Clinical trial NCT04714866: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention-deficit Hyperactivity
Lead sponsor: University of Iceland
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Beck´s Depression Inventory II
timeFrame: T1 (at baseline)
measure: Beck´s Depression Inventory II
timeFrame: T2 (post-treatment after 6 weeks)
measure: Beck´s Depression Inventory II
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: Sense of coherence
timeFrame: T1 (at baseline)
measure: Sense of coherence
timeFrame: T2 (post-treatment after 6 weeks)
measure: Sense of coherence
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: Well-being
timeFrame: T1 (at baseline)
measure: Well-being
timeFrame: T2 (post-treatment after 6 weeks)
measure: Well-being
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: Barkley Adult ADHD rating Scale
timeFrame: T1 (at baseline)
measure: Barkley Adult ADHD rating Scale
timeFrame: T2 (post-treatment after 6 weeks)
measure: Barkley Adult ADHD rating Scale
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: Rosenberg Self-Esteem Scale
timeFrame: T1 (at baseline)
measure: Rosenberg Self-Esteem Scale
timeFrame: T2 (post-treatment after 6 weeks)
measure: Rosenberg Self-Esteem Scale
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: SCL-90 Anxiety subscale
timeFrame: T1 (at baseline)
measure: SCL-90 Anxiety subscale
timeFrame: T2 (post-treatment after 6 weeks)
measure: SCL-90 Anxiety subscale
timeFrame: T3 (follow-up 4-6 months post treatment)
measure: Automatic Thoughts Questionnaire
timeFrame: T1 (at baseline)
measure: Automatic Thoughts Questionnaire
timeFrame: T2 (post-treatment after 6 weeks)
measure: Automatic Thoughts Questionnaire
timeFrame: T3 (follow-up 4-6 months post treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: University of Iceland
state: Sæmundargata 2
Study officials:
affiliation: University of Iceland
name: Erla K Svavarsdottir, PhD
role: STUDY_DIRECTOR
References: