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Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Stockholm Health Care Services, Region Stockholm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive-behavioral therapy

Arm Description

Cognitive-behavioral therapy, including behavioral exercises and homework assignments.

Outcomes

Primary Outcome Measures

Qualitative interview data
Participant responses based on questions posed in an interview

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
February 27, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05037903
Brief Title
Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study
Official Title
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: A Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

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
This is a qualitative study of participants who have taken part in a randomized controlled trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose of the qualitative study is to explore participant perceptions of taking part in the RCT to further develop and improve the new treatment protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-behavioral therapy
Arm Type
Experimental
Arm Description
Cognitive-behavioral therapy, including behavioral exercises and homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
Cognitive and behavioral interventions aimed at increasing behavioral activation, and reducing procrastination and inattentive symptoms.
Primary Outcome Measure Information:
Title
Qualitative interview data
Description
Participant responses based on questions posed in an interview
Time Frame
45-60 minutes

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
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm Health Care Services, Region Stockholm
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study

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