跳至主要内容
临床试验/NCT06894264
NCT06894264尚未招募不适用

Emotion Processing and Regulation in People With Intellectual Disability

Karolinska Institutet0 个研究点目标入组 40 人开始时间: 2026年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Difficulties in emotion regulation scale (DERS-SF)

研究概览

简要总结

BACKGROUND

Intellectual disability (ID) is neurodevelopmental disorder with social impairments, in areas such as interpersonal communication skills and emotion regulation. This overlaps with disabilities associated with autism spectrum disorder (ASD). Differences in emotion processing, specifically emotion recognition, reappraisal, and reinforcement learning, has not been compared between patients with ID and ASD. Despite difficulties in emotion regulation among patients with ID, there is a lack of adapted psychotherapy for this patient group.

AIMS

  • To examine differences in emotion processing in individuals with intellectual disability (ID) compared to individuals with autism spectrum disorder (ASD) and typically developed individuals.
  • To evaluate the feasibility and effectiveness of an adapted psychotherapeutic intervention to improve emotion regulation in individuals with ID.

Data and method

The first research question is addressed through a cross-sectional study involving 160 participants: 40 individuals with ID, 40 individuals with ASD, and 80 typically developed controls. Participants will undergo psychological experiments where the investigator simultaneously measure eye movement and pupil dilation using an eye-tracker. To investigate different aspects of social cognition, the investigator will use three psychological experiments: emotion recognition, emotion reappraisal, and reinforced learning in a social context. Differences in social cognition are subsequently used in predictive models to predict the group affiliation of study participants.

To evaluate the effectiveness and feasibility of an adapted emotion regulation treatment based on Dialectic Behavioral Therapy skills system (DBT-SS), the 40 study participants with ID will undergo a manual-based psychotherapy. The treatment consists of 24 group and individual sessions over 24 weeks. The treatment includes nine skill-systems. Outcome measures are administered at baseline, post-treatment, and at a 6-month follow-up.

SOCIETAL RELENVANCE

This research addresses a significant knowledge gap in social cognition and mental health in individuals with ID. The results may lead to a better understanding of differences in social cognition compared to individuals with ASD, and effective, targeted interventions for emotion regulation in individuals with ID. In the long run, the treatment could help reduce off-label prescription of antipsychotics to manage behavioral deviations in individuals with ID, as challenging behaviors often stem from difficulties with emotion regulation.

PROJECT REALISATION

The research group consists of an interdisciplinary composition of experts in neuropsychology, experimental psychology, and implementation of psychotherapeutic research. The project has obtained ethical approval and follows the principles of open science, with pre-registration of study protocols.

详细描述

BACKGROUND

Individuals with intellectual disability (ID) experience significant difficulties in interpreting, controlling, and expressing emotions. These deficits in emotion processing contribute to challenging behaviors, manifesting as aggressive outbursts, self-injurious behaviors, or withdrawal. The ability to understand and regulate emotions plays a vital role in daily functioning and social interactions. Impairment in emotion regulation also leads to increased stress, anxiety, and mood disorders, further exacerbating behavioral issues and negatively impacting the overall quality of life for individuals with ID.

Traditional cognitive tests (e.g., Wechsler Adult Intelligence Scale, WAIS) are reliable in measuring certain cognitive abilities but fall short in assessing emotional processes and social learning under uncertainty. New, objective measurement tools grounded in cognitive and neuroscience theories, would enhance our understanding of the challenges that patients with ID face in a social context.

Study has shown that Patients with ID have greater difficulty recognizing emotions compared to typically developing peers. Patients with ASD share the same functional impairment. However, the underlying mechanisms for these difficulties may differ between the two groups. For individuals with ASD, reduced fixation on the eye region has been proposed as a contributing factor to their emotion recognition difficulties, while the difficulties for individuals with ID may be due to more complex cognitive factors beyond simply reduced eye fixation.

Emotional reappraisal is a cognitive strategy used to regulate emotions by reinterpreting the meaning of emotional stimuli. It is crucial for effective emotion regulation as it allows individuals to change their emotional responses by altering their perspective on the emotional situations. For individuals with ID, the cognitive demands of reappraisal may be challenging due to limitations in executive functioning and abstract thinking, whereas for ASD, difficulties in theory of mind could impede the ability to reframe emotional situations effectively. Elucidating the exact impairment in emotion reappraisal could therefore impact assessment tools, treatment strategy and response to emotion regulation therapy.

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 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinically diagnosed with mild ID based on DSM-5 criteria, corresponding to a general IQ between 52-
  • •Can read and communicate in Swedish.

排除标准

  • •Presence of severe sensory impairments (e.g., blindness, deafness)
  • •Current psychosis or affective disorder; significant neurologic disorders (e.g., epilepsy) or degenerative disorder (e.g.., dementia, Parkinson's disease)
  • •Ongoing substance abuse
  • •Specific medication that enhance cognitive performance (central stimulants) or psychotropic medication that could affect task performance (anti-epileptic medication)
  • •Emotion regulation therapy or corresponding psychotherapy last 12 months.

研究组 & 干预措施

Emotion regulation

Experimental

DBT-SS

干预措施: Emotion regulation (Behavioral)

结局指标

主要结局

Difficulties in emotion regulation scale (DERS-SF)

时间窗: From enrollment to the end of treatment at 24 weeks

DERS-SF is a self-report questionnaire that assesses individuals' difficulties in emotion regulation. It consists of 18 questions, rated on a Likert scale of 1-5, and takes 10 minutes to complete. Total point: 18-90 Higher scores = greater emotion dysregulation

次要结局

  • World Health Organization Disability Assessment Schedule 2.0(From enrollment to the end of treatment at 24 weeks)
  • The Clinical Global Impression - Severity scale (CGI-S)(From enrollment to the end of treatment at 24 weeks)
  • Clinical Global Impression - Improvement scale (CGI-I)(From enrollment to the end of treatment at 24 weeks)
  • Client Satisfaction Questionnaire (CSQ-8)(From enrollment to the end of treatment at 24 weeks)
  • The Behavior Problems Inventory (BPI-01)(From enrollment to the end of treatment at 24 weeks)
  • Negative effects questionnaire (NEQ)(From enrollment to the end of treatment at 24 weeks)
  • Caregiver Burden Inventory(From enrollment to the end of treatment at 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Rück

Professor

Karolinska Institutet

相似试验