RECONNECT - Treatments for Complex PTSD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Copenhagen
About this trial
Complex PTSD (CPTSD) is a new diagnosis for which no established gold-standard treatment(s) yet exists. In this trial, three psychotherapies, Prolonged Exposure (PE), Eye Movement Desensitization and Reprocessing (EMDR), and Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR), are compared in a multisite trial. Methods: The study is a single-blinded, pragmatic, non-inferiority, multi-center randomized controlled trial (RCT) comparing ESTAIR, EMDR vs PE for CPTSD, each delivered as 18 weekly individual sessions. In total, 315 patients will be recruited from three outpatient clinics in the Capital Region of Denmark and randomized to one of the three intervention arms. The primary outcome is patient-rated CPTSD symptoms assessed with the International Trauma Questionnaire (ITQ); secondary outcomes include clinician-rated CPTSD symptoms assessed with the International Trauma interview (ITI), as well as dissociation, quality of life, attachment, interpersonal problems, and emotion regulation. Assessments are conducted before and after therapy (18 weekly sessions) treatment and at 6-month follow-up. Weekly patient- and clinician-rated outcomes are collected at every treatment session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, while fidelity assessors will monitor manual adherence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
concurrent psychotherapy
changed dosage on psychotropic medication
not fluent in Danish
Trial design
Design model
Parallel
Treatments tested in this trial
Prolonged Exposure
BehavioralAll treatments are delivered as 18 weekly, individual, 1-hour sessions by trauma clinicians (psychologists and psychiatrists), who will be trained and certified in all three interventions at the beginning of the project. To ensure treatment quality and adherence to the manuals, clinicians will receive bi-weekly video-based group supervision in the first year and then titrated to monthly in the second year and onwards. All three arms follow the same outpatient-clinic guidelines: 1) treatment must be offered within 30 days of referral; 2) treatment duration is 18 weeks; 3) treatment is discontinued if a patient misses four sessions. Each arm will be trained and supervised by a specialist in that treatment: the EMDR-arm by EMDR specialist Sophie Hallin Iuel-Brockdorff; the ESTAIR arm by Prof. Marylene Cloitre, who developed the intervention; and the PE-arm by PE-specialist Sandra Capaldi, a member of the late Prof. Edna Foa's team. Although PE serves as TAU, we have matched the clinical t
EMDR
BehavioralAll treatments are delivered as 18 weekly, individual, 1-hour sessions by trauma clinicians (psychologists and psychiatrists), who will be trained and certified in all three interventions at the beginning of the project. To ensure treatment quality and adherence to the manuals, clinicians will receive bi-weekly video-based group supervision in the first year and then titrated to monthly in the second year and onwards. All three arms follow the same outpatient-clinic guidelines: 1) treatment must be offered within 30 days of referral; 2) treatment duration is 18 weeks; 3) treatment is discontinued if a patient misses four sessions. Each arm will be trained and supervised by a specialist in that treatment: the EMDR-arm by EMDR specialist Sophie Hallin Iuel-Brockdorff; the ESTAIR arm by Prof. Marylene Cloitre, who developed the intervention; and the PE-arm by PE-specialist Sandra Capaldi, a member of the late Prof. Edna Foa's team. Although PE serves as TAU, we have matched the clinical t
ESTAIR
BehavioralAll treatments are delivered as 18 weekly, individual, 1-hour sessions by trauma clinicians (psychologists and psychiatrists), who will be trained and certified in all three interventions at the beginning of the project. To ensure treatment quality and adherence to the manuals, clinicians will receive bi-weekly video-based group supervision in the first year and then titrated to monthly in the second year and onwards. All three arms follow the same outpatient-clinic guidelines: 1) treatment must be offered within 30 days of referral; 2) treatment duration is 18 weeks; 3) treatment is discontinued if a patient misses four sessions. Each arm will be trained and supervised by a specialist in that treatment: the EMDR-arm by EMDR specialist Sophie Hallin Iuel-Brockdorff; the ESTAIR arm by Prof. Marylene Cloitre, who developed the intervention; and the PE-arm by PE-specialist Sandra Capaldi, a member of the late Prof. Edna Foa's team. Although PE serves as TAU, we have matched the clinical t
Treatment groups
225 Participants
are divided into 3 treatment groupsGroup A: Prolonged ExposureActive comparator 1 intervention
Group B: Eye Movement Desensitization and ReprocessingExperimental treatment 1 intervention
Group C: Enhanced Skills Training in Affective and Interpersonal RegulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
International Trauma Questionnaire
Self-report measuring CPTSD symptoms, with 18-items assessing for ICD-11 PTSD and complex PTSD (CPTSD). Respondents are asked to identify "the experience that troubles you the most" along with how long ago it occurred. Then they are asked to respond to symptom and functioning questions. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The scale ranges from 0 to 24 for PTSD symptoms and 0 to 24 for DSO symptoms, with higher scores reflecting greater symptom severity.
Time frame
From enrollment to 28 weeks post interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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