The primary aim is to evaluate the effectiveness of ACT your way, by comparing ACT your way to treatment as usual (TAU) in TAY. The secondary aim is to evaluate the cost-effectiveness of ACT your way, by comparing ACT your way to TAU in TAY. The…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The two main primary outcome measures are psychological flexibility (measured
with de AFQ-Y) and the number of diagnoses (measured with the SCID-5-Junior, a
semi-structured diagnostic interview).
Secondary outcome
Secondary outcomes are the presence of the primary disorder, psychopathology,
global functioning, quality of life, individual and societal functioning,
emotion regulation, personality problems, autonomy, stress, perfectionism,
self-esteem and self-compassion. Other study parameters are demographic
information, type and severity of problems, psychopathology of parents,
information about previous treatments and life events, treatment expectancy,
satisfaction with treatment, therapeutic alliance, information about drop-out,
treatment integrity and content of the treatment. Costs are registered in a
cost questionnaire.
Background summary
Transitional-age youth (TAY; aged 15 to 25) has recently been identified as a
group in need of special attention in mental health services. Studies show that
TAY experience more psychological problems than other age groups. An effective
intervention for this specific age group seems warranted. However, there is a
lack of interventions specifically developed for this age group. We propose a
transdiagnostic intervention, ACT your way, that can be used for a wide variety
of psychological problems and can also be used for chronic and/or recurrent
problems in this specific age group.
Study objective
The primary aim is to evaluate the effectiveness of ACT your way, by comparing
ACT your way to treatment as usual (TAU) in TAY. The secondary aim is to
evaluate the cost-effectiveness of ACT your way, by comparing ACT your way to
TAU in TAY. The third aim is to examine for whom ACT you way works best
(moderation analyses). The fourth aim is to investigate which factors mediate
ACT your way changes (mediation analyses).
Study design
The study is designed as a multi-center, randomized controlled trial.
Participants are randomly assigned to the ACT your way or TAU condition. Six
multiple informant (adolescent/young adult, parent, therapist) assessments will
be conducted: prior to the intervention (pre-treatment), after 3 sessions
(mediator 1), after 6 sessions (mediator 2), after 9 sessions (mediator 3),
immediately after the intervention (post-treatment) and 6 months after the
intervention (6-month follow-up). Assessments will include diagnostic
interviews, questionnaires and ratings (i.e., therapist and observational
ratings).
Intervention
ACT your way is an intervention based on Acceptance and Commitment Therapy
(ACT), that is not directed primarily at symptom reduction but at changing the
underlying mechanism of psychopathology, namely psychological inflexibility.
ACT you way consists of twelve weekly sessions. Therapists will be trained in
using ACT your way.
Study burden and risks
In our opinion, the risks associated with participation can be considered
negligible. The burden consists of structured clinical interviews and online
questionnaires, which are partly included in the standard diagnostic process of
the patient. The intervention that is offered, is independent of participation,
patients will receive this intervention whether or not they participate.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
(1) A primary diagnoses of any disorder (e.g., anxiety disorder, OCD, trauma,
depressive disorder, dysthymic disorder, ODD, CD or any combination of these)
(2) Aged 15 to 25 years
(3) Referred to one of the participating mental health institutions.
Exclusion criteria
(1) Insufficient knowledge of the Dutch language
(2) Acute suicide risk
(3) Drug abuse
(4) Absence of TAY or parental permission (for participants younger than 16)
(5) Estimated IQ below 80
(6) Unstable medication (i.e. the medication should be set before the start of
the intervention and should remain stable)
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 | NL78679.041.21 |
| Other | NL9642 |
| OMON | NL-OMON23521 |