Back to resultsCognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation
Primary Purpose
ADHD Predominantly Inattentive Type
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive-behavioral therapy (Hesslinger protocol)
Cognitive-behavioral therapy (CADDI protocol)
Sponsored by
About this trial
This is an interventional treatment trial for ADHD Predominantly Inattentive Type
Eligibility Criteria
Inclusion Criteria:
- Principal diagnosis of ADHD inattentive presentation
- 18 years of age or older
- If on medication, it needs to be well-established since three months, and
- Prior psycho-educational intervention
Exclusion Criteria:
- 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
Sites / Locations
- Psychiatry Centre Södertälje
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive-behavioral therapy (Hesslinger protocol)
Cognitive-behavioral therapy (CADDI protocol)
Arm Description
Outcomes
Primary Outcome Measures
Behavioral Activation for Depression Scale
Total score 0-150; higher scores represent increased activation
Pure Procrastination Scale
Total score 12-60; higher scores represent more procrastination
Secondary Outcome Measures
Full Information
NCT ID
NCT04090983
First Posted
September 13, 2019
Last Updated
October 9, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04090983
Brief Title
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation
Official Title
Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD Predominantly Inattentive Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy (Hesslinger protocol)
Arm Type
Active Comparator
Arm Title
Cognitive-behavioral therapy (CADDI protocol)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy (Hesslinger protocol)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy (CADDI protocol)
Intervention Description
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 Measure Information:
Title
Behavioral Activation for Depression Scale
Description
Total score 0-150; higher scores represent increased activation
Time Frame
14 weeks
Title
Pure Procrastination Scale
Description
Total score 12-60; higher scores represent more procrastination
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Principal diagnosis of ADHD inattentive presentation
18 years of age or older
If on medication, it needs to be well-established since three months, and
Prior psycho-educational intervention
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Bohman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry Centre Södertälje
City
Södertälje
State/Province
Stockholm
ZIP/Postal Code
15240
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation
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