Cognitive Behavioral Therapy for University Students Diagnosed With Attention-deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention-deficit Hyperactivity
Status
Active
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Cognitive behavioral therapy for ADHD
Sponsored by
About this trial
This is an interventional treatment trial for Attention-deficit Hyperactivity
Eligibility Criteria
Inclusion Criteria:
University students who have previously been diagnosed with ADHD, and are fluent in Icelandic. Students with co-morbid disorders such as dyslexia, anxiety or depression will be included. Students currently receiving other psychological or medical treatment will be included.
Exclusion Criteria:
Students with psychotic disorders, autism spectrum disorders or drug dependence will be excluded.
Sites / Locations
- University of Iceland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
waiting list group
Arm Description
Cognitive behavioral therapy for ADHD
No Intervention for the waiting list group
Outcomes
Primary Outcome Measures
Beck´s Depression Inventory II
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Beck´s Depression Inventory II
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Beck´s Depression Inventory II
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Sense of coherence
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Sense of coherence
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Sense of coherence
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Well-being
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Well-being
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Well-being
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Barkley Adult ADHD rating Scale
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Barkley Adult ADHD rating Scale
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Barkley Adult ADHD rating Scale
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Rosenberg Self-Esteem Scale
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
Rosenberg Self-Esteem Scale
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
Rosenberg Self-Esteem Scale
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
SCL-90 Anxiety subscale
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
SCL-90 Anxiety subscale
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
SCL-90 Anxiety subscale
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
Automatic Thoughts Questionnaire
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Automatic Thoughts Questionnaire
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Automatic Thoughts Questionnaire
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04714866
Brief Title
Cognitive Behavioral Therapy for University Students Diagnosed With Attention-deficit Hyperactivity Disorder (ADHD)
Official Title
Cognitive Behavioral Therapy for University Students Diagnosed With Attention-deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
June 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iceland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Drug treatment is often the first and only line of treatment available for ADHD. However, some do not benefit from medication. The importance of psychotherapy is becoming more widely accepted. In this study a group of university students diagnosed with ADHD will be offered cognitive behaviour therapy (CBT) in groups. The treatment will be provided by a Clinical Nurse Specialist in psychiatric nursing (CNS), in cooperation with school counsellors at the University of Iceland and the Reykjavík University. Brief CBT treatment will be offered, i.e. six group sessions, once a week over a period of six weeks.
Little is known about the effects of CBT for adults diagnosed with ADHD. The study could provide knowledge about the effects of CBT on depression, anxiety and ADHD, and on attitudes, for individuals with ADHD. The resulting knowledge might lead to improved well-being and increased quality of life.
Detailed Description
A treatment manual for adults with ADHD was written based on the CBT model described in Young and Bramham's Handbook on ADHD in Adults (2007), Greenberger and Padesky's Mind Over Mood (2016) and Honos-Webb's The Gift of Adult ADD (2008). Emphasis will be on collaboration, incentive, group interaction and therapy rather than didactic instruction. The manual-based group treatment will be conducted in six sessions. An web page was developed in collaboration with the Faculty of Electrical and Computer Engineering at the University of Iceland containing homework and coping skills assignments to support the participants during therapy. A pilot study has been conducted where adults (n= 5) previously diagnosed with ADHD was offered group CBT in six sessions. The usefulness and benefits of the manual and the App will be evaluated by using questionnaires. Participants was also asked about the group format. The manual and the App will be further developed in light of the pilot study's results.
University students with ADHD (n= ........) previously diagnosed by a psychiatrist or a psychologist, will be offered group CBT in six sessions. The study will be introduced to the university students by the school counsellors at the University of Iceland and Reykjavik University. The school counsellors will contact the students and offer them to take part in the therapy. Participants will be randomized into two groups: a waiting list group and a therapy group. The waiting list group will subsequently be offered treatment after a wait of approximately six months. The therapy will be provided by a CNS. CBT sessions will take place once a week over a period of six weeks.
