PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD

NCT06279598 | Recruiting

• 1 other identifier: UniversityGroningen
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized. Key questions:

• Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;
• Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;
• Investigating how much the quality of the therapeutic alliance influences outcomes. Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Psychotherapy; Trauma; Prolonged Exposure; Eye Movement Desensitization Reprocessing; Interpersonal Psychotherapy; Trauma-focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  The primary outcome measure for the effectiveness of the treatment in both phases is symptom reduction (less burden of PTSD symptoms) measured with the PTSD checklist for the DSM-5 (PCL-5). The Dutch version of the PCL-5 will be used, the PCL-5 is administered at baseline and repeated weekly. The PCL-5 is a self-report questionnaire of 20 items about the DSM-5 symptoms of PTSD. This measure will be used to monitor symptom change during and after treatment in both phases of the study.

  Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.

Secondary Outcomes (5)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).

• International Trauma Questionnaire (ITQ)

  Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).

• Hospital Anxiety and Depression Scale (HADS)

  Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.

• Mental Health Continuum Short Form (MHC-SF)

  Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).

• Positive and Negative Experiences of Psychotherapy questionnaire (PNEP)

  Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).

Other Outcomes (20)

• Age

  Measured at baseline.

• Gender

  Measured at baseline.

• Education

  Measured at baseline.

Study Arms (3)

Prolonged Exposure

ACTIVE COMPARATOR

Intervention: Prolonged Exposure therapy, 14 sessions of 60 minutes in 8 weeks.

Behavioral: Prolonged Exposure therapy

Eye Movement Desensitization Reprocessing

ACTIVE COMPARATOR

Intervention: Eye Movement Desensitization Reprocessing (EMDR), 14 sessions of 60 minutes in 8 weeks.

Behavioral: Eye Movement Desensitization Reprocessing (EMDR)

Interpersonal Psychotherapy

EXPERIMENTAL

Intervention: Interpersonal Psychotherapy (IPT), 14 sessions of 60 minutes in 8 weeks. In phase 2 of the study for treatment non-responders, IPT is studied as an alternative switching option compared to the switch of the aforementioned trauma-focused forms of psychotherapy.

Behavioral: Interpersonal Psychotherapy (IPT)

Interventions

Prolonged Exposure therapy BEHAVIORAL

This concerns a form of psychotherapy for PTSD.

Also known as: Trauma-focused CBT

Prolonged Exposure

Eye Movement Desensitization Reprocessing (EMDR) BEHAVIORAL

This concerns a form of psychotherapy for PTSD.

Eye Movement Desensitization Reprocessing

Interpersonal Psychotherapy (IPT) BEHAVIORAL

This concerns a form of psychotherapy for PTSD.

Interpersonal Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 18 and 65 who were classified with a primary diagnosis of PTSD (based on the DSM-5 criteria).
• Adults who are willing to participate in the study (informed consent)

You may not qualify if:

• Insufficient proficiency in the Dutch language.
• Patients who cannot follow the treatment protocol (for example due to prolonged absence) are excluded from the study.
• Patients who use medication that is not stable. If properly set to the last prescribed medication by the doctor there will be advised to continue and referably not change the medication and its dose during treatment, unless necessary in connection with side effects, crisis, etc.
• Patients that already received an evidence-based form of trauma-oriented treatment for PTSD in the past year and for sufficient treatment duration, in accordance to the Dutch professional practice guidelines (reference: Akwa GGZ (2020, December 1). GGZ Standaarden. Psychotrauma- en stressorgerelateerde stoornissen. Retrieved September 29, 2022, from https://www.ggzstandaarden.nl/zorgstandaarden/psychotrauma-en-stressorgerelateerde-stoornissen/introductie).
• Patients with serious suicidality that requires acute intervention and structural addition of additional treatment interventions.
• Patients with an intellectual disability.
• Patients with a serious addiction as a comorbid problem.
• Patients with an acute mania or a psychotic state.

Sponsors & Collaborators

• University of Groningen: lead
• Dimence: collaborator

Study Sites (1)

Dimence

Deventer, Netherlands

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maarten K van Dijk, PhD

  Dimence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten K van Dijk, PhD

CONTACT

+31 0570-604000; m.vandijk@dimence.nl

Dominique Jonkers, Master

CONTACT

+31 038-4692300; d.jonkers@dimence.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 20, 2031
• Study Completion (Estimated): August 31, 2032
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)