The Effectiveness of the Unified Protocol for Transdiagnostic Treatment on Improving Symptoms and Psychological and Neuropsychological Indices in Adults with Attention-Deficit/Hyperactivity Disorder Comorbid with other Emotional Disorders: a Clinical Trial Study
Determining the effectiveness of Unified Protocol for transdiagnostic treatment on improving symptoms and psychological and neuropsychological indicators in adults with attention-deficit/hyperactivity disorder (ADHD) comorbid with other emotional disorders.
Design
A clinical trial with one waitlist group and one experimental group is designed as a double-blind, randomized study using the minimization method, with a sample size of 34 participants.
Settings and conduct
The allocation of participants will be carried out by a person other than the therapist. The minimization method and coin toss will be used for participant allocation. Referrals to the treatment and waitlist groups will be made by the Counseling Center University of Kurdistan and mental health specialists.
Participants/Inclusion and exclusion criteria
Inclusion criteria: meeting the diagnostic criteria for adult attention-deficit/hyperactivity disorder (ADHD) and a comorbid emotional disorder, consent to participate in the study, and being at least 18 years old.
Exclusion criteria: receiving any other psychological treatment, having any personality disorder or being diagnosed with any psychiatric disorder (except for emotional disorders), substance abuse and use of medication related to the disorder, and being absent from more than two therapy sessions.
Intervention groups
Adults with attention-deficit/hyperactivity disorder (ADHD) accompanied by emotional disorders will be randomly assigned to two groups: a treatment group and a waitlist control group. The treatment consists of up to 12 sessions, each lasting 45 minutes, targeting emotional experiences. The waitlist group will receive a similar treatment after the study concludes.
Main outcome variables
Adult ADHD؛ Depression and Anxiety؛ Difficulty in Emotion Regulation؛ Frustration Intolerance؛ Anxiety Sensitivity؛ Inhibition؛ Persistent Inattention؛ Risky Decision-Making
General information
Reason for update
Acronym
UP
IRCT registration information
IRCT registration number:IRCT20250522065850N1
Registration date:2025-06-11, 1404/03/21
Registration timing:prospective
Last update:2025-06-11, 1404/03/21
Update count:0
Registration date
2025-06-11, 1404/03/21
Registrant information
Name
Maryam Khazaeisoltanabadi
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 83 4816 2126
Email address
maryam.khazaei@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-15, 1404/03/25
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of the Unified Protocol for Transdiagnostic Treatment on Improving Symptoms and Psychological and Neuropsychological Indices in Adults with Attention-Deficit/Hyperactivity Disorder Comorbid with other Emotional Disorders: a Clinical Trial Study
Public title
The Effectiveness of Unified Protocol for Transdiagnostic Treatment in adults with attention-deficit/hyperactivity disorder comorbid with other emotional disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria for Adult ADHD and a comorbid emotional disorder
Age range of 18 to 35 years
Full consent to participate in the research
Not receiving other therapeutic interventions concurrently with the present study
Exclusion criteria:
The presence of other psychological disorders and personality disorders except for the mentioned emotional disorders
Absence from more than two therapy sessions
Having a history of substance and psychotropic drug abuse
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
After adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and emotional disorders are selected based on the inclusion and exclusion criteria, they will be assigned to the treatment and waitlist groups using the minimization method. The purpose of this method is to control for the gender variable. For example, if the first participant is female, she will be assigned to group one. If the second participant is male, he will also be assigned to group one. If the third participant is female, she will be assigned to group two, and the remaining participants will be allocated in the same way, ensuring that gender is balanced across the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
A clinical interview will be conducted by a clinical specialist to assess the inclusion and exclusion criteria. After that, participants will be randomly assigned to the treatment group and the waitlist group. The allocation of participants will be carried out by someone other than the therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research
Street address
University of Kurdistan, Organizational Central Building, Third Floor, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R.
The ADHD score on the Adult ADHD Self-Report Scale (ASRS).
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Adult ADHD Self-Report Scale (ASRS)
2
Description
Depression score on the Beck Depression Inventory (BDI_II)
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Beck Depression Inventory (BDI_II)
3
Description
The anxiety score in the Beck Anxiety Inventory.
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Beck Anxiety Inventory - BAI
4
Description
Frustration tolerance score on the Harrington Frustration Discomfort Scale.
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Harrington Frustration Discomfort Scale
5
Description
Anxiety Sensitivity score in the Anxiety Sensitivity Index (ASI) questionnaire
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Anxiety Sensitivity score in the Anxiety Sensitivity Index (ASI) questionnaire
6
Description
Emotion Regulation score on the Emotion Regulation Questionnaire (ERQ) by Gross.
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Emotion Regulation Questionnaire (ERQ) by Gross
7
Description
Response inhibition score on the Go/No-Go task
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Go/No-Go task
8
Description
Risky decision-making score in the Iowa Gambling Task
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Iowa Gambling Task
9
Description
Sustained attention score in the Continuous Performance Test (CPT)
Timepoint
Before treatment; after treatment; one months after the completion of treatment.
Method of measurement
Continuous Performance Test (CPT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Unified Protocol for Transdiagnostic Treatment. The unified protocol for transdiagnostic treatment for emotional disorders consists of up to 12 sessions of 45 minutes each. This treatment targets emotional experiences by fostering emotional awareness and cognitive flexibility; identifying emotion-driven behaviors and replacing them with adaptive behaviors; recognizing and preventing emotional avoidance; increasing awareness of and exposure to bodily sensations; and modulating and confronting emotions in context.
Category
Treatment - Other
2
Description
Control group: The waitlist group will receive the unified protocol for transdiagnostic treatment. After the intervention group's follow-up sessions are completed, the unified protocol for transdiagnostic treatment, similar to that of the first intervention group, will be administered to the waitlist group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Kurdistan
Full name of responsible person
Farzad Nasiri
Street address
University of Kurdistan, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
f.nasiri@uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Ali Akbar Mozafari
Street address
University of Kurdistan, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3362 7722
Email
a.mozafari@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kurdistan
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
The University of Kurdistan
Full name of responsible person
Maryam Khazaei Soltanabadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Enghelab Blvd
City
Kangavar
Province
Kermanshah
Postal code
6741713337
Phone
+98 83 4816 2126
Email
maryam.khazaei@uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Farzad Nasiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4604
Email
f.nasiri@uok.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Maryam Khazaei Soltanabadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Enghelab Blvd
City
Kangavar
Province
Kermanshah
Postal code
6741713337
Phone
+98 83 4816 2126
Email
maryam.khazaei@uok.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
A portion of the data includes information related to the primary outcome that can be shared.
When the data will become available and for how long
The start of access will be one year after the publication of the results.
To whom data/document is available
The data will be accessible only to researchers employed at academic institutions.
Under which criteria data/document could be used
Requests to use the data are only permitted for use in cross-cultural reviews or meta-analyses.
From where data/document is obtainable
To obtain the documentation, they can contact via email at f.nasiri@uok.ac.ir.
What processes are involved for a request to access data/document
Data information will be provided to individuals via email or mail after the request has been evaluated.