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

March 8, 2024 updated by: Benjamin Bohman, Karolinska Institutet

Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Stockholm
      • Södertälje, Stockholm, Sweden, 15240
        • Psychiatry Centre Södertälje

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Principal diagnosis of ADHD inattentive presentation
  2. 18 years of age or older
  3. If on medication, it needs to be well-established since three months, and
  4. Prior psycho-educational intervention

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive-behavioral therapy (Hesslinger protocol)
Behavioral: Cognitive-behavioral therapy (Hesslinger protocol)
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.
Experimental: Cognitive-behavioral therapy (CADDI protocol)
Behavioral: Cognitive-behavioral therapy (CADDI protocol)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Activation for Depression Scale
Time Frame: 14 weeks
Total score 0-150; higher scores represent increased activation
14 weeks
Pure Procrastination Scale
Time Frame: 14 weeks
Total score 12-60; higher scores represent more procrastination
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Benjamin Bohman, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI-2019-02444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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