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临床试验/NCT07677046
NCT07677046Enrolling By Invitation不适用

Integrating Individual Deep Brain Reorienting With a Supportive Group Intervention for Complex Dissociative Disorders: A 16-Week Feasibility and Pilot Study

Modum Bad1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Modum Bad
入组人数
10
试验地点
1
主要终点
Feasibility of recruitment, retention and attendance

研究概览

简要总结

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.

详细描述

Integrating Individual Deep Brain Reorienting with a Supportive Group Intervention for Complex Dissociative Disorders:

A 16-Week Feasibility and Pilot Study

  1. Background and current state of knowledge Complex dissociative disorders (CDD), including dissociative identity disorder (DID) and other specified dissociative disorders (OSDD), are severe conditions that often develop as a consequence of early, repeated, and overwhelming traumatic events. Patients frequently present with extensive dissociative symptoms such as amnesia and identity confusion, emotional dysregulation, relational difficulties, and marked functional impairment. Despite high levels of burden for both patients and health services, there is very limited research-based knowledge about effective treatment for this group.

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Feasibility of recruitment, retention and attendance

时间窗: 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.

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

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Modum Bad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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