To determine the unique contribution of physical activity on PTSD treatment outcome within an intensive TFT programme. In addition, the study aims to investigate the underlying biological and psychological pathways of the effects of physical…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the change in PTSD symptoms from pre- to
posttreatment and at 6-month follow-up, measured with the
Clinician-Administered PTSD Scale (CAPS-5) and the PTSD Checklist for DSM-5
(PCL-5).
Secondary outcome
The secondary outcome measures are the underlying biological and psychological
mediators, measured with the Cortisol Awakening Response (CAR), inflammation
levels, DNA methylation, Insomnia Severity Index (ISI), Depressive
Symptomatology Self-Report (QIDS-SR), Difficulties in Emotion Regulation Scale
(DERS), Dissociative Experiences Scale-II (DES-II), and the Anxiety Sensitivity
Index (ASI).
Background summary
Several empirical studies revealed a positive influence of supplemental
physical activity on the treatment of individuals suffering from post-traumatic
stress disorder (PTSD). In accordance with the positive results, new intensive
trauma-focused treatment (TFT) programmes have been developed for people with
PTSD that incorporate physical activity often in combination with
evidence-based TFT*s such as prolonged exposure (PE) and eye movement
desensitization and reprocessing (EMDR) therapy. However, the unique
contribution of physical activity in the treatment of PTSD symptoms has never
been investigated in a controlled manner in the context of a brief intensive
TFT programme.
Study objective
To determine the unique contribution of physical activity on PTSD treatment
outcome within an intensive TFT programme. In addition, the study aims to
investigate the underlying biological and psychological pathways of the effects
of physical activity on PTSD symptoms.
Study design
The study is a randomized controlled trial (RCT) with two arms, comparing the
change in PTSD symptoms of a physical activity and an active control condition
from baseline to posttreatment and at 6-month follow-up.
Intervention
Participants in both conditions will receive the same intensive TFT lasting 8
days within 2 consecutive weeks, in which daily TFT-sessions, PE and EMDR
therapy, and psycho-education are combined. The amount of physical activity
will differ per condition. The physical activity condition is meant to induce
daily physical activity with 60-70% of a person*s maximum heart rate. In the
active control condition no physical activity besides TFTs is performed.
Study burden and risks
All patients will receive the same effective evidence-based TFT that consists
of PE and EMDR therapy. Although physical activity is not a standard component
within first-line evidence-based treatments for PTSD, there are no indications
that the addition of physical activity yields any risks for PTSD patients. For
example, physical activity is a standard part of the TFT programme at PSYTREC
that has proven to be effective for patients undergoing this treatment since
2015 (Van Woudenberg, et al. 2018). Furthermore, there are no additional risks
in the administration of the questionnaires as patients with PTSD in general
report questionnaire participation as beneficial (Jaffe, et al. 2015). The
biological samples are also very safe and easy assessments in which the
patients perform the action themselves so that they retain full control.
Professor Bronkhorstlaan 2
Bilthoven 3723 MB
NL
Professor Bronkhorstlaan 2
Bilthoven 3723 MB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, subjects must meet all of
the following criteria: (1) a diagnosis of PTSD based on the
Clinician-Administered PTSD Scale (CAPS-5), (2) being at least 18 years old (3)
sufficient knowledge of the Dutch language to undergo treatment.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from
participation in this study: (1) a suicide attempt less than three months prior
to treatment, (2) being medically unfit to participate in the physical activity
intervention operationalized as not being able to walk for at least 30 minutes
(e.g., physical impairments that necessitate the use of wheelchair).
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 | NL70812.029.19 |