Short Structured Psychological Intervention for Adults With ADHD - a Randomized Controlled Trial

NCT04439422 | Unknown

• 1 other identifier: SAINT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of a novel psychological intervention for adult ADHD through a randomized controlled trial. Participants will be randomized to receive either a face-to-face manualized short psychological intervention, SAINT, or corresponding self-help material with limited access to therapist support. The main objective is to evaluate whether SAINT will show better outcomes on measures of ADHD-related symptoms, everyday function, and quality-of-life measures, when compared to the self-help material, and if any possible differences in outcomes are related to better treatment adherence in SAINT.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Attention Deficit; Psychological Intervention; CBT; DBT; Self-Help; Adherence; Short Intervention

Outcome Measures

Primary Outcomes (1)

• Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)

  Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

Secondary Outcomes (8)

• Change (from baseline) on ADHD Self-Report Scale (ASRS; Self-report)

  Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

• Change (from baseline) on the ADHD Rating Scale (ADHD RS; Assessed by an expert rater)

  Baseline, 5 weeks (post treatment)

• Change (from baseline) on Montgomery Åsberg Depression Rating Scale (MADRS-S; Self-report)

  Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

• Change (from baseline) on Sheehan Disability Scale (SDS; Self-report)

  Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

• Change (from baseline) on Difficulties in Emotion Regulation Scale (Brief Version; DERS-16; Self-report)

  Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

Other Outcomes (8)

• Clinical Global Impression - Improvement Scale (CGI-I; Assessed by an expert rater)

  5 weeks (post treatment)

• Client Satisfaction Questionnaire (CSQ-8; Self-report)

  5 weeks (post treatment)

• Treatment Credibility Scale (TCS; Self-report)

  1 week, 3 weeks

Study Arms (2)

SAINT

EXPERIMENTAL

Behavioral: Short ADHD Intervention

Self-help material

ACTIVE COMPARATOR

Other: Self-help material with limited therapist support

Interventions

Short ADHD Intervention BEHAVIORAL

Short, intensive psychological intervention based on CBT and DBT practices

Also known as: SAINT

SAINT

Self-help material with limited therapist support OTHER

Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)

Self-help material

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Swedish citizen
• Clinical Diagnosis of ADHD according to DSM-IV or DSM-5.
• Score of 17 or higher on the Adult ADHD Self Report Scale (ASRS v1.1), on any one of the two subscales.
• Not medically treated for ADHD symptoms throughout the study period, or medically treated with central stimulants or comparable substances since at least one month, with no significant changes in dosage and no anticipated significant changes in dosage.
• No change in any other medical treatment for psychiatric symptoms.
• Ability to participate in treatment during the study period.
• Abstinence from illegal substance use for at least three months.
• Access to and ability to use Internet and mobile phone during the study period.
• Ability to understand Swedish in speech and writing, and ability to fill-out forms online.

You may not qualify if:

• Clinical diagnosis of substance use disorder within three months prior to screening. Earlier episodic use of illegal substances is not excluding.
• Co-existing psychiatric condition or disorder expected to render the participant unable to follow-through the study processes.
• IQ ≤85 according to a prior neuropsychological assessment.
• Suicidality assessed at the first assessment interview.
• Organic brain syndrome.
• Autism spectrum disorder (ASD) where function is deemed too low for the treatment to be carried out, defined as ASD level 2 and level 3 according to DSM-5 and/or ASD with accompanying intellectual impairment and/or accompanying language impairment.
• Severe depression, defined as \>34 on the MADRS-S or at a clinical assessment.
• Other current psychological treatment for ADHD or prior participation in treatment deemed to interfere with the study design.
• Limited or very limited self-rated recognition of problems regarding impulse control and/or emotional instability, in combination with low self-rated impairment, on a tailor-made measure.

Sponsors & Collaborators

• Cereb AB: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Cereb AB

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Berkeh Nasri, PhD

CONTACT

+46739328138; berkeh.nasri@cereb.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Research and Development

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: August 25, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

SE (1)