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

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04090983
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Cognitive-behavioral therapy (Hesslinger protocol)
  • Behavioral: Cognitive-behavioral therapy (CADDI protocol)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 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 :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral Activation for Depression Scale [14 weeks]

    Total score 0-150; higher scores represent increased activation

  2. Pure Procrastination Scale [14 weeks]

    Total score 12-60; higher scores represent more procrastination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatry Centre Södertälje Södertälje Stockholm Sweden 15240

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Benjamin Bohman, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin Bohman, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04090983
Other Study ID Numbers:
  • KI-2019-02444
First Posted:
Sep 16, 2019
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Sep 1, 2021