Stress Disorders, Post-TraumaticPT-STRESSNCT06279598
PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD
A study testing Prolonged Exposure therapy, Eye Movement Desensitization Reprocessing (EMDR) and Interpersonal Psychotherapy (IPT) in people with Stress Disorders, Post-Traumatic, run by University of Groningen at 1 site in Netherlands.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Prolonged Exposure therapy, Eye Movement Desensitization Reprocessing (EMDR) and Interpersonal Psychotherapy (IPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 31 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Dimence
Deventer
Maarten K van Dijk, PhD, +31 0570-604000, m.vandijk@dimence.nl
Dominique Jonkers, Master, +31 038-4692300, d.jonkers@dimence.nl
About this study
Official title: PT-STRESS Study: A Two-phase RCT Aimed at Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD; by Alternating Between Two Trauma-focused Treatments (EMDR/PE) or by Switching to Interpersonal Therapy (IPT)
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:
Read more
- Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?
- Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?
- In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?
- Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?
- Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?
Secondary goals:
- 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.
Read the detailed description
Background of the study:
The symptoms of posttraumatic stress disorder (PTSD) follow exposure to a traumatic event and are accompanied by significant functional limitations. PTSD is very common: a multinational study shows a lifetime prevalence of 3.9%. Effective treatment options exist for people with PTSD, with Eye Movement Desensitization and Reprocessing (EMDR) and Prolonged Exposure (PE; a specific form of trauma-focused Cognitive Behavioral Therapy, T-CBT) both listed as first-choice interventions in the Dutch standard of care for psychotrauma and stressor related disorders. About 40% of patients with PTSD do not benefit sufficiently from either of the aforementioned guideline treatments and about 18% of patients do not complete a trauma-focused treatment (treatment dropout). Knowledge about general predictors of treatment success in psychotherapy is limited, making it currently impossible to predict which patient will or will not benefit from which specific psychotherapeutic treatment (i.e., EMDR vs. PE). Little scientific knowledge exists about optimal follow-up treatment when patients insufficiently benefit from their initial treatment. For patients who drop out (e.g. from inability to tolerate exposure to traumatic memories) or do not benefit from exposure therapies, an alternative is to switch not to another proven effective trauma-focused intervention, but to a non-trauma-focused intervention. A suitable non-traumafocused treatment is Interpersonal Psychotherapy. Previous research suggests that IPT can be an effective first-line treatment option, but the effectiveness of IPT as a second treatment step for people with PTSD who have not responded to a trauma-focused psychotherapy has never been investigated. We hypothesize that IPT will yield greater symptom reduction and less dropout for patients with PTSD who do not respond to a course of trauma-focused psychotherapy compared to switching to another trauma-focused therapy.
Study population:
Subjects are recruited from Dimence, a mental health institution in the Netherlands. Subjects are recruited from patients who register for outpatient treatment within the Dimence division "Specialistic Diagnostics and Treatment" with a primary diagnosis of PTSD. It concerns adults between 18 and 65 years old, both men and women.
Intervention:
Half of initially non-responsive patients will be treated with the non-trauma-focused intervention interpersonal therapy (IPT) in phase 2 of the study. The first and second phases will offer the trauma-focused treatments Prolonged Exposure and EMDR.
- Interpersonal Psychotherapy (IPT) does not target the memories of a traumatic event but the interpersonal consequences of trauma, seeking to improve affective and interpersonal functioning that PTSD symptoms have disrupted. PTSD following a traumatic life event produces social withdrawal and a blunted, inhibited emotional life, disrupting interpersonal functioning. IPT helps benumbed patients recognize and tolerate their feelings so they can use them to handle their social environment, determine who is trustworthy, and mobilize protective social supports. IPT addresses patient emotions and their relationship to interpersonal interactions. As patients recognize their feelings, the therapist helps patients to name, normalize, and use their feelings rather than seeing them as an additional threat.
- In Prolonged Exposure, patients directly confront traumatic memories and cues and learn to expose themselves to terrifying but not dangerous stimuli to achieve habituation or extinction. The current study will use a protocol-based treatment of Cognitive Behavioral Therapy for PTSD that includes imaginal and in vivo exposure.
