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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| PsyQ | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma-Focused Treatment | Active Comparator | Weekly sessions of prolonged exposure |
|
| Emotion Regulation Treatment | Active Comparator | weekly sessions of emotion regulation and skills training. |
|
| Intensive Trauma-Focused Treatment | Active Comparator | prolonged exposure, 3 sessions per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-focused treatment | Behavioral | Weekly sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptom severity | Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptom severity | total score on Inventory of Depressive Symptomatology (IDS) | 16 weeks |
| Quality of Life score | EQ5D5L total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willem Van Der Does, PdhD | head of department of clinical psychology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University - Institute of Psychology | Leiden | South Holland | 2333 AK | Netherlands | ||
| PsyQ department of psychotrauma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16382429 | Background | Zayfert C, Deviva JC, Becker CB, Pike JL, Gillock KL, Hayes SA. Exposure utilization and completion of cognitive behavioral therapy for PTSD in a "real world" clinical practice. J Trauma Stress. 2005 Dec;18(6):637-45. doi: 10.1002/jts.20072. | |
| Background | Hendriks, L., & Van Minnen, A. (2014). What to do with treatment failures: Intensive (Prolonged) Exposure treatment for PTSD. Presentation at EABCT Conference The Hague. | ||
| 24480899 |
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Individual participant data that underlie the results reported from this study may be shared, after deidentification
Beginning 6 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003887 | Desensitization, Psychologic |
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| Emotion regulation training | Behavioral | Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment |
|
| Intensive Trauma-focused treatment | Behavioral | Intensive version (3 sessions per week) of Trauma-focused treatment |
|
|
| 16 weeks |
| Responder rate | Meeting pre-defined criteria for remission | 16 weeks |
| Dropout rate | premature termination of treatment by patient | 16 weeks |
| Emotion regulation | ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS) | 16 weeks |
| Self-reported PTSD symptoms | Post-traumatic Stress Disorder Checklist (PCL-5) | 16 weeks |
| Interpersonal difficulties | ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP) | 16 weeks |
| Self-concept | ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS) | 16 weeks |
| The Hague |
| South Holland |
| 2333 AK |
| Netherlands |
| Background |
| Ehlers A, Hackmann A, Grey N, Wild J, Liness S, Albert I, Deale A, Stott R, Clark DM. A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy. Am J Psychiatry. 2014 Mar;171(3):294-304. doi: 10.1176/appi.ajp.2013.13040552. |
| 20595411 | Background | Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, Gan W, Petkova E. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010 Aug;167(8):915-24. doi: 10.1176/appi.ajp.2010.09081247. Epub 2010 Jul 1. |
| Background | Cloitre, M., Courtois, C.A., Ford, J.D., Green, B.L., Alexander, P., Briere, J. et al. (2012). The ISTSS Expert Consensus Treatment Guidelines for Complex PTSD in Adults. http://www.istss.org/AM/Template.cmf?Section=ISTSS_Complex_PTSD_Treatment_Guidelines&Template=/CM/ContentDisplay.cfm&ContentID=5185 |
| 34630934 | Derived | Oprel DAC, Hoeboer CM, Schoorl M, de Kleine RA, Cloitre M, Wigard IG, van Minnen A, van der Does W. Effect of Prolonged Exposure, intensified Prolonged Exposure and STAIR+Prolonged Exposure in patients with PTSD related to childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2021 Jan 15;12(1):1851511. doi: 10.1080/20008198.2020.1851511. eCollection 2021. |
| 30541492 | Derived | Oprel DAC, Hoeboer CM, Schoorl M, De Kleine RA, Wigard IG, Cloitre M, Van Minnen A, Van der Does W. Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment. BMC Psychiatry. 2018 Dec 12;18(1):385. doi: 10.1186/s12888-018-1967-5. |