PTSDNCT06588309
The Course and Outcome of Integreated Trauma and Addiction Treatment Between PTSD and CPTSD
An observational study of PTSD and Addiction, run by IrisZorg at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Eye movement desensitization and reprocessing (EMDR) and CRA
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
IrisZorg
Arnhem
Angelique Dekkers, MSc, 0031-88-6061600, angelique.dekkers@iriszorg.nl
Teun Meijer, MSc, 0031-88-6061600, t.meijer1@iriszorg.nl
About this study
Official title: What's in a Name? Do PTSD and Complex PTSD Diagnoses Predict Differences in Course and Outcome of Integrated Addiction and Trauma Focused Treatment?
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.
Read the detailed description
Rationale: 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.
Objective: To determine differences in course and outcome of integrated trauma-focused treatment delivered alongside addiction treatment in participants with comorbid PTSD and CPTSD.
Study design: An observational, prospective study with two groups (N = 50, allocation ratio 1:1) of participants with a SUD. One group has a comorbid PTSD (n = 25) and the other a comorbid CPTSD (n = 25). Assessments take place at baseline (T0), after every trauma- focused treatment session (T11-9) and after 10 weeks during which trauma-focused treatment may or may not have been completed or prematurely terminated (T2).
Study population: Patients with SUD and either comorbid PTSD or CPTSD, aged ≥ 18 years, with good Dutch language proficiency, who receive addiction treatment and trauma-focused treatment and who provide written informed consent.
Intervention: Treatment as usual (TAU), in accordance with the Dutch clinical practice guidelines consists of 1) addiction treatment according to the Community Reinforcement Approach (henceforth CRA) and 2) trauma-focused treatment (EMDR-therapy, henceforth EMDR).
Main study parameters/endpoints: Changes in PTSD symptom severity in participants with comorbid PTSD and CPTSD from T0 to T2, as measured by the PCL-5 and CAPS-5.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants receive TAU, both CRA and EMDR, including standardized assessments. Additionally, participants fill in one extra questionnaire (ITQ) at T0 and T2 and the CAPS is administered additionally at T2. The extra burden of filling the ITQ is approximately one minute and for the CAPS approximately ten to forty-five minutes depending on the amount of symptoms after trauma treatment. Given the observational nature of the study, no risks related to the study are expected beyond those associated with routine clinical addiction care (e.g. relapse).
To optimize data-collection, especially after termination of EMDR before T2 assessment, participants receive an incentive, a voucher worth 10 euro, after completing the baseline (T0) assessment and the first five PCL-5 assessments (T11-5), and a voucher worth 15 euro after completing the next four PCL-5 assessments (T16-9) and the final assessment (T2).
- Being tested
- Eye movement desensitization and reprocessing (EMDR), CRA
- Keywords
- PTSD, CPTSD, Addiction, EMDR, CRA
- Medical subject headings
- Stress Disorders, Post-Traumatic, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye movement desensitization and reprocessing (EMDR)Behavioural
Integrated addiction and traumafocused treatment.
CRABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Addiction and PTSD | Not described Receives: Behavioral: Eye movement desensitization and reprocessing (EMDR); Behavioral: CRA | |
| Addiction and CPTSD | Not described Receives: Behavioral: Eye movement desensitization and reprocessing (EMDR); Behavioral: CRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: September 2023- September 2025
Secondary outcomes (1)
substance use severity
- Changes in substance use between participants with comorbid PTSD and CPTSD from T0 to T2, as measured by the MATE, section one
Measured: September 2023- September 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IrisZorg
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588309
- Sponsor's protocol ID
- CPTSS
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What's in a Name? Do PTSD and Complex PTSD Diagnoses Predict Differences in Course and Outcome of Integrated Addiction and Trauma Focused Treatment?
- ClinicalTrials.gov ID
- NCT06588309
- Acronym / sponsor ID
- CPTSS
- Keywords
- PTSD, CPTSD, Addiction, EMDR, CRA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IrisZorgUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: 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.
Objective: To determine differences in course and outcome of integrated trauma-focused treatment delivered alongside addiction treatment in participants with comorbid PTSD and CPTSD.
Study design: An observational, prospective study with two groups (N = 50, allocation ratio 1:1) of participants with a SUD. One group has a comorbid PTSD (n = 25) and the other a comorbid CPTSD (n = 25). Assessments take place at baseline (T0), after every trauma- focused treatment session (T11-9) and after 10 weeks during which trauma-focused treatment may or may not have been completed or prematurely terminated (T2).
Study population: Patients with SUD and either comorbid PTSD or CPTSD, aged ≥ 18 years, with good Dutch language proficiency, who receive addiction treatment and trauma-focused treatment and who provide written informed consent.
Intervention: Treatment as usual (TAU), in accordance with the Dutch clinical practice guidelines consists of 1) addiction treatment according to the Community Reinforcement Approach (henceforth CRA) and 2) trauma-focused treatment (EMDR-therapy, henceforth EMDR).
Main study parameters/endpoints: Changes in PTSD symptom severity in participants with comorbid PTSD and CPTSD from T0 to T2, as measured by the PCL-5 and CAPS-5.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants receive TAU, both CRA and EMDR, including standardized assessments. Additionally, participants fill in one extra questionnaire (ITQ) at T0 and T2 and the CAPS is administered additionally at T2. The extra burden of filling the ITQ is approximately one minute and for the CAPS approximately ten to forty-five minutes depending on the amount of symptoms after trauma treatment. Given the observational nature of the study, no risks related to the study are expected beyond those associated with routine clinical addiction care (e.g. relapse).
To optimize data-collection, especially after termination of EMDR before T2 assessment, participants receive an incentive, a voucher worth 10 euro, after completing the baseline (T0) assessment and the first five PCL-5 assessments (T11-5), and a voucher worth 15 euro after completing the next four PCL-5 assessments (T16-9) and the final assessment (T2).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addiction and PTSD | – | Behavioral: Eye movement desensitization and reprocessing (EMDR), Behavioral: CRA |
| Addiction and CPTSD | – | Behavioral: Eye movement desensitization and reprocessing (EMDR), Behavioral: CRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye movement desensitization and reprocessing (EMDR)Integrated addiction and traumafocused treatment. | Behavioural | Addiction and CPTSD, Addiction and PTSD |
| CRACRA 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. | Behavioural | Addiction and CPTSD, Addiction and PTSD |
Primary outcome
PTSD symptom severity
Time frame: September 2023- September 2025
Changes over time in PTSD symptom severity between participants with comorbid PTSD and CPTSD from T0-T2 as measured by the PCL-5.
Proportion of lost of the (C)PTSD diagnosis
Time frame: September 2023- September 2025
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.
1 secondary outcome
substance use severity
Time frame: September 2023- September 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Addiction, run by IrisZorg at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelique Dekkers, MSc. (+31-886061463, angelique.dekkers@iriszorg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity (time frame: September 2023- September 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.