Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation

NCT04090983 | Completed

• 1 other identifier: KI-2019-02444
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.

Conditions

ADHD Predominantly Inattentive Type

Outcome Measures

Primary Outcomes (2)

• Behavioral Activation for Depression Scale

  Total score 0-150; higher scores represent increased activation

  14 weeks

• Pure Procrastination Scale

  Total score 12-60; higher scores represent more procrastination

  14 weeks

Study Arms (2)

Cognitive-behavioral therapy (Hesslinger protocol)

ACTIVE COMPARATOR

Behavioral: Cognitive-behavioral therapy (Hesslinger protocol)

Cognitive-behavioral therapy (CADDI protocol)

EXPERIMENTAL

Behavioral: Cognitive-behavioral therapy (CADDI protocol)

Interventions

Cognitive-behavioral therapy (Hesslinger protocol) BEHAVIORAL

Cognitive-behavioral therapy in a group format focusing on improving symptoms of ADHD, specifically by using skills in counteracting hyperactivity and impulsiveness, and promoting mindful awareness.

Cognitive-behavioral therapy (Hesslinger protocol)

Cognitive-behavioral therapy (CADDI protocol) BEHAVIORAL

Cognitive-behavioral therapy in a group format focusing on improving inattentive symptoms of ADHD, specifically by using skills in organizing, executing, and completing activity, and promoting mindful awareness.

Cognitive-behavioral therapy (CADDI protocol)

Eligibility Criteria

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

You may qualify if:

• Principal diagnosis of ADHD inattentive presentation
• years of age or older
• If on medication, it needs to be well-established since three months, and
• Prior psycho-educational intervention

You may not qualify if:

• Intellectual impairment
• Substance use disorder
• Difficulties in adherence to medical or other treatment
• Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
• Simultaneous psychological treatment

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Psychiatry Centre Södertälje

Södertälje, Stockholm County, 15240, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Benjamin Bohman, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

SE (1)