Dataset Information

Phase-based treatment versus immediate trauma-focused treatment for post-traumatic stress disorder due to childhood abuse: randomised clinical trial

ABSTRACT:

Background

It is unclear whether people with post-traumatic stress disorder (PTSD) and symptoms of complex PTSD due to childhood abuse need a treatment approach different from approaches in the PTSD treatment guidelines.

Aims

To determine whether a phase-based approach is more effective than an immediate trauma-focused approach in people with childhood-trauma related PTSD (Netherlands Trial Registry no.: NTR5991).

Method

Adults with PTSD following childhood abuse were randomly assigned to either a phase-based treatment condition (8 sessions of Skills Training in Affect and Interpersonal Regulation (STAIR), followed by 16 sessions of eye-movement desensitisation and reprocessing (EMDR) therapy; n = 57) or an immediately trauma-focused treatment condition (16 sessions of EMDR therapy; n = 64). Participants were assessed for symptoms of PTSD and complex PTSD, and other forms of psychopathology before, during and after treatment and at 3- and 6-month follow-ups.

Results

Data were analysed with linear mixed models. No significant differences between the two treatments on any variable at post-treatment or follow-up were found. Post-treatment, 68.8% no longer met PTSD diagnostic criteria. Self-reported PTSD symptoms significantly decreased for both STAIR–EMDR therapy (d = 0.93) and EMDR therapy (d = 1.54) from pre- to post-treatment assessment, without significant difference between the two conditions. No differences in drop-out rates between the conditions were found (STAIR–EMDR 22.8% v. EMDR 17.2%). No study-related adverse events occurred.

Conclusions

This study provides compelling support for the use of EMDR therapy alone for the treatment of PTSD due to childhood abuse as opposed to needing any preparatory intervention.

SUBMITTER: van Vliet N

PROVIDER: S-EPMC8612023 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Knowledge of treatment predictors and moderators is important for improving the effectiveness of treatment for PTSD due to childhood abuse.Objective: The first aim of this study was to test the potential predictive value of variables commonly associated with PTSD resulting from a history of repeated childhood abuse, in relation to treatment outcomes. The second aim was to examine if complex PTSD symptoms act as potential moderators between treatment conditions and outcomes.Method: Data were obtained from a randomized controlled trial comparing a phase-based treatment (Skills Training in Affect and Interpersonal Regulation [STAIR] followed by Eye Movement Desensitization and Reprocessing [EMDR] therapy; n = 57) with a direct trauma-focused treatment (EMDR therapy only; n = 64) in people with PTSD due to childhood abuse. The possible predictive effects of the presence of borderline personality disorder, dissociative symptoms, and suicidal and self-injurious behaviours were examined. In addition, it was determined whether symptoms of emotion regulation difficulties, self-esteem, and interpersonal problems moderated the relation between the treatment condition and PTSD post-treatment, corrected for pre-treatment PTSD severity.Results: Pre-treatment PTSD severity proved to be a significant predictor of less profitable PTSD treatment outcomes. The same was true for the severity of dissociative symptoms, but only post-treatment, and not when corrected for false positives. Complex PTSD symptoms did not moderate the relationship between the treatment conditions and PTSD treatment outcomes.Conclusions: The current findings suggest that regardless of the common comorbid symptoms studied, immediate trauma-focused treatment is a safe and effective option for individuals with childhood-related PTSD. However, individuals experiencing severe symptoms of PTSD may benefit from additional treatment sessions or the addition of other evidence-based PTSD treatment approaches. The predictive influence of dissociative sequelae needs further research.The study design was registered in The Dutch trial register (https://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 5991) NTR5991 and was approved by the medical ethics committee of Twente NL 56641.044.16 CCMO.

Project description:BackgroundThe treatment of posttraumatic stress disorder (PTSD) related to a history of sexual and/or physical abuse in childhood is the subject of international debate, with some favouring a phase-based approach as their preferred treatment, while others argue for immediate trauma-focused treatment. A history of (chronic) traumatisation during childhood has been linked to the development of distinct symptoms that are often labelled as symptoms of complex PTSD. Many therapists associate the presence of symptoms of complex PTSD with a less favourable treatment prognosis. The purpose of this study is to determine whether a phase-based approach is more effective than stand-alone trauma-focused therapy in individuals with PTSD and possible symptoms of complex PTSD resulting from a history of repeated sexual and/or physical abuse in childhood. An additional aim is to investigate moderators, predictors of treatment (non) response and drop-out.MethodThe sample consists of patients between 18 and 65 years old with a diagnosis of PTSD who report a history of repeated sexual and/or physical abuse in childhood (N?=?122). Patients will be blindly allocated to either 16 sessions of eye movement desensitization and reprocessing (EMDR) therapy preceded by a stabilization phase (eight sessions of Skills Training in Affect and Interpersonal Regulation (STAIR)) or only 16 sessions of EMDR therapy. Assessments are carried out pre-treatment, after every eighth session, post-treatment, and at 3 and 6 months follow up. The main parameter will be the severity of PTSD symptoms (PTSD Symptoms Scale-Self Report). Secondary outcome variables are the presence of a PTSD diagnosis (Clinician-Administered PTSD Scale for DSM-5), severity of complex PTSD symptoms (Structured Interview for Disorders of Extreme Stress-Revised and symptoms-specific questionnaires), changes in symptoms of general psychopathology (Brief Symptom Inventory), and quality of life (Euroqol-5D). Health care consumption and productivity loss in patients will also be indexed.DiscussionThe study results may help to inform the ongoing debate about whether a phase-based approach has added value over immediate trauma-focused therapy in patients suffering from PTSD due to childhood abuse. Furthermore, the results will contribute to knowledge about the safety, efficacy, and cost-effectiveness of treatments in this target group.Trial registrationNederlands Trialregister, NTR5991 . Registered on 23 august 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5991.

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Project description:IntroductionSuccess rates of psychotherapy in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM) are limited.Methods and analysisObserver-blind multicentre randomised clinical trial (A-1) of 4-year duration comparing enhanced methods of STAIR Narrative Therapy (SNT) and of trauma-focused psychodynamic therapy (TF-PDT) each of up to 24 sessions with each other and a minimal attention waiting list in PTSD-CM. Primary outcome is severity of PTSD (Clinician-Administered PTSD Scale for DSM-5 total) assessed by masked raters. For SNT and TF-PDT, both superiority and non-inferiority will be tested. Intention-to-treat analysis (primary) and per-protocol analysis (secondary). Assessments at baseline, after 10 sessions, post-therapy/waiting period and at 6 and 12 months of follow-up. Adult patients of all sexes between 18 and 65 years with PTSD-CM will be included. Continuing stable medication is permitted. To be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions and concurrent psychotherapy. To be assessed for eligibility: n=600 patients, to be e randomly allocated to the study conditions: n=328. Data management, randomisation and monitoring will be performed by an independent European Clinical Research Infrastructure Network (ECRIN)-certified data coordinating centre for clinical trials (KKS Marburg). Report of AEs to a data monitoring and safety board. Complementing study A-1, four inter-related add-on projects, including subsamples of the treatment study A-1, will examine (1) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1); (2) biological parameters (B-2, eg, DNA damage, reactive oxygen species and telomere shortening); (3) structural and functional neural changes by neuroimaging (B-3) and (4) cost-effectiveness of the treatments (B-4, costs and utilities).Ethics and disseminationApproval by the institutional review board of the University of Giessen (AZ 168/19). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.Trial registration numberDRKS 00021142.

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