Modum Bad, Out patient Trauma clinic
Oslo, 0251, Norway
NCT Number: NCT07677046
The goal of this pilot clinical trial is to learn whether an integrated 16-week treatment program can be helpful, acceptable, and feasible for adults with complex dissociative disorder (CDD). The program combines individual Deep Brain Reorienting (DBR) therapy with a supportive therapeutic group.
The study is conducted at an outpatient clinic for traume-related disorders in Oslo, Norway, and enrols individuals based on rights to receive specialist treatment in the Norwegian public health system.
The main questions it aims to answer are:
Is it possible to recruit, retain, and treat patients with CDD in this program (feasibility, attendance, drop-out, and treatment tolerability)? How do participants experience receiving DBR together with a supportive group (helpfulness, burden, and suggestions for improvement)? Are there preliminary changes in symptoms, functioning, and quality of life from before to after treatment and at 6-month follow-up? Are two new DBR-specific questionnaires (Where Self Awareness Scale and Shock Induced Vigilance Scale) useful for this patient group? There is no comparison group in this pilot study. All participants receive the same integrated DBR + group intervention.
Participants will:
* Take part in two preparatory individual sessions to receive information about DBR, try the method, and clarify treatment goals. * Attend a 16-week program with one 45-minute individual DBR session per week and two 30-minute online group sessions per week. * Join in-person group meetings before the program and a focus group meeting at the end to talk about what was helpful and what could be improved. * Complete standard questionnaires about trauma-related symptoms before and after treatment, as well as two brief DBR-specific questionnaires at several time points. * Take part in group interviews right after treatment and 6 months later, and have an individual closing session to summarize their experiences and discuss next steps.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Oslo, 0251, Norway
Integrating Individual Deep Brain Reorienting with a Supportive Group Intervention for Complex Dissociative Disorders:
A 16-Week Feasibility and Pilot Study
For PTSD in general, trauma-focused exposure treatment is recommended as first choise (NICE guidelines). There is increasing evidence that such approaches may also be useful in more complex traumatization (Oprel et al., 2021; Raabe et al., 2022; Sele et al., 2023; van Vliet et al., 2021), while some studies suggest that patients with particularly high levels of dysregulation often need a more phase-oriented approach (e.g., Bohus et al., 2020). For complex dissociative disorders, there are currently only two randomized controlled trials (RCTs) that specifically target this patient group. In Brand et al. (2025), a psychoeducational skills training program ("Finding Solid Ground") as the first phase of treatment showed a significant effect over and above usual individual therapy. In another RCT, where a 20-week psychoeducational group intervention was compared with standard individual therapy, both groups showed improved functioning, but there was no additional effect of the group and no clear symptom reduction (Bækkelund et al., 2022). There are no RCTs testing the effect of trauma-focused exposure treatment for individuals with CDD.
International guidelines (ISSTD, 2011; Brand et al., 2012) recommend a phase-oriented approach to treatment of CDD. In phase 1, work focuses on stabilization and skills training before progressing to more direct trauma processing. A central clinical dilemma is that these treatment courses often become very long, and many patients never reach phase 2, where the traumatic memories themselves are processed. The field lacks methods that can safely address the core of the trauma before patients have built substantial capacity through long-term stabilization work.
Deep Brain Reorienting (DBR) is a relatively new, transdiagnostic trauma treatment based on neuropsychological and neurobiological research (Corrigan et al., 2024). The method aims to access and process traumatic experiences by following the original sequence of physiological responses that occurred when the midbrain was alerted to a threat or relational injury that exceeded the person's integrative capacity. DBR focuses on processing the "shock" in subcortical, pre-verbal systems, and targets the orienting response and the subsequent fear sequence (Corrigan et al., 2024). Rather than working directly with trauma memories, DBR can address current trigger situations and process underlying shock responses without necessarily activating the most overwhelming feelings and memories.
A randomized controlled study (Kearney et al., 2023) of eight web-based DBR sessions compared with a waitlist condition found substantial reductions in PTSD symptoms immediately after treatment and at three-month follow-up. The active treatment group had nearly 50% symptom reduction, and many participants no longer met criteria for PTSD. The results suggest that DBR may be as effective as established trauma treatments, while appearing more tolerable and having a lower dropout rate. Further research, including fMRI studies conducted by the research group around Lanius and adaptations for more complex patient groups, is underway (e.g., Corrigan et al., 2024; Gerge, 2025).
The field has so far not identified methods that can safely address the traumatic events and the causes of dissociative symptoms early in treatment, before patients have built significant capacity through extended stabilization work. For some patients this can take a very long time, and some never reach genuine trauma processing. DBR appears to be a promising approach for working with the "imprint" of trauma without necessarily having to activate the trauma memories themselves, and may potentially enable earlier processing than what has been common so far. This constitutes the background for the present study.
The aim of this study is to carry out a feasibility/pilot study of a 16-week integrated treatment program for patients with complex dissociative disorders, in which individual DBR is combined with a supportive group intervention. More specifically, we aim to:
In the longer term, the project may contribute to developing a more targeted treatment offering for a patient group that currently has a large unmet need, and provide a basis for a subsequent, larger controlled study.
The intervention is delivered on an outpatient basis at the Trauma Outpatient Clinic and includes:
We therefore use a mixed-methods approach:
Such a sample is too small to provide sufficient statistical power to draw firm conclusions about effectiveness, but is considered sufficient to:
The study is thus explicitly designed as a feasibility/pilot study.
