NCT07677046

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
May 2026Jun 2027

Study Start

First participant enrolled

May 4, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 24, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

Deep Brain ReorientingCombined DBR and group

Outcome Measures

Primary Outcomes (2)

  • Feasibility of recruitment, retention and attendance

    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.

    From study start to end of 16-week treatment program (approximately 6-9 months, depending on recruitment period)

  • Participant-reported acceptability and tolerability of the integrated DBR and group intervention

    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).

    Post-treatment (immediately after the 16-week program)

Secondary Outcomes (5)

  • Change in PTSD symptoms (PCL-5)

    Baseline (pre-treatment), post-treatment (16 weeks), and 6-month follow-up

  • Change in dissociative symptoms (DES)

    Baseline, post-treatment (16 weeks), and 6-month follow-up

  • Change in general psychological distress and functioning (CORE-OM)

    Baseline, post-treatment (16 weeks), and 6-month follow-up

  • Change in orienting and self-awareness (Where Self Awareness Scale)

    Baseline, during treatment (e.g., weekly or at predefined intervals), post-treatment, and 6-month follow-up

  • Change in shock-related vigilance (Shock Induced Vigilance Scale)

    Baseline, during treatment (e.g., weekly or at predefined intervals), post-treatment, and 6-month follow-up

Study Arms (1)

Integrated DBR plus Supportive Group Intervention

EXPERIMENTAL

Participants receive a 16-week integrated treatment program combining individual Deep Brain Reorienting (DBR) with a supportive group intervention. The program includes 1-3 preparatory individual sessions, two initial in-person psychoeducational group meetings, 16 weekly individual DBR sessions (45 minutes), and two brief digital group meetings per week focused on orienting practice ("Where Self") and integration of DBR experiences. After treatment, participants attend a focus group interview and complete follow-up assessments at post-treatment and 6 months.

Behavioral: Individual Deep Brain Reorienting (DBR)Behavioral: Supportive Group Intervention with "Where Self" Training

Interventions

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.

Also known as: DBR
Integrated DBR plus Supportive Group Intervention

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.

Also known as: Group support
Integrated DBR plus Supportive Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Meets criteria for complex dissociative disorder (DID or OSDD; e.g. F44.88/F44.81)
  • Referred to the Trauma Outpatient Clinic
  • Own motivation to participate in the DBR intervention and the associated group program

You may not qualify if:

  • Ongoing severe substance abuse
  • Violent behavior
  • Severe current crisis
  • Ongoing high risk of suicide
  • Psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modum Bad, Out patient Trauma clinic

Oslo, Oslo, 0251, Norway

Location

MeSH Terms

Conditions

Dissociative Identity Disorder

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Dissociative DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • KariAnne Vrabel, Professor

    Modum Bad; Reseach Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group assignment feasibility/pilot trial. All participants are allocated to one experimental arm receiving an integrated 16-week treatment program combining individual Deep Brain Reorienting (DBR) with a supportive group intervention. The study is designed to evaluate feasibility, acceptability, and preliminary clinical changes (symptoms, functioning, quality of life), and to test two DBR-specific measures (Where Self Awareness Scale, Shock Induced Vigilance Scale). There is no control or comparison group; all enrolled participants receive the same intervention according to a standardized protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Data sharing is not planned and is regulated by the the ethics approval from The Regional Committees for Medical and Health Research Ethics (REK). Anonymized data will be made available upon reasonable request.

Locations