Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism

NCT ID: NCT05502484

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-07-31

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.

Conditions

Autism Spectrum Disorder; Regulation, Self

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4 weeks baseline followed by Integrative DBT

Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT.

Group Type: EXPERIMENTAL

Integrative Dialectical Behavioural Therapy (DBT)

Intervention Type: BEHAVIORAL

8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism.

6 weeks baseline followed by Integrative DBT

Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT.

Group Type: EXPERIMENTAL

Integrative Dialectical Behavioural Therapy (DBT)

Intervention Type: BEHAVIORAL

8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism.

8 weeks baseline followed by Integrative DBT

Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT.

Group Type: EXPERIMENTAL

Integrative Dialectical Behavioural Therapy (DBT)

Intervention Type: BEHAVIORAL

8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism.

Interventions

Integrative Dialectical Behavioural Therapy (DBT)

8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dimence mental health institute

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ella Lobregt-van Buuren, MSc

Role: PRINCIPAL_INVESTIGATOR

Dimence mental health institute

Nanda Lambregts-Rommelse, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Wouter Staal, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Lisette Verhoeven, PhD

Role: STUDY_CHAIR

Dr. Leo Kannerhuis

Peter Goossens, PhD

Role: STUDY_CHAIR

Dimence mental health institute

Locations

Dimence mental health institute

Deventer, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

DASHBOARD

Identifier Type: -

Identifier Source: org_study_id