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ABSTRACT
Background: MDMA-assisted psychotherapy (MDMA-AP) is a combined psychotherapeutic and pharmacologic intervention that shows promise in the treatment of posttraumatic stress disorder (PTSD). Although therapeutic alliance has been established as a key predictor across psychotherapies and is emphasised within MDMA-AP treatment manuals, research has not yet examined the relationship between therapeutic alliance and MDMA-AP treatment outcomes.
Objective: Examine whether therapeutic alliance predicts changes in PTSD symptoms following MDMA-AP.
Method: Twenty-three individuals with chronic PTSD participated in a MDMA-AP clinical trial that included a randomised (MDMA vs. placebo) and open-label phase. The present analyses focused on participants who were administered MDMA over the course of the randomised and open-label phases (n = 22). Therapeutic alliance was assessed using the Working Alliance Inventory at sessions baseline (pre-session 3) and sessions 4 and 9. PTSD symptoms were assessed using the Clinician Administered PTSD Scale and the Impact of Events Scale-Revised.
Results: Controlling for baseline clinician-assessed PTSD severity, therapeutic alliance at sessions 4 and 9 (but not baseline) significantly predicted post-MDMA-AP clinician-assessed PTSD severity. Controlling for baseline self-reported PTSD severity, therapeutic alliance at baseline (although this did not survive correction for multiple comparisons) and sessions 4 and 9 predicted post-MDMA-AP self-reported PTSD severity.
Conclusions: The present results provide the first preliminary evidence for the relationship between the therapeutic alliance and treatment outcomes within MDMA-AP for PTSD. These findings highlight the important role of psychotherapy, and common psychotherapeutic factors, within MDMA-AP. Replication in studies with larger and more diverse clinical samples remain necessary.
Trial registration: ClinicalTrials.gov identifier: NCT00090064.
HIGHLIGHTS
Among individuals with chronic posttraumatic stress disorder, therapeutic alliance predicted changes in posttraumatic stress disorder severity following MDMA-assisted psychotherapy.
Therapeutic alliance may play a key role in facilitating therapeutic improvement within MDMA-assisted psychotherapy.
Further research remains necessary to confirm these preliminary findings and the role of therapeutic alliance in MDMA-assisted psychotherapy.
Antecedentes: La psicoterapia asistida por MDMA (MDMA-AP por sus siglas en inglés) es una combinación de intervención psicoterapéutica y farmacológica que muestra ser prometedora en el tratamiento del trastorno de estrés postraumático (TEPT). Aunque la alianza terapéutica ha sido bien establecida como un predictor clave a través de las psicoterapias y se enfatiza en los manuales de tratamiento MDMA-AP, la investigación aún no ha examinado la relación entre la alianza terapéutica y los resultados del tratamiento MDMA-AP.
Objetivo: Examinar si la alianza terapéutica predice cambios en los síntomas de TEPT después de MDMA-AP.
Método: Veintitrés individuos con TEPT crónico participaron en un ensayo clínico de MDMA-AP que incluyó una fase aleatorizada (MDMA vs placebo) y abierta. El presente análisis se centra en los participantes a los que se les administró MDMA en el curso de las fases aleatorias y abiertas (n = 22). La alianza terapéutica se evaluó utilizando el Inventario de Alianza de Trabajo en las sesiones iniciales (antes de la sesión 3) y en las sesiones 4 y 9. Los síntomas de TEPT se evaluaron utilizando la Escala de TEPT administrada por el Clínico y la Escala Revisada del Impacto de los Eventos.
Resultados: Al controlar según la severidad del TEPT evaluada por el clínico al inicio, la alianza terapéutica en la sesión 4 y 9 (pero no la inicial) predijo significativamente la severidad del TEPT post tratamiento evaluada por el clínico post MDMA-AP. Al controlar al inicio según la severidad del TEPT por auto-reporte, la alianza terapéutica al inicio (aunque esto no sobrevivió a la corrección para comparaciones múltiples) y en las sesiones 4 y 9 predijeron la severidad del TEPT auto-reportada post-MDMA-AP.
Conclusiones: Los resultados actuales proporcionan la primera evidencia preliminar de la relación entre la alianza terapéutica y los resultados del tratamiento en MDMA-AP para TEPT. Estos hallazgos resaltan el importante papel de la psicoterapia y los factores psicoterapéuticos comunes, dentro de la MDMA-AP. Sigue siendo necesario la replicación en estudios con muestras clínicas mas grandes y diversas.
Acknowledgements
We thank MAPS for sharing these data, as well as the study participants, coordinators, and therapists for their contribution to this research.
Author contributions
MCM and ATM conducted the clinical trial. RJZ and AW contributed the conceptualisation of the manuscript. RJZ and HK conducted the statistical analyses. RJZ wrote the original draft of the manuscript. All authors reviewed and edited the manuscript.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The data that support the findings of this study are available from the sponsor (MAPS). However, restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with the permission of MAPS at http://maps.org/datause. All requests for raw and analysed data are promptly reviewed by the sponsor delegate and trial organiser, MAPS PBC, to verify if the request is subject to any confidentiality obligations. Patient-related data not included in the paper were generated as part of clinical trials and may be subject to patient confidentiality. Any data that can be shared will be released via a data use agreement.