Emotion Processing and Regulation in People With Intellectual Disability

NCT06894264 | Not Yet Recruiting

• 1 other identifier: EPRID
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intellectual Disabilities (F70-F79); Autism Spectrum Disorder

Keywords

Emotion regulation; Psychological experiment; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Difficulties in emotion regulation scale (DERS-SF)

  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

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (7)

• 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

Study Arms (1)

Emotion regulation

EXPERIMENTAL

DBT-SS

Behavioral: Emotion regulation

Interventions

Emotion regulation BEHAVIORAL

The intervention is an adapted version of skills training that stems from DBT. The text has been simplified, and illustrations have been added to facilitate learning. It consists of nine skill-systems that are delivered during 24 weeks, one group session and individual therapy session per week. A licensed psychologist is responsible for each individual treatment. Care givers or relatives are given support and encouraged to participate and help the study participant to complete their homework assignments.

Emotion regulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (13)

• Rosendahl-Santillo A, Lantto R, Nylander L, Thylander C, Schultz P, Brown J, Wallinius M, Westling S. Dialectical behavior therapy-skills system for cognitively challenged individuals with self-harm: a Swedish pilot study. Int J Dev Disabil. 2021 Sep 1;69(4):533-545. doi: 10.1080/20473869.2021.1965825. eCollection 2023.

  PMID: 37346252 BACKGROUND

• Brown JF, Brown MZ, Dibiasio P. Treating Individuals With Intellectual Disabilities and Challenging Behaviors With Adapted Dialectical Behavior Therapy. J Ment Health Res Intellect Disabil. 2013 Oct;6(4):280-303. doi: 10.1080/19315864.2012.700684.

  PMID: 23914278 BACKGROUND

• Linehan MM, Wilks CR. The Course and Evolution of Dialectical Behavior Therapy. Am J Psychother. 2015;69(2):97-110. doi: 10.1176/appi.psychotherapy.2015.69.2.97.

  PMID: 26160617 BACKGROUND

• Jahoda A, Dagnan D, Hastings R, Gillooly A, Miller J, Baines S, Hatton C. Adapting psychological interventions for people with severe and profound intellectual disabilities: A behavioural activation exemplar. J Appl Res Intellect Disabil. 2024 Mar;37(2):e13199. doi: 10.1111/jar.13199.

  PMID: 38361369 BACKGROUND

• Campos-Jara R, Martinez-Salazar C, Campos-Jara C, Fernandez JM, Martinez-Garcia D, Contreras-Osorio F. Pharmacological treatment for challenging behavior in adults with intellectual disability: Systematic review and meta-analysis. Span J Psychiatry Ment Health. 2024 Oct-Dec;17(4):231-238. doi: 10.1016/j.rpsm.2023.01.003. Epub 2023 Jan 31.

  PMID: 37839961 BACKGROUND

• Kleberg JL, Willfors C, Bjorlin Avdic H, Riby D, Galazka MA, Guath M, Nordgren A, Strannegard C. Social feedback enhances learning in Williams syndrome. Sci Rep. 2023 Jan 4;13(1):164. doi: 10.1038/s41598-022-26055-8.

  PMID: 36599864 BACKGROUND

• Garrison J, Erdeniz B, Done J. Prediction error in reinforcement learning: a meta-analysis of neuroimaging studies. Neurosci Biobehav Rev. 2013 Aug;37(7):1297-310. doi: 10.1016/j.neubiorev.2013.03.023. Epub 2013 Apr 6.

  PMID: 23567522 BACKGROUND

• Subramanian A, Chitlangia S, Baths V. Reinforcement learning and its connections with neuroscience and psychology. Neural Netw. 2022 Jan;145:271-287. doi: 10.1016/j.neunet.2021.10.003. Epub 2021 Oct 22.

  PMID: 34781215 BACKGROUND

• Littlewood M, Dagnan D, Rodgers J. Exploring the emotion regulation strategies used by adults with intellectual disabilities. Int J Dev Disabil. 2018 Jun 8;64(3):204-211. doi: 10.1080/20473869.2018.1466510.

  PMID: 34141307 BACKGROUND

• Samson AC, Sokhn N, Van Herwegen J, Dukes D. An exploratory study on emotion regulation strategy use in individuals with Williams syndrome, autism spectrum disorder and intellectual disability. Front Psychiatry. 2022 Nov 23;13:940872. doi: 10.3389/fpsyt.2022.940872. eCollection 2022.

  PMID: 36506439 BACKGROUND

• Jenner LA, Farran EK, Welham A, Jones C, Moss J. The use of eye-tracking technology as a tool to evaluate social cognition in people with an intellectual disability: a systematic review and meta-analysis. J Neurodev Disord. 2023 Dec 4;15(1):42. doi: 10.1186/s11689-023-09506-9.

  PMID: 38044457 BACKGROUND

• Scotland JL, McKenzie K, Cossar J, Murray A, Michie A. Recognition of facial expressions of emotion by adults with intellectual disability: Is there evidence for the emotion specificity hypothesis? Res Dev Disabil. 2016 Jan;48:69-78. doi: 10.1016/j.ridd.2015.10.018. Epub 2015 Nov 5.

  PMID: 26546741 BACKGROUND

• Hermann H, Berndt N, Lytochkin A, Sappok T. Behavioural phenomena in persons with an intellectual developmental disorder according to the level of emotional development. J Intellect Disabil Res. 2022 May;66(5):483-498. doi: 10.1111/jir.12930. Epub 2022 Mar 31.

  PMID: 35357054 BACKGROUND

MeSH Terms

Conditions

Intellectual Disability; Autism Spectrum Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Self-Control; Social Behavior; Behavior

Central Study Contacts

Long-Long Chen postdoctoral student, MD PhD

CONTACT

+46 0725670088; long.chen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 25, 2025
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share