Back to resultsGroup-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
Inclusion Criteria:
In addition to an ADHD inattentive-type diagnosis, inclusion criteria are:
- 18 years or older,
- intelligence quotient above 80-85, and
- if on medication, it needs to be well-established since three months.
Exclusion Criteria:
- autism spectrum disorder,
- ongoing substance use disorder,
- difficulties in compliance with medical or other treatment,
- social and/or psychiatric problems to such an extent that it prevents focusing on treatment, or
- ongoing cognitive-behavioral therapy.
Sites / Locations
- Capio Psykiatri AB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive-behavioral therapy
Arm Description
Outcomes
Primary Outcome Measures
Brown ADD Scales
Diagnostic measure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02889354
Brief Title
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
Official Title
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility and acceptability in a pilot study with a single group design. The study also evaluates measurements and recruiting possibilities, and effects of the intervention. Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and reasonable in regards to patient characteristics; that is, the patients are responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of treatment completion, compliance to home assignments, and credibility and relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and anxiety, and improves quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Primary Outcome Measure Information:
Title
Brown ADD Scales
Description
Diagnostic measure
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In addition to an ADHD inattentive-type diagnosis, inclusion criteria are:
18 years or older,
intelligence quotient above 80-85, and
if on medication, it needs to be well-established since three months.
Exclusion Criteria:
autism spectrum disorder,
ongoing substance use disorder,
difficulties in compliance with medical or other treatment,
social and/or psychiatric problems to such an extent that it prevents focusing on treatment, or
ongoing cognitive-behavioral therapy.
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
Capio Psykiatri AB
City
Stockholm
ZIP/Postal Code
136 40
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
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