Protocol summary

Study aim
To investigate the effectiveness of cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) on reducing attention deficit hyperactivity disorder (ADHD) symptoms, cognitive disengagement syndrome, improving executive functions, quality of life, and stress management in adults with ADHD.
Design
This study is a randomized clinical trial with parallel groups, which includes two intervention groups and a control group. The sample size for epidemiology was 1000 girls and boys. Random allocation was performed. The sample size was 60 people (each group about 20 people).
Settings and conduct
The study was conducted at Persian Gulf University and affiliated counseling centers. After screening 1000 students, 60 eligible participants were randomly assigned to CBT, MBCT, or control groups. Standardized executive function tests and questionnaires were administered, followed by group therapy sessions, posttest, and two-month follow-up.
Participants/Inclusion and exclusion criteria
Diagnosis of ADHD in adulthood based on clinical interview and DSM-5 criteria. Age 18 to 40 years; Having a severe psychiatric disorder (such as schizophrenia or bipolar disorder). Substance dependence or active substance abuse. Receiving concomitant psychological treatment or taking a cognitive-altering medication during the study period.
Intervention groups
CBT group: Group cognitive-behavioral therapy. MBCT group: Group mindfulness-based cognitive therapy. Control group: Placed on a waiting list and did not receive the intervention.
Main outcome variables
Reduction of symptoms of ADHD (attention, hyperactivity, impulsivity); reduction of CDS; improvement of executive functions; improvement of quality of life; improvement of stress management

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250927067383N1
Registration date: 2025-10-07, 1404/07/15
Registration timing: retrospective

Last update: 2025-10-07, 1404/07/15
Update count: 0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
leila kamran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 001 8657
Email address
l.kamran92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy on Executive Functions, Cognitive Disengagement Syndrome, Stress Management, and Quality of Life in Adults with ADHD
Public title
Effectiveness of Cognitive-Behavioral and Mindfulness-Based Therapies in Adults with Attention-Deficit/Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18- 40 years old Sufficient motivation
Exclusion criteria:
History of neurological disorders Color blindness Lack of computer knowledge
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method of this study is multi-stage cluster random sampling, and the assignment of subjects to groups is also random.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: Individuals enrolled in the study were aware of the type of treatment they were receiving (cognitive-behavioral or cognitive-mindfulness), but were not accurately informed of the existence of a control group and between-group comparisons to reduce the expectation effect. Principal Investigator: The principal investigator, who was responsible for data analysis, was not aware of the coding of groups (A, B, and C) until the end of data collection, and analyses were conducted as anonymous data. Therapists: Due to the nature of psychological interventions, therapists were aware of the type of intervention they were implementing and there was no possibility of blinding them. Healthcare personnel: Because the intervention was implemented in an academic setting and by a trained researcher, clinical personnel had no involvement in the treatment and care of participants. Data collectors and outcome assessors: The individuals who collected and scored the questionnaires were unaware of the type of intervention and the grouping of participants. The questionnaires were delivered and analyzed with only the participants' anonymous codes (without mentioning the treatment group). Authors of the final report: The initial writing of the article was done based on the coded data (without disclosing the groups) and only after the statistical analyses were completed, the group codes were opened and the results were interpreted accordingly.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Asadabadi Street, Alley 3, Parsam Building, Unit 8
City
Shiraz
Province
Fars
Postal code
7134944323
Approval date
2025-08-12, 1404/05/21
Ethics committee reference number
IR.BPUMS.REC.1404.255

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Inattention score measured by the Barkley Adult ADHD Rating Scale-IV (BAARS-IV).Hyperactivity score measured by the BAARS-IV.Impulsivity score measured by the BAARS-IV.Sluggish Cognitive Tempo (SCT) score measured by the BAARS-IV and performance-based tests.Cold executive functions (cognitive flexibility, sustained attention, response inhibition, planning) measured by the Wisconsin Card Sorting Test (WCST), Stroop Test, Tower of London, and Continuous Performance Test (CPT).Hot executive functions (emotion regulation and decision-making) measured by related questionnaires and decision-making tasks.Quality of life measured by the Adult ADHD Quality of Life Questionnaire (AAQoL).Stress management measured by the Depression Anxiety Stress Scales (DASS-21).
Timepoint
Pre-test before the intervention begins, post-test immediately after the end of the treatment sessions, and follow-up 2 months after the end of treatment.
Method of measurement
Barclay Adult Attention-Deficit Hyperactivity Disorder Rating Scale, Adult ADHD Quality of Life Scale (AAQoL), Depression-Anxiety-Stress Scale (DASS), Stroop test, Wisconsin Card Sorting Test, Tower of London Test, Continuous Performance Test (CPT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive-behavioral therapy
Category
Treatment - Other

2

Description
Control group: No intervention was performed.
Category
Treatment - Other

3

Description
Intervention group: Mindfulness-based cognitive therapy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Persian gulf university
Full name of responsible person
Leila Kamran
Street address
Bushehr, Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 917 001 8657
Email
l.kamran92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Persian Gulf University
Full name of responsible person
Leila Kamran
Street address
Bushehr, Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 917 001 8657
Email
l.kamran92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Persian Gulf University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Leila Kamran
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bushehr, Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
0773122
Email
l.kamran92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Leila Kamran
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bushehr, Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
0773122
Email
l.kamran92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Leila kamran
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bushehr, Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۶۹۱۳۸۱۷
Phone
0773122
Email
l.kamran92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
From the time of defense for 6 months
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No analysis or use is permitted.
From where data/document is obtainable
To receive data/documents, please contact your supervisor, Dr. Golestaneh, at the email address golestaneh@pgu.ac.ir.
What processes are involved for a request to access data/document
Approval from researcher, supervisors and advisors
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