Posttraumatic Stress DisorderSTABNCT02450617
Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial
A study testing Conventional individual treatment, Stabilizing group treatment for PTSD and Stabilizing group treatment for Dissociative disorders in people with Posttraumatic Stress Disorder and Dissociative Identity Disorder, run by Modum Bad at 1 site in Norway.
Trial summary
The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Dissociative Identity Disorder, Dissociative Disorder
- What is being tested?
- Conventional individual treatment, Stabilizing group treatment for PTSD and Stabilizing group treatment for Dissociative disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Sep 2019
- 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
None listed.
Who cannot join
- Acute suicidality
- Serious substance abuse interfering with treatment
- Serious psychotic symptoms
- Current life - crisis interfering with therapy (e.g. ongoing abuse, divorce, court case, somatic disease in spouse or children, etc.)
- Neurological disease, mental disability or life threatening somatic disease. For the PTSD arm of the study an additional exclusion criteria will be that the patient meets the criteria for a dissociative disorder.
Trial locations and contacts
1 site in 1 country.
About this study
The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The investigators also aim to study psychophysiological markers associated with complex trauma and treatment, mechanisms of change involved in treatment, and which patient characteristics that predict positive outcome.
Read the detailed description
Patients with histories of repeated traumatization in childhood often display a wide array of symptoms described as complex traumatic stress disorder. This sequela involves a high degree of comorbid mental and somatic disturbances, and entails tremendous health care costs for society and suffering for the victims. Despite the prevalence and consequences of complex trauma, research on effective treatments is extremely limited. Expert clinicians suggest that initial treatment for these patients should focus on stabilization of symptoms through psychoeducation and skills - training, and some research has supported this advice. Offering such treatment as group therapy can be both cost - effective and give patients additional peer-support. The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with PTSD or dissociative disorders after childhood abuse. This will be investigated in a randomized controlled design. The investigators also aim to discover psychophysiological markers associated with treatment, mechanisms of change involved in treatment, and what patient characteristics that predict outcome. The results may contribute to new knowledge about treatment of complex traumatization, as well as new and improved health services for a vulnerable patient group with little specialized treatment today.
The main aim of this project is to compare the effectiveness of stabilizing group treatment as an add-on to conventional individual therapy, to conventional individual therapy alone, in a randomized controlled design. This will be tested in two independent diagnostic groups: Patients with PTSD and patients with Dissociative disorders, both groups with reports of childhood abuse. The investigators will further investigate how level of dissociative symptoms influence treatment, how group climate influence symptoms, the relationship between individual and group therapy in combined treatment, and how treatment affects Heart Rate Variability. The investigators also seek to evaluate the treatment economically with a societal perspective, carrying out cost-utility analyses.
- Being tested
- Conventional individual treatment, Stabilizing group treatment for PTSD, Stabilizing group treatment for Dissociative disorders
- Keywords
- Complex PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Dissociative Identity Disorder, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional individual treatmentBehavioural
Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist
Stabilizing group treatment for PTSDBehavioural
Also called "Back to here and now"
20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.
Stabilizing group treatment for Dissociative disordersBehavioural
Also called "Coping with Trauma-Related Dissociation"
20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training
| Study group | Role | What they receive |
|---|---|---|
| Stabilizing group treatment for PTSD | Experimental | Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. Receives: Behavioral: Conventional individual treatment; Behavioral: Stabilizing group treatment for PTSD |
| Conventional Individual treatment - PTSD | Active comparator | Conventional individual treatment. Receives: Behavioral: Conventional individual treatment |
| Stabilizing group treatment for Dissociative disorders | Experimental | Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. Receives: Behavioral: Conventional individual treatment; Behavioral: Stabilizing group treatment for Dissociative disorders |
| Conventional Individual treatment - Dissociative disorders | Active comparator | Conventional individual treatment. Receives: Behavioral: Conventional individual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Functioning - change from baseline
Daily life functioning and severity of symptoms last week, assessed by interview
Measured: 1 week after completed treatment
Global Assessment of Functioning- change from baseline
Daily life functioning and severity of symptoms last week, assessed by interview
Measured: 6 months after completed treatment
Secondary outcomes (14)
Heart rate variability- change from baseline
Resting state heart rate variability
Measured: 1 week after completed treatment
Heart rate variability - change from baseline
Resting state heart rate variability
Measured: 6 months after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Measured: 1 week after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Measured: 6 months after completed treatment
Symptom Checklist 90 Revised - change from baseline
Measured: 1 week after completed treatment
Symptom Checklist 90 Revised - change from baseline
Measured: 6 months after completed treatment
Inventory of Interpersonal Problems - change from baseline
Measured: 1 week after completed treatment
Inventory of Interpersonal Problems - change from baseline
Measured: 6 months after completed treatment
Dissociative Experiences Scale II - change from baseline
Measured: 1 week after completed treatment
Dissociative Experiences Scale II - change from baseline
Measured: 6 months after completed treatment
Behavior Checklist - change from baseline
registers function and self-destructive behavior
Measured: 1 week after completed treatment
Behavior Checklist - change from baseline
registers function and self-destructive behavior
Measured: 6 months after completed treatment
Short Form 36 - change from baseline
Measured: 1 week after completed treatment
Short Form 36 - change from baseline
Measured: 6 months after completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2019
- Study completionSep 2019
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 Posttraumatic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 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
- NCT02450617
- Sponsor's protocol ID
- Oslo
- Acronym
- STAB
- Status last verified
- Sep 2019
- First submitted
- 13 May 2015
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Baekkelund H, Ulvenes P, Boon-Langelaan S, Arnevik EA. Group treatment for complex dissociative disorders: a randomized clinical trial. BMC Psychiatry. 2022 May 16;22(1):338. doi: 10.1186/s12888-022-03970-8.