- In EMDR, patients are distracted from the traumatic memories by a dual attention task, usually using eye movements. This study will use a protocolled EMDR treatment for PTSD.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Major adverse events are not expected as these have not been documented in previous studies. The greatest burden on subjects is completing the questionnaires necessary to answer the primary research questions. In phase 1, this totals approximately 10.5 hours (with baseline measurement the most extensive and subsequent weekly measurements); for patients treated for an additional 8 weeks in phase 2, completing the questionnaires takes approximately another 6 hours. A patient participating in both treatment phases therefore spends a total of approximately 16.5 hours completing assessments. The prescription of patients taking medication must be stable prior to the study, and then not changed during the study, unless necessary due to a crisis or serious side effects. Patients receive treatment sessions twice a week, which is relatively frequent compared to usual treatment, but research shows that dropout is lower with two weekly sessions. Study participation further assures patients that the treatments they receive are performed as intended by the therapy-developer because therapists receive supervision and checks are made to ensure treatment integrity.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Prolonged Exposure therapy, Eye Movement Desensitization Reprocessing (EMDR), Interpersonal Psychotherapy (IPT)
- Keywords
- Psychotherapy, Trauma, Prolonged Exposure, Eye Movement Desensitization Reprocessing, Interpersonal Psychotherapy, Trauma-focused Cognitive Behavioral Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure therapyBehavioural
Also called Trauma-focused CBT
This concerns a form of psychotherapy for PTSD.
Eye Movement Desensitization Reprocessing (EMDR)Behavioural
This concerns a form of psychotherapy for PTSD.
Interpersonal Psychotherapy (IPT)Behavioural
This concerns a form of psychotherapy for PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure | Active comparator | Intervention: Prolonged Exposure therapy, 14 sessions of 60 minutes in 8 weeks. Receives: Behavioral: Prolonged Exposure therapy |
| Eye Movement Desensitization Reprocessing | Active comparator | Intervention: Eye Movement Desensitization Reprocessing (EMDR), 14 sessions of 60 minutes in 8 weeks. Receives: 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. Receives: Behavioral: Interpersonal Psychotherapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
The Dutch version of the CAPS-5 will be used as it is "the gold standard" in PTSD assessment. The CAPS-5 is a 30-item structured clinical interview that we will use, among other things, to determine the current (past month) diagnosis of PTSD and to assess improvement in symptoms since a previous CAPS administration.
Measured: 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)
The Dutch version of the ITQ will be used: "Internationale Trauma Vragenlijst" (ITV). The International Trauma Questionnaire (ITQ) is a self-report questionnaire consisting of 18 items that measures complex PTSD (C-PTSD) symptoms according to the diagnostic criteria of the 11th revision of the International Classification of Diseases (ICD-11; World Health Organization).
Measured: 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)
The Dutch version of the HADS will be used. The Hospital Anxiety and Depression Scale is a 14-item self-report questionnaire and can be used to measure levels of anxiety and depression.
Measured: 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)
The Dutch version of the MHC-SF will be used: the Dutch short-form Mental Health Continuum. The MHC-SF comprises 40 items that measure emotional well-being, psychological well-being and social well-being.
Measured: 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)
The Dutch version of the self-report questionnaire Positive and Negative Effects of Psychological Treatment (PNEP) will be used to assess both positive and possibly unfavorable and adverse events in psychological treatments. The Dutch questionnaire consists of 3 questions and 71 items.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completion20 May 2031 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dimence
- Responsible party
- Sponsor
- Investigators
- Maarten K van Dijk, PhD, Principal investigator, Dimence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279598
- Sponsor's protocol ID
- UniversityGroningen
- Acronym
- PT-STRESS
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boeschoten MA, Van der Aa N, Bakker A, Ter Heide FJJ, Hoofwijk MC, Jongedijk RA, Van Minnen A, Elzinga BM, Olff M. Development and Evaluation of the Dutch Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Eur J Psychotraumatol. 2018 Nov 22;9(1):1546085. doi: 10.1080/20008198.2018.1546085. eCollection 2018.
PubMed 30510643Loerinc AG, Meuret AE, Twohig MP, Rosenfield D, Bluett EJ, Craske MG. Response rates for CBT for anxiety disorders: Need for standardized criteria. Clin Psychol Rev. 2015 Dec;42:72-82. doi: 10.1016/j.cpr.2015.08.004. Epub 2015 Aug 14.
PubMed 26319194Mavranezouli I, Megnin-Viggars O, Daly C, Dias S, Welton NJ, Stockton S, Bhutani G, Grey N, Leach J, Greenberg N, Katona C, El-Leithy S, Pilling S. Psychological treatments for post-traumatic stress disorder in adults: a network meta-analysis. Psychol Med. 2020 Mar;50(4):542-555. doi: 10.1017/S0033291720000070. Epub 2020 Feb 17.
