The primary objective is to investigate whether (and if so, which) type of CBT-element (cognitive restructuring (CR), behavioral activation (BA), relaxation (RE) and problem solving skills(PS)) is relevant for the positive effect of CBT-programs on…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-reported depressive symptoms
Secondary outcome
Depressive symptoms according to the parent
Depression diagnosis
Top three problems
Suicide risk
Quality of life
Care costs
Other study parameters are:
Possible moderator variables: Depression severity, comorbidity and demographic
variables.
Possible mediator variables: Negative automatic thoughts, behavioral
activation, relaxation and problem solving skills.
Treatment characteristics: Expectancy of treatment, previous treatments,
therapeutic alliance, groups cohesion, cooperation with treatment, satisfaction
with treatment and treatment integrity.
Background summary
Depression during adolescence is a major public health concern, because of its
high prevalence, association with suicide, co-morbid psychiatric diagnoses and
high treatment costs. Even sub-clinical levels of depressive symptoms put
adolescents at risk for several negative outcomes. Therefore, it is important
that depression is detected at an early stage and is treated preventively.
Prevention programs based on the principles of Cognitive Behavioral Therapy
(CBT) have proven to be the most effective and most applied in preventing
depression among adolescents. Thus far, research has mainly focused on
effectiveness of *prevention packages* consisting of multiple CBT-elements.
Most common CBT-elements in existing programs are cognitive restructuring,
behavioral activation, relaxation and problem solving skills. It is unclear
which of these elements contribute to the positive prevention outcomes and how
these elements should be offered (i.e., what their optimal sequencing is). This
study proposes to evaluate the differential (cost-)effectiveness of different
types and sequences of CBT-elements in the prevention of depression among
adolescents.
Study objective
The primary objective is to investigate whether (and if so, which) type of
CBT-element (cognitive restructuring (CR), behavioral activation (BA),
relaxation (RE) and problem solving skills(PS)) is relevant for the positive
effect of CBT-programs on the level of depressive symptoms in adolescents. The
secondary objective is to investigate whether (and if so, which) sequence of
CBT-elements is relevant for the positive effect of CBT-programs on the level
of depressive symptoms in adolescents. In addition, it will be explored for
whom (i.e., moderation) and how (i.e., mediation) a given element, or set of
elements, is most effective. Besides, the cost-effectiveness of the prevention
of depression will be investigated.
Study design
A Randomized Controlled Trial with four conditions (all prevention programs).
Intervention
The prevention program will be developed by the researchers themselves in close
collaboration with experts and CBT-therapists. The program will be designed as
a Cognitive Behavioral Therapy, a therapy which has proven to be effective. It
will consist of twelve weekly sessions, each 45-60 minutes long. Prior to the
training an introductory meeting will take place, which lasts 30 minutes. For
each of the four CBT-elements a module of three sessions will be developed.
Each condition starts with a different module and contains a different sequence
of modules (condition 1: CR, BA, RE, PS; condition 2: BA, CR, RE, PS; condition
3: PS, BA, CR, RE; condition 4: RE, PS, BA, CR).
The prevention program will be given in same-sex groups consisting of six to
eight participants. It will be provided by certified alumni pedagogy and
psychology, who will trained and supervised by certified CB- therapists.
Study burden and risks
The potential value of the study is that we gain insight in the differential
effectiveness of the four most commonly used CBT-elements in the prevention of
depression among adolescents, and in their most optimal sequence. This
knowledge can be used for recommendations to optimize CBT-programs in the
prevention of adolescents with depressive symptoms. Possible direct benefits of
participating in this study, is that we offer adolescents with elevated levels
of depressive symptoms an effective program to prevent them from becoming
severely depressed. As an indirect positive effect, suicide can possibly be
prevented. A direct burden for the participating adolescents is that they have
to fill out questionnaires, will be interviewed and have to attend treatment
sessions. However, in our opinion this burden outweighs the possible benefits
of less depressed adolescents and a lower suicide risk.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are:
- age between 12-18 years old
- sufficient knowledge of the Dutch language
- (sub)clinical levels of depressive symptoms
Exclusion criteria
Exclusion criteria are:
- absence of adolescents* or parental permission (for subjects aged younger than 16)
- currently receiving treatment for psychological problems
- acute and severe suicidal thoughts and/or intentions
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 |
---|---|
Other | 6176 |
CCMO | NL59152.041.16 |