Clinical trial NCT07021274: DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.
Official title: DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation: a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difficulties of Emotion Regulation
Self-harm Behavior
Suicide Behavior
Feasibility Studies
Keywords: Autisim
emotion regulation
DBT skills training
adults
ASD
Feasibility
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: The Dam Foundation
First posted: 2025-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention
Primary purpose: TREATMENT

Brief summary: One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.

Detailed description: Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition marked by difficulties in social interaction, communication, sensory sensitivities, and repetitive behaviors. ASD varies widely among individuals and has become more recognized over time. The prevalence of ASD has significantly increased, with the U.S Centers for Disease Control and Prevention (CDC) reporting a rise from 1 in 2,222 children in 1968 to 1 in 44 children in 2020. This increase is due to evolving definitions, greater awareness, and differences in study methodologies.

Many individuals with ASD, especially those without intellectual disabilities, often remain undiagnosed until adulthood. Undiagnosed ASD is common in adult clinical populations, with a Swedish study finding that 18.9% of psychiatric outpatients had ASD. Psychiatric comorbidities are frequent in ASD, including anxiety, depression, attention deficit hyperactity disorder (ADHD), obsessive compulsive disorder (OCD), bipolar disorders, and sleep-wake disorders, complicating diagnosis and treatment. Autistic individuals often engage in suicidal behaviors, self-harm, and aggression, impacting daily life.

Autistic women without intellectual disabilities are often underdiagnosed due to less overt symptoms and their ability to camouflage difficulties. Misdiagnosis with personality disorders, particularly borderline personality disorder, is common.

Despite rising diagnosis rates, there is a lack of evidence-based treatment options for autistic adults, especially for those with comorbid mental disorders. Many clinicians lack training to work with autistic adults, and ASD specialists often lack expertise in treating co-occurring conditions. In Norway, there is a significant gap in treatment options for autistic adults without intellectual disabilities.

Emotion regulation difficulties are central challenges for many autistic adults, involving physiological arousal, brain region alterations, and unique ASD mechanisms like cognitive rigidity. Autistic adults often struggle with alexithymia, exacerbating emotion regulation issues. Developing effective emotion regulation strategies can improve quality of life.

Dialectical Behavior Therapy (DBT) helps autistic individuals manage emotions, relationships, and crises. DBT has shown effectiveness in reducing self-harm and suicidal behaviors among autistic adults. A study in North Carolina found DBT skills training feasible and acceptable for autistic adults without intellectual impairment. Similar studies have not been conducted in Nordic countries for outpatient psychiatric settings.

This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention. In the project period approximatly 15 patients will be invited to participate, referred to the project by a therapist form an general outpatient psychiatric clinic.

Primary objectives

If the DBT-skills training is relevant - The severity of difficulties in emotion regulation for the population, and the presences of destructive behaviour such as self-harm and suicide behaviour.

If DBT-skills training is accepted by tracking the dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.

Acceptability and Feasibility post treatment by evaluating participants' experiences with the treatment, and use of unhelpful and helpful strategies with self-rapport instruments.

Secondary objectives

Tracking the change in two target behaviors and four target emotions and use of skills in the treatment period with a diary card.

Assessing goals, hinders, and resources at the start and completion of the DBT skills training, with a qualitative interview.

Strength and limitations

Strength: This is a feasibility study in naturalistic treatment, making the results generalizable.

The result of the study gives relevant information in a population that is often excluded from studies because of ASD diagnosis.

Limitations: With a lack of a randomized control group, one cannot measure the direct effect of the intervention.

Future research: If the intervention fits the progression criteria and proves to be relevant, feasible, acceptable, and of potential benefit for the patients, the future aim is to conduct a Randomized Control Trial (RCT) on the effect of DBT skills training for autistic adults with difficulties in emotion regulation.

Eligibility criteria: Inclusion Criteria:

* Fit general inclusion criteria for the out- patient treatment at the clinic.

Have diagnosed autism, and pervasive difficulties in emotion regulation.

Speak Scandinavian (Norwegian, Danish and/or Swedish).

Manage to commit to participating in the DBT- skills training.

Be willing to sign the written informed consent.

Exclusion Criteria:

* Have a clinically significant low linguistic functioning that hinders the patient in understanding and answering the questions on the self-report instruments.

Being actively psychotic.

Have a Body Mass Index (BMI) under 17.

Cognitive disability Intelliganve quotient (IQ) \<85

Primary outcomes:
measure: Difficulties in emotion regulation scale (DERS) - 8
timeFrame: From enrollment to the end of treatment at 28 weeks.
measure: participation in treatment
timeFrame: From enrollment to the end of treatment at 28 weeks.
measure: Dialectical Behavior Therapy- Ways of Coping Checklist (DBT-WCCL)
timeFrame: From enrollment to the end of treatment at 28 weeks.
Secondary outcomes:
measure: Diary card
timeFrame: From enrollment to the end of treatment at 28 weeks.
measure: Qualitative interview guide - DBT skills training ASD
timeFrame: From enrollment to the end of treatment at 28 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: More And Romsdal Hospital Trust
name: Egil Jonsbu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Bargiela S, Steward R, Mandy W. The Experiences of Late-diagnosed Women with Autism Spectrum Conditions: An Investigation of the Female Autism Phenotype. J Autism Dev Disord. 2016 Oct;46(10):3281-94. doi: 10.1007/s10803-016-2872-8.