PubMed 32063234Coventry PA, Meader N, Melton H, Temple M, Dale H, Wright K, Cloitre M, Karatzias T, Bisson J, Roberts NP, Brown JVE, Barbui C, Churchill R, Lovell K, McMillan D, Gilbody S. Psychological and pharmacological interventions for posttraumatic stress disorder and comorbid mental health problems following complex traumatic events: Systematic review and component network meta-analysis. PLoS Med. 2020 Aug 19;17(8):e1003262. doi: 10.1371/journal.pmed.1003262. eCollection 2020 Aug.
PubMed 32813696Markowitz, J. C. (2021). Interpersoonlijke psychotherapie bij posttraumatische stressstoornis: Een nieuwe vorm van traumabehandeling (1e druk). Bohn Stafleu van Loghum.
Bleiberg KL, Markowitz JC. Interpersonal Psychotherapy for PTSD: Treating Trauma without Exposure. J Psychother Integr. 2019 Mar;29(1):15-22. doi: 10.1037/int0000113.
PubMed 31534308Levinson DB, Halverson TF, Wilson SM, Fu R. Less dropout from prolonged exposure sessions prescribed at least twice weekly: A meta-analysis and systematic review of randomized controlled trials. J Trauma Stress. 2022 Aug;35(4):1047-1059. doi: 10.1002/jts.22822. Epub 2022 Mar 12.
PubMed 35278229Hoppen TH, Lindemann AS, Morina N. Safety of psychological interventions for adult post-traumatic stress disorder: meta-analysis on the incidence and relative risk of deterioration, adverse events and serious adverse events. Br J Psychiatry. 2022 Nov;221(5):658-667. doi: 10.1192/bjp.2022.111. Epub 2022 Aug 12.
PubMed 35959698De Jongh, A., & Ten Broeke, E. (2019). Handboek EMDR. Een geprotocolleerde behandelmethode voor de gevolgen van psychotrauma (7e editie). Pearson.
Van Minnen, A., & Arntz, A. (2017). Protocollaire behandeling van patiënten met posttraumatische-stressstoornis (PTSS). Imaginaire exposure en exposure in vivo. In G. Keijsers, A. Van Minnen, M. Verbraak, K. Hoogduin, P. Emmelkamp (Reds), Protocollaire behandelingen voor volwassenen met psychische klachten deel 1 (pp. 311-352). Boom.
Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.
PubMed 28385165Boeschoten, M. A., Bakker, A., Jongedijk, R. A., & Olff, M. (2014). PTSD Checklist for DSM-5 (PCL-5). Scale available from Stichting Centrum '45, Arq Psychotrauma Expert Groep. https://www.psychotraumadiagnostics.centrum45.nl/nl/ptss.nl
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD. https://www.ptsd.va.gov
Nienhuis, F. J., & Giel, R. (2000). Mini-SCAN voor klinisch gebruik. Swets & Zeitlinger.
Eidhof, M., Ter Heide, F.J.J., Boeschoten, M.A., Olff, M. (2018). Internationale Trauma Vragenlijst: zelfrapportage vragenlijst voor ICD-11 PTSS en CPTSS. Nederlandstalige versie. Arq Psychotrauma Expert Groep. Scale available from http://www.psychotraumadiagnostics.centrum45.nl
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PT-STRESS Study: A Two-phase RCT Aimed at Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD; by Alternating Between Two Trauma-focused Treatments (EMDR/PE) or by Switching to Interpersonal Therapy (IPT)
- ClinicalTrials.gov ID
- NCT06279598
- Acronym / sponsor ID
- PT-STRESS / UniversityGroningen
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Psychotherapy, Trauma, Prolonged Exposure, Eye Movement Desensitization Reprocessing, Interpersonal Psychotherapy, Trauma-focused Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- Dimence
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 May 2031 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?
- Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?
- In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?
- Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?
- Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?
Secondary goals:
- 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.
