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

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Short ADHD Intervention; Other: Self-help material with limited therapist support

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Cereb AB
    • Contact: Berkeh Nasri, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAINT	Behavioral: Short ADHD Intervention; Short, intensive psychological intervention based on CBT and DBT practices; Other Names: SAINT
Active Comparator: Self-help material	Other: Self-help material with limited therapist support; Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change (from baseline) on The Adult ADHD Quality of Life Questionnaire (AAQoL)	Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Change (from baseline) on Satisfaction With Life Scale (SWLS; Self-report)	Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Perceived Stress Scale (PSS; Self-report)	Baseline, 5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Change (from baseline) on Clinical Global Impression - Severity Scale (CGI-S; Assessed by an expert rater)	Baseline, 5 weeks (post treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Treatment Evaluation (Self-report)	A tailor-made formulary to evaluate the participants' experience of the interventions, including any possible difficulties.	5 weeks (post treatment)
Adherence to Treatment (Self-report)	Using a tailor-made formulary.	1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)
Session Attendance (Assessed by an expert rater)	SAINT arm only.	1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks (post treatment), 9 weeks (FU1)
Adverse Events During Treatment (Self-report)	Using a tailor-made formulary.	5 weeks (post treatment), 9 weeks (FU1) 17 weeks (FU3)
Changes in Other Treatment(s) During the Study Period (Self-report)	Using a tailor-made formulary.	5 weeks (post treatment),9 weeks (FU1) 17 weeks (FU3)

Collaborators and Investigators

• Sponsor: Cereb AB
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Adherence; ADHD; Psychological Intervention; CBT; DBT; Attention Deficit; Self-Help; Short Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: SAINT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No