Post-Traumatic Stress DisorderNCT03509844
The Modum Bad Complex Posttraumatic Stress Disorder Study
A study testing Psychotherapy in people with Post-Traumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
Trial summary
This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- 20 Sep 2017to 30 Oct 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- childhood trauma (e.g. sexual abuse, violence prior to age 18),
- a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5
- a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11)
Who cannot join
- severe psychotic disorder
- dissociative identity disorder (DID)
- active phase substance dependence
- acute suicidality
- major current life crisis
- severely disturbed group functioning
- mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.
Read the detailed description
Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings.
96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure | Experimental | Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting Receives: Behavioral: Psychotherapy |
| STAIR | Experimental | Psychotherapy: 10 weeks, Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting Receives: Behavioral: Psychotherapy |
| STAIR/NT | Experimental | Psychotherapy: 16 weeks, 10 weeks Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), followed by 6 weeks of Narrative Therapy (NT) (individual sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting. Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
30 items structured interview corresponding to the definition of PTSD in DSM-5. 20 items correspond to the symptoms for PTSD and are scored on a 0-4 severity scale to establish symptom severity (range 0-40)
Measured: approximately 15 months
Secondary outcomes (3)
The PTSD Checklist for DSM-5 (PCL-5)
20 items self-report measure for PTSD symptoms corresponding to DSM-5 criteria for PTSD. Severity is scored on a 0-4 scale (range 0-40)
Measured: approximately 15 months
Inventory of Interpersonal Problems (IIP-64)
64 items self-report measure for interpersonal problems. Severity is scored on a 0-4 scale (range 0-256)
Measured: approximately 15 months
Beck Depression Inventory-Second Edition (BDI-II)
21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63
Measured: approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start20 Sep 2017
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509844
- Sponsor's protocol ID
- CPTSD-Peter_Sele
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2018
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sele P, Hoffart A, Cloitre M, Hembree E, Oktedalen T. Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial. J Anxiety Disord. 2023 Dec;100:102786. doi: 10.1016/j.janxdis.2023.102786. Epub 2023 Oct 12.
PubMed 37871452
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03509844
- Acronym / sponsor ID
- CPTSD-Peter_Sele
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 26 Apr 2018 (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.
This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.
Detailed description
Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings.
96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Experimental | Behavioral: PsychotherapyPsychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting |
| STAIR | Experimental | Behavioral: PsychotherapyPsychotherapy: 10 weeks, Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting |
| STAIR/NT | Experimental | Behavioral: PsychotherapyPsychotherapy: 16 weeks, 10 weeks Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), followed by 6 weeks of Narrative Therapy (NT) (individual sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- childhood trauma (e.g. sexual abuse, violence prior to age 18),
- a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5
- a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11)
Key exclusion criteria (7 listed)
- severe psychotic disorder
- dissociative identity disorder (DID)
- active phase substance dependence
- acute suicidality
- major current life crisis
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 |
|---|---|---|
| PsychotherapyThree established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions. | Behavioural | Prolonged Exposure, STAIR, STAIR/NT |
Primary outcome
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Time frame: approximately 15 months
30 items structured interview corresponding to the definition of PTSD in DSM-5. 20 items correspond to the symptoms for PTSD and are scored on a 0-4 severity scale to establish symptom severity (range 0-40)
3 secondary outcomes
The PTSD Checklist for DSM-5 (PCL-5)
Time frame: approximately 15 months
Inventory of Interpersonal Problems (IIP-64)
Time frame: approximately 15 months
Beck Depression Inventory-Second Edition (BDI-II)
Time frame: approximately 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 37871452Sele P, Hoffart A, Cloitre M, Hembree E, Oktedalen T. Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial. J Anxiety Disord. 2023 Dec;100:102786. doi: 10.1016/j.janxdis.2023.102786. Epub 2023 Oct 12.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Post-Traumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (time frame: approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509844, which also lists 1 linked publication.
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 30 Mar 2023.