Detailed description
Background of the study:
The symptoms of posttraumatic stress disorder (PTSD) follow exposure to a traumatic event and are accompanied by significant functional limitations. PTSD is very common: a multinational study shows a lifetime prevalence of 3.9%. Effective treatment options exist for people with PTSD, with Eye Movement Desensitization and Reprocessing (EMDR) and Prolonged Exposure (PE; a specific form of trauma-focused Cognitive Behavioral Therapy, T-CBT) both listed as first-choice interventions in the Dutch standard of care for psychotrauma and stressor related disorders. About 40% of patients with PTSD do not benefit sufficiently from either of the aforementioned guideline treatments and about 18% of patients do not complete a trauma-focused treatment (treatment dropout). Knowledge about general predictors of treatment success in psychotherapy is limited, making it currently impossible to predict which patient will or will not benefit from which specific psychotherapeutic treatment (i.e., EMDR vs. PE). Little scientific knowledge exists about optimal follow-up treatment when patients insufficiently benefit from their initial treatment. For patients who drop out (e.g. from inability to tolerate exposure to traumatic memories) or do not benefit from exposure therapies, an alternative is to switch not to another proven effective trauma-focused intervention, but to a non-trauma-focused intervention. A suitable non-traumafocused treatment is Interpersonal Psychotherapy. Previous research suggests that IPT can be an effective first-line treatment option, but the effectiveness of IPT as a second treatment step for people with PTSD who have not responded to a trauma-focused psychotherapy has never been investigated. We hypothesize that IPT will yield greater symptom reduction and less dropout for patients with PTSD who do not respond to a course of trauma-focused psychotherapy compared to switching to another trauma-focused therapy.
Study population:
Subjects are recruited from Dimence, a mental health institution in the Netherlands. Subjects are recruited from patients who register for outpatient treatment within the Dimence division "Specialistic Diagnostics and Treatment" with a primary diagnosis of PTSD. It concerns adults between 18 and 65 years old, both men and women.
Intervention:
Half of initially non-responsive patients will be treated with the non-trauma-focused intervention interpersonal therapy (IPT) in phase 2 of the study. The first and second phases will offer the trauma-focused treatments Prolonged Exposure and EMDR.
- Interpersonal Psychotherapy (IPT) does not target the memories of a traumatic event but the interpersonal consequences of trauma, seeking to improve affective and interpersonal functioning that PTSD symptoms have disrupted. PTSD following a traumatic life event produces social withdrawal and a blunted, inhibited emotional life, disrupting interpersonal functioning. IPT helps benumbed patients recognize and tolerate their feelings so they can use them to handle their social environment, determine who is trustworthy, and mobilize protective social supports. IPT addresses patient emotions and their relationship to interpersonal interactions. As patients recognize their feelings, the therapist helps patients to name, normalize, and use their feelings rather than seeing them as an additional threat.
- In Prolonged Exposure, patients directly confront traumatic memories and cues and learn to expose themselves to terrifying but not dangerous stimuli to achieve habituation or extinction. The current study will use a protocol-based treatment of Cognitive Behavioral Therapy for PTSD that includes imaginal and in vivo exposure.
- In EMDR, patients are distracted from the traumatic memories by a dual attention task, usually using eye movements. This study will use a protocolled EMDR treatment for PTSD.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Major adverse events are not expected as these have not been documented in previous studies. The greatest burden on subjects is completing the questionnaires necessary to answer the primary research questions. In phase 1, this totals approximately 10.5 hours (with baseline measurement the most extensive and subsequent weekly measurements); for patients treated for an additional 8 weeks in phase 2, completing the questionnaires takes approximately another 6 hours. A patient participating in both treatment phases therefore spends a total of approximately 16.5 hours completing assessments. The prescription of patients taking medication must be stable prior to the study, and then not changed during the study, unless necessary due to a crisis or serious side effects. Patients receive treatment sessions twice a week, which is relatively frequent compared to usual treatment, but research shows that dropout is lower with two weekly sessions. Study participation further assures patients that the treatments they receive are performed as intended by the therapy-developer because therapists receive supervision and checks are made to ensure treatment integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Active comparator | Behavioral: Prolonged Exposure therapyIntervention: Prolonged Exposure therapy, 14 sessions of 60 minutes in 8 weeks. |
| Eye Movement Desensitization Reprocessing | Active comparator | Behavioral: Eye Movement Desensitization Reprocessing (EMDR)Intervention: Eye Movement Desensitization Reprocessing (EMDR), 14 sessions of 60 minutes in 8 weeks. |
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal Psychotherapy (IPT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure therapyAlso: Trauma-focused CBTThis concerns a form of psychotherapy for PTSD. | Behavioural | Prolonged Exposure |
| Eye Movement Desensitization Reprocessing (EMDR)This concerns a form of psychotherapy for PTSD. | Behavioural | Eye Movement Desensitization Reprocessing |
| Interpersonal Psychotherapy (IPT)This concerns a form of psychotherapy for PTSD. | Behavioural | Interpersonal Psychotherapy |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.
