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

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ClinicalTrials.gov Identifier: NCT04090983
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Bohman, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
ADHD Predominantly Inattentive Type Behavioral: Cognitive-behavioral therapy (Hesslinger protocol) Behavioral: Cognitive-behavioral therapy (CADDI protocol) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Behavioral Activation for Depression Scale [ Time Frame: 14 weeks ]
    Total score 0-150; higher scores represent increased activation

  2. Pure Procrastination Scale [ Time Frame: 14 weeks ]
    Total score 12-60; higher scores represent more procrastination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090983


Contacts
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Contact: Benjamin Bohman, PhD (0)72 244 49 00 ext +46 benjamin.bohman@ki.se
Contact: Elinor Eskilsson Strålin, MSc (0)73 158 36 89 ext +46 elinor.eskilsson.stralin@ki.se

Locations
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Sweden
Psychiatry Centre Södertälje Recruiting
Södertälje, Stockholm, Sweden, 15240
Contact: Elinor Eskilsson Strålin, MSc    (0) 73 158 36 89 ext +46    elinor.eskilsson.stralin@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Benjamin Bohman, PhD Karolinska Institutet

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Responsible Party: Benjamin Bohman, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04090983     History of Changes
Other Study ID Numbers: KI-2019-02444
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders