NL-OMON22545 |