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NCT06894264Not yet recruiting

Emotion Processing and Regulation in People With Intellectual Disability

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
10 Feb 2025
Start date
15 Aug 2026
Primary completion date
30 Sept 2028
Lead sponsor
Karolinska Institutet
Diseases
Autism
NCT number
NCT06894264

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 15 Aug 2026 to the primary completion date, 30 Sept 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Current psychosis or affective disorder; significant neurologic disorders (e.g., epilepsy) or degenerative disorder (e.g.., dementia, Parkinson's disease)

Other

  • Presence of severe sensory impairments (e.g., blindness, deafness)
  • Ongoing substance abuse

Who the study is looking for

  • Clinically diagnosed with mild ID based on DSM-5 criteria, corresponding to a general IQ between 52-70.
  • Can read and communicate in Swedish.

Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.