The purpose of our study is to test the augmenting effect and mechanisms of change of exercise provided directly before in total 12 CBT sessions.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of our study is to compare changes in depressive symptoms
from pre to post CBT in the different conditions (TAU vs TAU+exercise) .
Secondary outcome
Our secondary aim is to explore psychological processes as mechanisms of change
of our intervention.
Explore whether the training transfer to:
* Anxiety symptoms and stress
* Self-esteem
* Sleep
* Physical activity
* Functioning
* Autobiographical memory bias
Explore possible mediating factors:
* Semantic memory
* Emotional memory
* Rumination
* CBT skills
Background summary
While cognitive behavioral therapy (CBT) has been proven to be effective in
reducing depressive symptoms,only appr. 60% of depressed patients respond
sufficiently to treatment (DeRubeis et al., 2005; Dimidjian et al., 2006) and
relapse rates are high (e.g. Hardeveld et al., 2010). Exercise is effective as
monotherapy for depression (Stathopoulou et al., 2006; Barbour et al., 2007),
in preventing relapse (Babyak et al., 2000), and in combination with other
therapies e.g. CBT (Abdollahi et al., 2017; Gary et al., 2010). Exercise yields
memory improvement (e.g. Blumenthal et al., 1999; Smith et al., 2010),
augmenting the learning effect of the post-exercise treatment session (Powers
et al., 2015). A recent meta-analysis shows that the combination of
psychological intervention (e.g. Cognitive Behavioral Therapy) and exercise is
especially effective in reducing depressive symptoms (Sukhato et al., 2017).
Hence, exercise is a strong treatment augmentation strategy that is currently
being implementing in few but some Dutch mental health care organizations. Its
effectiveness is however not yet evaluated in a Dutch setting and the working
mechanisms are not well understood thus far.
Study objective
The purpose of our study is to test the augmenting effect and mechanisms of
change of exercise provided directly before in total 12 CBT sessions.
Study design
Prospective, cross-over, randomized, multi center study with a
cluster-randomized stepped wedge design.
Study burden and risks
The burden is approximately 4 hours of filling out questionnaires and doing
computer tasks. Because the institutes are already providing exercise treatment
as standard care on some but not all locations, the conditions of the study
will be randomized over locations to be able to evaluate the added value of
exercise augmentation in the daily care setting. Hence, we are keeping close to
practice. There are no known risks associated with filling out the
questionnaires or doing the computer tasks.
Renier Postlaan 10
Nijmegen 6525GC
NL
Renier Postlaan 10
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult: age 18+
- Current depressive episode
- Participation CBT treatment with or without exercise (depending on location)
Exclusion criteria
A potential subject who meets any of the following criteria will not be invited for this study:
- Impossibility to obtain a valid informed consent
- Physical, cognitive, or intellectual impairments interfering with participation
- Lifetime manic episode
- Current psychosis
- Insufficient comprehension of the Dutch language
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 | NL65950.091.18 |