Cognitive Behavioral Therapy for University Students Diagnosed With Attention-deficit Hyperactivity Disorder (ADHD)

NCT04714866 | Unknown DMC

• 1 other identifier: UI-HAM
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-deficit Hyperactivity

Outcome Measures

Primary Outcomes (21)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

• 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

  T1 (at baseline)

• 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

  T2 (post-treatment after 6 weeks)

• 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

  T3 (follow-up 4-6 months post treatment)

Study Arms (2)

Interventional group

EXPERIMENTAL

Cognitive behavioral therapy for ADHD

Behavioral: Cognitive behavioral therapy for ADHD

waiting list group

NO INTERVENTION

No Intervention for the waiting list group

Interventions

Cognitive behavioral therapy for ADHD BEHAVIORAL

CBT is a time-limited and structured approach that influences change in thoughts, feelings and behavior, leading to symptom changes.

Interventional group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Students with psychotic disorders, autism spectrum disorders or drug dependence will be excluded.

Sponsors & Collaborators

• University of Iceland: lead

Study Sites (1)

University of Iceland

Reykjavik, Sæmundargata 2, 102, Iceland

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Erla K Svavarsdottir, PhD

  University of Iceland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 19, 2021
• Study Start: October 11, 2018
• Primary Completion: March 5, 2020
• Study Completion: December 31, 2024
• Last Updated: May 13, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)