The Course and Outcome of Integreated Trauma and Addiction Treatment Between PTSD and CPTSD

NCT06588309 | Recruiting

• 1 other identifier: CPTSS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In the ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD) are distinguished. CPTSD is associated with early childhood traumatization and more severe symptom patterns. Research thus far confirms that PTSD and CPTSD are two related but different concepts, but it's still unclear what the clinical relevance of this differentiation is. In addiction care approximately one out of three patients suffer from (C)PTSD. It's unclear if in patients with a substance use disorder (SUD) comorbid CPTSD results in poorer treatment outcomes compared to comorbid PTSD.

Conditions

PTSD; Addiction

Keywords

PTSD; CPTSD; Addiction; EMDR; CRA

Outcome Measures

Primary Outcomes (2)

• PTSD symptom severity

  Changes over time in PTSD symptom severity between participants with comorbid PTSD and CPTSD from T0-T2 as measured by the PCL-5.

  September 2023- September 2025

• Proportion of lost of the (C)PTSD diagnosis

  Proportion loss of (C)PTSD diagnoses in EMDR completers (as determined by their therapists) in both groups at end of treatment (T2) as measured by the ITQ and CAPS-5.

  September 2023- September 2025

Secondary Outcomes (1)

• substance use severity

  September 2023- September 2025

Other Outcomes (2)

• (Serious) adverse events

  September 2023- September 2025

• EMDR treatment adherence

  September 2023- September 2025

Study Arms (2)

Addiction and PTSD

Behavioral: Eye movement desensitization and reprocessing (EMDR); Behavioral: CRA

Addiction and CPTSD

Behavioral: Eye movement desensitization and reprocessing (EMDR); Behavioral: CRA

Interventions

Eye movement desensitization and reprocessing (EMDR) BEHAVIORAL

Integrated addiction and traumafocused treatment.

Addiction and CPTSD; Addiction and PTSD

CRA BEHAVIORAL

CRA is a comprehensive cognitive behavioural treatment that focuses on helping people discover and adopt a pleasurable, social and healthy lifestyle that is more rewarding than a lifestyle including substance use.

Addiction and CPTSD; Addiction and PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 50 eligible patients are enrolled from an outpatient treatment site of IrisZorg, a Dutch care provider for addiction care and sheltered housing. Patients will be screened at intake for addiction treatment. An additional screening can be performed during addiction treatment when symptoms of PTSD are suspected.

You may qualify if:

• Age ≥18 years. •- Primary diagnosis SUD involving one of the following substances: alcohol, cannabis, cocaine, amphetamine, benzodiazepine, opioid according to the DSM-5 (American Psychiatric Association, 2013), who are receiving or starting outpatient CRA.
• A DSM-5 diagnosis of PTSD (n=25). A DSM-5 diagnosis of PTSD and an additional ICD-11 diagnosis of CPTSD (n=25).
• Planned start of EMDR-therapy within 8 weeks.
• Good Dutch language proficiency (based on clinical judgement).
• Written informed consent

Sponsors & Collaborators

• IrisZorg: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

IrisZorg

Arnhem, Netherlands

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Behavior, Addictive

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Angelique Dekkers, MSc.

CONTACT

+31-886061463; angelique.dekkers@iriszorg.nl

Wiebren Markus, PhD

CONTACT

0031-88-6061396; w.markus@iriszorg.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)