Assessments will be conducted before the intervention (baseline), at end of treatment, and at six-month follow-up. In addition, half of the participants will be placed on a waiting list, and will be assessed at the same time as the intervention group (baseline) and again six weeks later, and again six month after that, and will serve as a waiting list comparison group. They will subsequently be offered the treatment intervention and will be included in the intervention group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy for ADHD
Arm Title
waiting list group
Arm Type
No Intervention
Arm Description
No Intervention for the waiting list group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for ADHD
Intervention Description
CBT is a time-limited and structured approach that influences change in thoughts, feelings and behavior, leading to symptom changes.
Primary Outcome Measure Information:
Title
Beck´s Depression Inventory II
Description
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Time Frame
T1 (at baseline)
Title
Beck´s Depression Inventory II
Description
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Time Frame
T2 (post-treatment after 6 weeks)
Title
Beck´s Depression Inventory II
Description
The inventory includes 21 items that measure depression and well-being during the past two weeks. Options range from 0-3 in each item. The scores can range between 0 and 63. α = 0.89 - 0.94
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
Sense of coherence
Description
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Time Frame
T1 (at baseline)
Title
Sense of coherence
Description
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Time Frame
T2 (post-treatment after 6 weeks)
Title
Sense of coherence
Description
A. Antonovsky, The inventory includes 29- items with three components; Comprehensibility, manageability and meaningfulness. The items are measured on a 7-point scale. Cronbach´s alpha 0.70-0.95
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
Well-being
Description
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Time Frame
T1 (at baseline)
Title
Well-being
Description
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Time Frame
T2 (post-treatment after 6 weeks)
Title
Well-being
Description
Dupuy, the questionnaire measures well-being and to how they feel about their inner personal state. The inventory includes 18 items that include negative and positive questions with six components; anxiety, depression, general health, positive well-being, self-control and vitality. Cronbac´s alpha 0.91-0.94
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
Barkley Adult ADHD rating Scale
Description
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Time Frame
T1 (at baseline)
Title
Barkley Adult ADHD rating Scale
Description
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Time Frame
T2 (post-treatment after 6 weeks)
Title
Barkley Adult ADHD rating Scale
Description
The questionnaire includes 18- items that are based on DSM-IV criteria for ADHD and is evaluated on a 4-point Likert scale. Cronbach's alpha 0.91-0.93 in the Icelandic version
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
Rosenberg Self-Esteem Scale
Description
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
Time Frame
T1 (at baseline)
Title
Rosenberg Self-Esteem Scale
Description
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
Time Frame
T2 (post-treatment after 6 weeks)
Title
Rosenberg Self-Esteem Scale
Description
The scale is a 10-item scale that measures global self-worth using a 4-point Likert scale. Cronbach's alpha 0.87-0.93
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
SCL-90 Anxiety subscale
Description
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
Time Frame
T1 (at baseline)
Title
SCL-90 Anxiety subscale
Description
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
Time Frame
T2 (post-treatment after 6 weeks)
Title
SCL-90 Anxiety subscale
Description
The questionnaire includes 10 items related to anxiety symptoms that are evaluated on a 5-point Likert scale. Cronbach's alpha 0.90
Time Frame
T3 (follow-up 4-6 months post treatment)
Title
Automatic Thoughts Questionnaire
Description
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Time Frame
T1 (at baseline)
Title
Automatic Thoughts Questionnaire
Description
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Time Frame
T2 (post-treatment after 6 weeks)
Title
Automatic Thoughts Questionnaire
Description
The scale includes 30-item self-statements that measures the frequency of automatic negative thoughts. Thoughts are evaluated on a 5-point scale, how frequent the thoughts are. Chroma's alpha=0.96
Time Frame
T3 (follow-up 4-6 months post treatment)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
University students who have previously been diagnosed with ADHD, and are fluent in Icelandic. Students with co-morbid disorders such as dyslexia, anxiety or depression will be included. Students currently receiving other psychological or medical treatment will be included.
Exclusion Criteria:
Students with psychotic disorders, autism spectrum disorders or drug dependence will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erla K Svavarsdottir, PhD
Organizational Affiliation
University of Iceland
Official's Role
Study Director
Facility Information:
Facility Name
University of Iceland
City
Reykjavik
State/Province
Sæmundargata 2
ZIP/Postal Code
102
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Behavioral Therapy for University Students Diagnosed With Attention-deficit Hyperactivity Disorder (ADHD)
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