Clinical trial NCT05502484: Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism
Official title: Potential Effectiveness of Integrative Dialectical Behavioural Therapy for Adults With Autism and the Role of Sensory Hyper- and Hyposensitivity and Interoceptive BOdy-Awareness in Self-Regulation Development
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Regulation, Self
Keywords: Autism Spectrum Disorder (ASD)
dialectical behavioural therapy (DBT)
self-regulation
emotion-dysregulation
body-awareness
interoception
sensory hypersensitivity
sensory hyposensitivity
non-suicidal self-injury (NSSI)
suicidal ideation
suicidal behaviour
coping skills
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dimence mental health institute
First posted: 2022-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multiple baseline design with staggered starts (randomized allocation to a baseline length of 4, 6, or 8 weeks) before starting the treatment (integrative Dialectical Behavioural Therapy).
Primary purpose: TREATMENT

Brief summary: Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation. In this study experiences of adults with ASD and severe emotion dysregulation with Integrative Dialectical Behaviour Therapy (DBT) and the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.

Detailed description: Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation and in conjunction with that they also show more maladaptive coping compared to non-autistic people. Sensory differences and impaired interoceptive body-awareness may influence emotion-dysregulation. Maladaptive coping is reflected by a variety of harmful behaviours, particularly strong social avoidance, rumination, obsessive-compulsive symptoms, disordered eating, substance abuse, agitation, non-suicidal-self-injury (NSSI), and suicidal ideation and behaviour. For a part of these individuals, treatment as usual does not have any effect at all, causing a vicious circle of isolation, demoralization, life-long psychiatric treatments, and crisis. DBT is an empirically supported psychotherapy to treat severe emotion-dysregulation. An effective inpatient treatment for adults with ASD and severe emotion-dysregulation is lacking, as well insight in the development of the process of self-regulation, particularly the role of sensory hyper- and hyposensitivity and interoceptive body-awareness. Therefore, an integrative, mostly inpatient treatment program based on DBT is developed and outcomes will be evaluated in the currently presented research. Standard DBT is used, adapted to adults with ASD, and augmented with a body-oriented DBT-skills training, because of their possible impairments of interoceptive body-awareness. Experiences of participants with the treatment program, the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.

The first aim is to quantify the effectiveness of integrative DBT in adults with ASD and difficult to treat severe emotion-dysregulation and maladaptive coping (primary outcome measure). The second aim is to determine the improvements over time in sensory hyper- and hyposensitivity, interoceptive body-awareness, cognitive and behavioural emotion-regulation, and well-being. Moreover, we will explore how (full and partial) responders, non-responders and deteriorators will differ with regard to autistic traits, PTSS-symptoms, sensory hyper- and hyposensitivity and interoceptive body-awareness. The third aim is to determine how qualitative findings regarding patients' experiences with integrative DBT enhance the deeper understanding of the quantitative clinical outcomes, in order to get insight in the process and sustainability of self-regulation, and to make the treatment more tailored and effective in the pathway to recovery.

A mixed-methods strategy consisting of three elements is executed:

1. A randomized, multiple-baseline single-case design with staggered baselines of 4, 6, or 8 weeks (randomized allocation) and daily measurements of emotion dysregulation.
2. A quasi-experimental design with 5 measurements with questionnaires at baseline (T0), start outpatient DBT pretreatment of 8 weeks (T1), start inpatient DBT of 40 weeks (T2), end inpatient DBT (T3), and end follow-up of 24 weeks (T4).
3. A qualitative study consisting of interviews with 30 participants.

Eligibility criteria: The inclusion criteria to enroll in the study are the same as the inclusion criteria for integrative DBT. Inclusion Criteria:

* Age ≥ 18 years old.
* A clinical diagnosis of ASD as diagnosed by a qualified health care professional (in Dutch: BIG registration).
* Non-responding to TAU (treatment as usual) for at least a year.
* IQ ≥ 85, based upon previous levels of education or previous IQ test, when available.
* Consent from the participant to record the DBT sessions on video or audio for supervision and assessing therapy integrity.
* Proficient in the Dutch language.
* Motivation to address problems through integrative DBT.
* Ability to work on treatment goals in collaboration with multiple therapists and counselors and to function in a group of maximal 8 adults with ASD.

Exclusion Criteria:

- Severe, current psychotic and manic symptoms, severe substance abuse disorder and eating disorder, requiring other specialized treatment first.

Primary outcomes:
measure: Maladaptive coping: using harmful behaviours
timeFrame: Change during inpatient treatment (phase C, 40 weeks)
Secondary outcomes:
measure: Non Suicidal Self Injury (NSSI)
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Suicidal ideation
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Interoceptive body-awareness
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Emotion-dysregulation
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Cognitive emotion-regulation
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Behavioural emotion-regulation
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Sensory sensitivity
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Well-being
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
measure: Maladaptive coping: using harmful behaviours
timeFrame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during follow-up (Phase D: 24 weeks)
Other outcomes:
Locations:
city: Deventer
country: Netherlands
facility: Dimence mental health institute
state: Gelderland
Study officials:
affiliation: Dimence mental health institute
name: Ella Lobregt-van Buuren, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Nanda Lambregts-Rommelse, PhD
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Wouter Staal, PhD
role: STUDY_CHAIR
affiliation: Dr. Leo Kannerhuis
name: Lisette Verhoeven, PhD
role: STUDY_CHAIR
affiliation: Dimence mental health institute
name: Peter Goossens, PhD
role: STUDY_CHAIR
References: