The primary aim of the study is to determine the effectiveness and cost-effectiveness of I-TFT versus S-TFT as a first-line treatment for PTSD in people with multiple traumas. Hypotheses are: (1) I-TFT is non-inferior to S-TFT in terms of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychische stoornissen, t.w. posttraumatische stressstoornis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary clinical outcome parameter is the difference in response pattern in
terms of PTSD symptom severity on the clinical interview (CAPS-5) from baseline
to endpoints between experimental and control conditions. Main outcome
parameters for cost-effectiveness are the difference in health-related quality
of life (EQ-5D-5L) and costs from a societal perspective (TiC-P) from baseline
to endpoints between the experimental and control group.
Secondary outcome
Symptom complexity (defined as dissociative symptoms, moral injury, complex
PTSD symptoms, and comorbid personality traits), comorbidity (depression,
anxiety), verbal memory, experiential avoidance, and social support.
Background summary
Intensive trauma-focused therapy (I-TFT) is as effective as but shows faster
results than regular weekly trauma-focused therapy (S-TFT). However, according
to clinical guidelines, it should only be implemented as a third-line treatment
for PTSD. This RCT has been set up to determine if it is more cost-effective to
implement I-TFT as a first-line treatment as compared to regular weekly
treatment.
Study objective
The primary aim of the study is to determine the effectiveness and
cost-effectiveness of I-TFT versus S-TFT as a first-line treatment for PTSD in
people with multiple traumas. Hypotheses are: (1) I-TFT is non-inferior to
S-TFT in terms of effectiveness (PTSD reduction), (2) I-TFT is superior to
S-TFT in terms of cost-effectiveness.
Study design
Randomized controlled, single-blind, trial with two equal-sized treatment arms
(I-TFT and S-TFT) and pre-, post and follow-up (at 6 and 9 months from
baseline) measurements.
Intervention
The experimental group receives I-TFT, consisting of 2 50-min preparatory
sessions; 5 days of I-TFT (60-min Prolonged Exposure + 60-min Eye Movement
Desensitization & Reprocessing therapy) within two weeks; and 2 50-min
follow-up sessions. The control group receives S-TFT consisting of 16 weekly,
50-min evidence-based S-TFT sessions (Prolonged Exposure, Eye Movement
Desensitization & Reprocessing therapy, Brief Eclectic Psychotherapy for PTSD,
Narrative Exposure Therapy, or Imagery Rescripting). Both conditions have a
total treatment duration of 800 minutes.
Study burden and risks
In regular trauma-focused therapy the risk for adverse events and worsening of
symptoms is generally low. Studies into I-TFT have shown the risk for dropout
and adverse events to be comparable to, or lower than, S-TFT. The combination
of prolonged exposure therapy and EMDR therapy in intensive format as applied
in this study has also demonstrated comparable low risk of dropout and adverse
events in large uncontrolled studies. In the assessments and treatment sessions
(I-TFT and S-TFT), patients can experience it as burdensome to discuss their
traumatic experiences and PTSD symptoms. These are short-term effects and
usually decrease when the patient benefits from treatment. The five research
assessments during the study require time investment (around 10 hours,
excluding travel time) from the participants, but this is spread out over the 9
months of the study. All in all, we estimate the risks of participation in the
study to be minimal and the additional burden reasonable.
Nienoord 5
Diemen 1112XE
NL
Nienoord 5
Diemen 1112XE
NL
Listed location countries
Age
Inclusion criteria
(1) 18 years or older;
(2) PTSD diagnosis according to DSM-5 (CAPS-5);
(3) PTSD diagnosis based on >= 2 potentially traumatic events (PTEs);
(4) no prior treatment for PTSD (or less than 8 sessions);
(5) employed (working or on sick leave for <= two years).
Exclusion criteria
(1) current psychotic disorder, severe alcohol or substance use disorder, high
suicidal intent (MINI-S for DSM-5) with a concrete suicide plan; severe
aggressive behavior that poses danger for others;
(2) insufficient command of the Dutch language to be able to complete the
assessments.
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 |
|---|---|
| Other | LTR nummer volgt na goedkeuring studie |
| CCMO | NL86057.018.24 |