Recruitment Patients referred to the Trauma Outpatient Clinic at Modum Bad in Oslo are assessed according to the clinic's standard procedures. As part of this assessment, the most suitable treatment offering at the clinic is considered. Patients who appear to be a good fit for the DBR program are informed about the study verbally and in writing, and invited to an assessment session where the study is reviewed in more detail.
The quantitative pre-post measures will be analysed descriptively and with simple statistical analyses to explore possible trends in change in symptoms, functioning, and quality of life, and to assess the usefulness of the DBR-specific questionnaires (Where Self Awareness Scale and Shock Induced Vigilance Scale) as outcome and process measures.
Given the small sample, the analyses will be exploratory and hypothesis-generating, not conclusive.
Possible disadvantages/burdens
Measures to reduce risk and burden
Overall, the burden of participation is considered moderate and within what is usual for treatment at the Trauma Outpatient Clinic. The potential benefits for individual patients, the patient group, and society are considered substantial.
Previous clinical experience with DBR suggests that the method is well tolerated and perceived as helpful. These experiences have informed the planning of the study. The project staff assess that most participants will find it meaningful to provide feedback on their treatment and contribute to the development of the field.
The benefits of the study (the possibility of improved treatment offerings for a highly vulnerable patient group, and knowledge development in an area with substantial knowledge gaps) are judged to outweigh the risks of burden associated with participation. Given the established measures to protect participants, the project is considered ethically justifiable.
Both the project responsible and the project staff member have additional training in body-oriented trauma treatment (Sensorimotor Psychotherapy), EMDR, Narrative Exposure Therapy, and DBR, and more than 20 years of clinical experience with this patient group.
The Trauma Outpatient Clinic aims to be innovative and contribute to the development of more effective treatment methods. The clinic leader supports the project. Modum Bad has its own research department with available resources that has been involved from the project planning phase.
User involvement is ensured by systematically collecting patients' experiences through focus group interviews and using these to improve the treatment model.
Frank Corrigan (psychiatrist, developer of DBR) has contributed input on the study design and provided relevant DBR-specific questionnaires. He will provide clinical supervision to the therapists to ensure good treatment integrity.
There are no restrictions on publication. The results will:
All dissemination will be at an aggregated level and in a form that makes it impossible to identify individual participants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive 1-3 preparatory individual sessions for assessment, psychoeducation about Deep Brain Reorienting (DBR), and demonstration of the method, followed by 16 weekly individual DBR sessions (45 minutes each) delivered by DBR-trained therapists. DBR is a trauma-focused psychotherapy that targets the orienting and shock responses linked to threatening or attachment-related experiences, using present-moment orienting as an anchor to process subcortical shock responses without necessarily activating full trauma memories.
Other names: DBR
Participants attend two initial in-person group sessions providing psychoeducation about DBR, introduction and practice of the "Where Self" orienting exercise, and establishment of a safe group climate. During the 16-week program, participants attend two brief digital group meetings per week: one to identify a focus or trigger for the upcoming individual DBR session and practice "Where Self", and one to further adapt "Where Self" and reflect on experiences and new perspectives from DBR processing. After the 16-week program and at 6-month follow-up, participants also attend focus group interviews to discuss their experiences of the combined DBR and group intervention.
Other names: Group support
Time frame: From study start to end of 16-week treatment program (approximately 6-9 months, depending on recruitment period)
Feasibility will be evaluated by:
recruitment rate (number of eligible patients enrolled / number of eligible patients approached), proportion of participants initiating treatment, and retention rate (number and percentage of participants completing the 16-week program).
These indicators will be extracted from clinic and study records.
Time frame: Post-treatment (immediately after the 16-week program)
Acceptability and tolerability will be assessed with qualitative data from post-treatment focus group interviews (thematic analysis of perceived benefits, burdens, and suggestions for improvement).
Time frame: Baseline (pre-treatment), post-treatment (16 weeks), and 6-month follow-up
PTSD symptoms will be measured with the PTSD Checklist for DSM-5 (PCL-5). Total score change from baseline to post-treatment and 6-month follow-up will be used to explore preliminary effects on trauma-related symptoms.
Time frame: Baseline, post-treatment (16 weeks), and 6-month follow-up
Dissociative symptoms will be measured with the Dissociative Experiences Scale (DES). Changes in DES total score from baseline to post-treatment and 6-month follow-up will be examined.
Time frame: Baseline, post-treatment (16 weeks), and 6-month follow-up
General psychological distress and functioning will be measured with the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Change in overall mean score will be examined as an indicator of broad clinical change.
Time frame: Baseline, during treatment (e.g., weekly or at predefined intervals), post-treatment, and 6-month follow-up
The Where Self Awareness Scale is a DBR-specific measure assessing orienting and self-awareness related to shock and threat responses. It will be used both as a process measure (patterns of change during treatment) and as an outcome measure (pre- to post-treatment and follow-up). The study will explore feasibility of use, score distributions, and sensitivity to change in this CDD sample.
Time frame: Baseline, during treatment (e.g., weekly or at predefined intervals), post-treatment, and 6-month follow-up
The Shock Induced Vigilance Scale is a DBR-specific measure assessing vigilance and activation related to shock responses. It will be used primarily as a process measure, with repeated assessments over the 16-week program, and secondarily as an outcome measure (pre- to post-treatment and follow-up). The study will evaluate feasibility, interpretability, and preliminary sensitivity to change.
Modum Bad
Other
Integrating Individual Deep Brain Reorienting With a Supportive Group Intervention for Complex Dissociative Disorders: A 16-Week Feasibility and Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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