Improving PTSD Treatments for Adults With Childhood Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse.

We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma

NCT01443182

Posttraumatic Stress Disorder (PTSD)

COMPLETED NA

First-Line Intervention for PTSD - Intensive Treatment

NCT06700590

PTSD - Post Traumatic Stress Disorder

RECRUITING NA

Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth

NCT05226481

Trauma Mental Health Disorder PTSD +1 more

COMPLETED

Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects

NCT07052474

PTSD - Post Traumatic Stress Disorder

RECRUITING

Effectiveness of Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder

NCT06048172

Post Traumatic Stress Disorder PTSD Psychosis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Dutch treatment guidelines recommend trauma-focused treatment (TFT) for PTSD. In TFT, patients are exposed to trauma reminders that they typically avoid, until their emotional reactions decline. This treatment has been found very effective for some patients but there is much room for improvement, particularly in PTSD related to childhood abuse (CA-PTSD). Symptom exacerbation, non-attendance and dropout rates of up to 40% have been observed in patients with CA-PTSD.

Two alternative treatments have been proposed. Firstly, TFT may be preceded by emotion regulation and interpersonal skills training. This is called phase-based treatment (PBT). The rationale is that patients with CA-PTSD have affect regulation and interpersonal problems that interfere with effective delivery of TFT. These problems are rooted in the detrimental developmental effects of abuse (often by an attachment figure). PBT indeed resulted in more favorable outcomes and fewer dropouts. In international guidelines, PBT was recently recommended as treatment of choice for patients with CA-PTSD and comorbidity.

Another innovative treatment is intensive TFT (i-TFT), which means delivering TFT in 4 instead of 16 weeks. The condensed format enhances learning and prevents the buildup of anticipatory anxiety, which in turn affects the patients' motivation. Patients with CA-PTSD are also characterized by high psychosocial stressors, leading to problems with treatment attendance and compliance. The condensed format may improve motivation, attendance and compliance. I-TFT was recently tested in a case series in patients with CA-PTSD and in a randomized controlled trial (RCT) with patients with adulthood-related PTSD. Both studies had very low dropout rates (0-3%) and fast recovery.

The aim of the current study is to investigate the (cost)effectiveness of two innovative forms of trauma-focused therapy for patients with CA-PTSD: phase-based therapy (emotion regulation skills training followed bij PE) and intensive PE (i-PE). 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trauma-Focused Treatment

Weekly sessions of prolonged exposure

Group Type ACTIVE_COMPARATOR

Trauma-focused treatment

Intervention Type BEHAVIORAL

Weekly sessions

Emotion Regulation Treatment

weekly sessions of emotion regulation and skills training.

Group Type ACTIVE_COMPARATOR

Trauma-focused treatment

Intervention Type BEHAVIORAL

Weekly sessions

Emotion regulation training

Intervention Type BEHAVIORAL

Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment

Intensive Trauma-Focused Treatment

prolonged exposure, 3 sessions per week

Group Type ACTIVE_COMPARATOR

Intensive Trauma-focused treatment

Intervention Type BEHAVIORAL

Intensive version (3 sessions per week) of Trauma-focused treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trauma-focused treatment

Weekly sessions

Intervention Type BEHAVIORAL

Emotion regulation training

Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment

Intervention Type BEHAVIORAL

Intensive Trauma-focused treatment

Intensive version (3 sessions per week) of Trauma-focused treatment

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cognitive Behavior therapy Prolonged exposure Imaginal exposure Intensive Prolonged Exposure

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of PTSD according to DSM-5, including at least one specific discrete memory of a traumatic event
* Multiple traumata related to childhood sexual/physical abuse that occurred before 18 years of age, and committed by a primary caretaker or an authority figure as index event
* Symptom severity: CAPS score \> 25
* Sufficient fluency in Dutch to complete the treatment and research protocols

Exclusion Criteria

* Involved in legal procedures concerning admission or stay in The Netherlands
* Involvement in compensation issues
* Pregnancy
* Severe non-suicidal self-injury (NSSI) in the last two months (hospital referral required)
* Suicidality in the last 2 months
* Alcohol or drug dependence in last 2 months
* Cognitive impairment (estimated IQ \< 70)
* Changes in psychotropic medication in the two months prior to inclusion
* Current psychological treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No