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.
5 secondary outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 30510643Boeschoten MA, Van der Aa N, Bakker A, Ter Heide FJJ, Hoofwijk MC, Jongedijk RA, Van Minnen A, Elzinga BM, Olff M. Development and Evaluation of the Dutch Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Eur J Psychotraumatol. 2018 Nov 22;9(1):1546085. doi: 10.1080/20008198.2018.1546085. eCollection 2018.
- Background: PubMed 26319194Loerinc AG, Meuret AE, Twohig MP, Rosenfield D, Bluett EJ, Craske MG. Response rates for CBT for anxiety disorders: Need for standardized criteria. Clin Psychol Rev. 2015 Dec;42:72-82. doi: 10.1016/j.cpr.2015.08.004. Epub 2015 Aug 14.
- Background: PubMed 32063234Mavranezouli I, Megnin-Viggars O, Daly C, Dias S, Welton NJ, Stockton S, Bhutani G, Grey N, Leach J, Greenberg N, Katona C, El-Leithy S, Pilling S. Psychological treatments for post-traumatic stress disorder in adults: a network meta-analysis. Psychol Med. 2020 Mar;50(4):542-555. doi: 10.1017/S0033291720000070. Epub 2020 Feb 17.
- Background: PubMed 32813696Coventry PA, Meader N, Melton H, Temple M, Dale H, Wright K, Cloitre M, Karatzias T, Bisson J, Roberts NP, Brown JVE, Barbui C, Churchill R, Lovell K, McMillan D, Gilbody S. Psychological and pharmacological interventions for posttraumatic stress disorder and comorbid mental health problems following complex traumatic events: Systematic review and component network meta-analysis. PLoS Med. 2020 Aug 19;17(8):e1003262. doi: 10.1371/journal.pmed.1003262. eCollection 2020 Aug.
- BackgroundMarkowitz, J. C. (2021). Interpersoonlijke psychotherapie bij posttraumatische stressstoornis: Een nieuwe vorm van traumabehandeling (1e druk). Bohn Stafleu van Loghum.
- Background: PubMed 31534308Bleiberg KL, Markowitz JC. Interpersonal Psychotherapy for PTSD: Treating Trauma without Exposure. J Psychother Integr. 2019 Mar;29(1):15-22. doi: 10.1037/int0000113.
- Background: PubMed 35278229Levinson DB, Halverson TF, Wilson SM, Fu R. Less dropout from prolonged exposure sessions prescribed at least twice weekly: A meta-analysis and systematic review of randomized controlled trials. J Trauma Stress. 2022 Aug;35(4):1047-1059. doi: 10.1002/jts.22822. Epub 2022 Mar 12.
- Background: PubMed 35959698Hoppen TH, Lindemann AS, Morina N. Safety of psychological interventions for adult post-traumatic stress disorder: meta-analysis on the incidence and relative risk of deterioration, adverse events and serious adverse events. Br J Psychiatry. 2022 Nov;221(5):658-667. doi: 10.1192/bjp.2022.111. Epub 2022 Aug 12.
- BackgroundDe Jongh, A., & Ten Broeke, E. (2019). Handboek EMDR. Een geprotocolleerde behandelmethode voor de gevolgen van psychotrauma (7e editie). Pearson.
- BackgroundVan Minnen, A., & Arntz, A. (2017). Protocollaire behandeling van patiënten met posttraumatische-stressstoornis (PTSS). Imaginaire exposure en exposure in vivo. In G. Keijsers, A. Van Minnen, M. Verbraak, K. Hoogduin, P. Emmelkamp (Reds), Protocollaire behandelingen voor volwassenen met psychische klachten deel 1 (pp. 311-352). Boom.
- Background: PubMed 28385165Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.
- BackgroundBoeschoten, M. A., Bakker, A., Jongedijk, R. A., & Olff, M. (2014). PTSD Checklist for DSM-5 (PCL-5). Scale available from Stichting Centrum '45, Arq Psychotrauma Expert Groep. https://www.psychotraumadiagnostics.centrum45.nl/nl/ptss.nl
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maarten K van Dijk, PhD principal investigator
Dimence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure therapy, Eye Movement Desensitization Reprocessing (EMDR) and Interpersonal Psychotherapy (IPT) in people with Stress Disorders, Post-Traumatic, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten K van Dijk, PhD (+31 0570-604000, m.vandijk@dimence.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06279598, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.