- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889354
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
August 22, 2017 updated by: Benjamin Bohman, Karolinska Institutet
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type: a Pilot Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden, 136 40
- Capio Psykiatri AB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive-behavioral therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brown ADD Scales
Time Frame: 14 weeks
|
Diagnostic measure
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Bohman, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
August 31, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Actual)
August 23, 2017
Last Update Submitted That Met QC Criteria
August 22, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KI-2016/255-31/5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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