PubMed 35578194
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02450617
- Acronym / sponsor ID
- STAB / Oslo
- Keywords
- Complex PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 21 May 2015 (estimated)
- 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.
The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The investigators also aim to study psychophysiological markers associated with complex trauma and treatment, mechanisms of change involved in treatment, and which patient characteristics that predict positive outcome.
Detailed description
Patients with histories of repeated traumatization in childhood often display a wide array of symptoms described as complex traumatic stress disorder. This sequela involves a high degree of comorbid mental and somatic disturbances, and entails tremendous health care costs for society and suffering for the victims. Despite the prevalence and consequences of complex trauma, research on effective treatments is extremely limited. Expert clinicians suggest that initial treatment for these patients should focus on stabilization of symptoms through psychoeducation and skills - training, and some research has supported this advice. Offering such treatment as group therapy can be both cost - effective and give patients additional peer-support. The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with PTSD or dissociative disorders after childhood abuse. This will be investigated in a randomized controlled design. The investigators also aim to discover psychophysiological markers associated with treatment, mechanisms of change involved in treatment, and what patient characteristics that predict outcome. The results may contribute to new knowledge about treatment of complex traumatization, as well as new and improved health services for a vulnerable patient group with little specialized treatment today.
The main aim of this project is to compare the effectiveness of stabilizing group treatment as an add-on to conventional individual therapy, to conventional individual therapy alone, in a randomized controlled design. This will be tested in two independent diagnostic groups: Patients with PTSD and patients with Dissociative disorders, both groups with reports of childhood abuse. The investigators will further investigate how level of dissociative symptoms influence treatment, how group climate influence symptoms, the relationship between individual and group therapy in combined treatment, and how treatment affects Heart Rate Variability. The investigators also seek to evaluate the treatment economically with a societal perspective, carrying out cost-utility analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stabilizing group treatment for PTSD | Experimental | Behavioral: Conventional individual treatment, Behavioral: Stabilizing group treatment for PTSDGroup treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. |
| Conventional Individual treatment - PTSD | Active comparator | Behavioral: Conventional individual treatmentConventional individual treatment. |
| Stabilizing group treatment for Dissociative disorders | Experimental | Behavioral: Conventional individual treatment, Behavioral: Stabilizing group treatment for Dissociative disordersGroup treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. |
| Conventional Individual treatment - Dissociative disorders | Active comparator | Behavioral: Conventional individual treatmentConventional individual treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Acute suicidality
- Serious substance abuse interfering with treatment
- Serious psychotic symptoms
- Current life - crisis interfering with therapy (e.g. ongoing abuse, divorce, court case, somatic disease in spouse or children, etc.)
- Neurological disease, mental disability or life threatening somatic disease. For the PTSD arm of the study an additional exclusion criteria will be that the patient meets the criteria for a dissociative disorder.
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 |
|---|---|---|
| Conventional individual treatmentIndividual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist | Behavioural | Conventional Individual treatment - Dissociative disorders, Conventional Individual treatment - PTSD, Stabilizing group treatment for Dissociative disorders, Stabilizing group treatment for PTSD |
| Stabilizing group treatment for PTSDAlso: "Back to here and now"20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training. | Behavioural | Stabilizing group treatment for PTSD |
| Stabilizing group treatment for Dissociative disordersAlso: "Coping with Trauma-Related Dissociation"20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training | Behavioural | Stabilizing group treatment for Dissociative disorders |
Primary outcome
Global Assessment of Functioning - change from baseline
Time frame: 1 week after completed treatment
Daily life functioning and severity of symptoms last week, assessed by interview
Global Assessment of Functioning- change from baseline
Time frame: 6 months after completed treatment
Daily life functioning and severity of symptoms last week, assessed by interview
14 secondary outcomes
Heart rate variability- change from baseline
Time frame: 1 week after completed treatment
Heart rate variability - change from baseline
Time frame: 6 months after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Time frame: 1 week after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Time frame: 6 months after completed treatment
Symptom Checklist 90 Revised - change from baseline
Time frame: 1 week after completed treatment
Symptom Checklist 90 Revised - change from baseline
Time frame: 6 months after completed treatment
Inventory of Interpersonal Problems - change from baseline
Time frame: 1 week after completed treatment
Inventory of Interpersonal Problems - change from baseline
Time frame: 6 months after completed treatment
Dissociative Experiences Scale II - change from baseline
Time frame: 1 week after completed treatment
Dissociative Experiences Scale II - change from baseline
Time frame: 6 months after completed treatment
Behavior Checklist - change from baseline
Time frame: 1 week after completed treatment
Behavior Checklist - change from baseline
Time frame: 6 months after completed treatment
Short Form 36 - change from baseline
Time frame: 1 week after completed treatment
Short Form 36 - change from baseline
Time frame: 6 months after completed treatment
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 27 Sep 2019.
- Derived from this study: PubMed 35578194Baekkelund H, Ulvenes P, Boon-Langelaan S, Arnevik EA. Group treatment for complex dissociative disorders: a randomized clinical trial. BMC Psychiatry. 2022 May 16;22(1):338. doi: 10.1186/s12888-022-03970-8.
Related trials for Posttraumatic Stress Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
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 Conventional individual treatment, Stabilizing group treatment for PTSD and Stabilizing group treatment for Dissociative disorders in people with Posttraumatic Stress Disorder and Dissociative Identity 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 0 inclusion and 5 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 27 Sep 2019. 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?
Global Assessment of Functioning - change from baseline (time frame: 1 week after completed treatment). 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?
On the ClinicalTrials.gov record for NCT02450617, 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 27 Sep 2019.