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

STATUS

Recruiting
participants needed

80
sponsor

Cereb AB

Send

Updated on 19 February 2024

See if I qualify

cns stimulants

stimulant

substance use

psychiatric symptoms

attention deficit hyperactivity disorder

Summary

Show definitions

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.

Description

ADHD is associated with deficiencies in short-term memory and executive function, negatively affecting patients' abilities to organize, schedule, multitask, follow through on instructions and finish jobs. This leads to uneven performance and possibly chronic underperformance in relation to actual intellectual resources. Psychiatric comorbidity is common for patients with ADHD, with 70-80% of adult patients meeting the criteria for at least one more clinical diagnosis. ADHD is also associated with sensation seeking and reckless behavior, including substance use and criminal activity.

Despite an increase in demand for assessment and treatment of ADHD among adults, access to evidence-based treatment is limited. In Sweden, most adult patients with ADHD are only offered pharmacological treatment. Pharmacological treatment, while in many cases effective, does not meet the demands of all patients, with 20-50% of patients not experiencing enough initial effect and/or excessive side-effects. Pharmacological treatment of ADHD also shows problems with long-term adherence, with approximately half of patients terminating treatment within the first two years, regardless of initial effect. Research on psychological treatment for adult ADHD is limited, though studies on behavioral treatment, including short-term therapies based on cognitive behavior therapy (CBT) and dialectic behavior therapy (DBT), have shown promising results.

This project, dubbed Short ADHD Intervention (SAINT), is based on previous research and pilot-studies of psychological treatments for adult ADHD. An existing treatment manual, based on CBT and DBT practices, will be fitted into a five-session, intensive face-to-face behavioral intervention, with a booster session at a one-month follow-up. The intervention will be compared to an equally long, active comparative control, consisting of self-help material and limited therapist support via Internet. Approximately 80 participants will be recruited at outpatient clinics in Stockholm. The participants will be randomized to receive either SAINT or the self-help material and limited therapist support.

Details

Condition	Oppositional Defiant Disorder, Attention deficit hyperactivity disorder
Age	18years - 65years
Treatment	Short ADHD Intervention, Self-help material with limited therapist support
Clinical Study Identifier	NCT04439422
Sponsor	Cereb AB
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

attention deficit hyperactivity disorder

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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