Skip to main content
Clinical Trials/NCT02463396
NCT02463396CompletedNot Applicable

Mindfulness Training Versus Treatment as Usual in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Radboud University Medical Center1 site in 1 country120 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Change from baseline in investigator-rated ADHD symptoms

Study Overview

Brief Summary

The primary aim of this study is to investigate clinical effectiveness of mindfulness training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD). The secondary aim is to assess whether mindfulness training is cost-effective compared to TAU in adults with ADHD from a societal perspective.

Detailed Description

RATIONALE Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder with a high persistence into adulthood. Patients with ADHD are primarily offered stimulant medication. However, not all patients are willing to take medication, some suffer from unacceptable side-effects and for many medication does not reduce their symptoms to the degree they would wish for. Therefore, there is a strong need for effective psychosocial interventions that are both accessible to a large group of patients and have been shown to be cost-effective, such as mindfulness training.

OBJECTIVE To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).

HYPOTHESIS Mindfulness training will result in less ADHD symptoms, a better executive functioning, a better quality of life, and lower health care and societal costs.

STUDY DESIGN Randomised trial comparing mindfulness in addition to TAU with TAU alone. Baseline, end of treatment, follow-up 1 (6 months after baseline) and follow-up 2 (9 months after baseline) assessments will be done by blinded assessors and self-report questionnaires. After 9 months, patients allocated to the TAU condition will be offered mindfulness as well.

STUDY POPULATION N=120 adults with ADHD according to the DSM-5 using a structured psychiatric interview, referred to Radboudumc in Nijmegen, Reinier van Arkel in 's Hertogenbosch and Dimence in Deventer.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The investigators will include patients of 18 years and older who meet the following criteria:
  • •a primary diagnosis of ADHD, according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV-TR) based on a structured Diagnostic Interview for ADHD, in adults (DIVA)
  • •capable of filling out questionnaires in Dutch

Exclusion Criteria

  • •depressive disorder with psychotic symptoms or suicidality
  • •active manic episode
  • •borderline or antisocial personality disorder
  • •substance dependence
  • •autism spectrum disorder
  • •tic disorder with vocal tics
  • •learning difficulties or other cognitive impairments
  • •former participation in a MBCT or MBSR course

Arms & Interventions

Mindfulness Based Cognitive Therapy (MBCT) for ADHD

Experimental

Adapted MBCT for ADHD

Intervention: MBCT for ADHD (Behavioral)

Treatment as usual (TAU)

No Intervention

Usually medication & psycho-education

Outcomes

Primary Outcomes

Change from baseline in investigator-rated ADHD symptoms

Time Frame: baseline, 3, 6 and 9 months

Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)

Secondary Outcomes

  • Change from baseline in self-reported ADHD symptoms(baseline, 3, 6 and 9 months)
  • Change from baseline in executive functioning(baseline, 3, 6 and 9 months)
  • Change from baseline in self-compassion(baseline, 3, 6 and 9 months)
  • Change from baseline in positive mental health(baseline, 3, 6 and 9 months)
  • Change from baseline in patient functioning(baseline, 3, 6 and 9 months)
  • Change from baseline in health care consumption and productivity loss(baseline, 3, 6 and 9 months)
  • Change from baseline in mindfulness skills(baseline, 3, 6 and 9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Mindfulness Training in Adults With ADHD | Clinical Trial