The aim of this project is to investigate the (cost)effectiveness of two innovative forms of trauma-focused therapy for patients with CA-PTSD. The effects will be assessed post-treatment and after a 6 and 12 months follow-up in an intention-to-treat…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD symptom severity.
Secondary outcome
Responder rate (Jacobson & Truax criteria), dropout rate, depression severity,
emotion regulation skills; interpersonal skills; self-concept and quality of
life.
Background summary
In the Dutch treatment guidelines for anxiety disorders, trauma-focused
treatment such as Prolonged Exposure (PE), is recommended as first treatment
option for PTSD. However, despite these clear guidelines, there is an ongoing
debate among researchers and clinicians whether these guidelines fit patients
with childhood abuse related PTSD (CA-PTSD). Non-attendance and high dropout
rates in this particular patient group seem common. The general aim of the
present project is to test the effectiveness and tolerability of two innovative
forms of trauma-focused treatment in patients with chronic, childhood-related
PTSD: phase-based therapy (emotion regulation skills training followed bij PE;
STAIR/PE) and intensive PE (i-PE). We expect both treatment innovations to have
fewer dropouts, to lead to faster symptom reduction and more favorable long
term outcomes and consequently, lower treatment costs.
Study objective
The aim of this project is to investigate the (cost)effectiveness of two
innovative forms of trauma-focused therapy for patients with CA-PTSD. The
effects will be assessed post-treatment and after a 6 and 12 months follow-up
in an intention-to-treat analysis. Results will be disseminated and included in
treatment guidelines. The ultimate goal is to improve quality of care and
contribute to treatment innovation for this severely ill target population.
Study design
Multicenter randomized controlled trial.
Intervention
STAIR/PE: 8 weekly sessions skills training, 8 sessions PE.
i-TFT: TFT delivered in 12 sessions over the course of 4 weeks, and 2 booster
sessions.
Study burden and risks
Each participant will receive treatment. Based on previous results, it is
expected that all three conditions will be effective for patients. No
significant risks are associated with participation. In case of symptom
persistence or increase contact with a therapist or an independent expert and
doctor (psychiatrist) is available for participants. The burden for patients
involve additional measurements. Benefits of participation are extended
diagnostic and evaluative information, reduction of mental health issues as
symptoms of PTSD and depression and knowledge on specialized treatments for
this patient group.
Wassenaarseweg 35 35
Leiden 2342AX
NL
Wassenaarseweg 35 35
Leiden 2342AX
NL
Listed location countries
Age
Inclusion criteria
-Age >= 18 years
-Multiple traumata related to childhood sexual/physical abuse that occurred <=
17 years of age, and committed by a primary caretaker or an authority figure as
index event
-Diagnosis of PTSD according to DSM-5, including at least one specific discrete
memory of a traumatic event
- PTSD Symptom severity: CAPS score > 50.
- Sufficient fluency in Dutch to complete the treatment and research protocols.
Exclusion criteria
- Involved in legal procedures concerning admission or stay in The Netherlands
- Pregnancy
- Severe non-suicidal self-injury (NSSI) in the last two months (hospital
referral required)
- Severe suicidality
- Alcohol or drug dependence/abuse in last 2 months
- Cognitive impairment (estimated IQ score < 70).
- Changes in psychotropic medication in the 2 months prior to inclusion.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL57984.058.16 |