1- Assessing the effectiveness of Unified Protocol for transdiagnostic treatment of emotional disorders (UP) on students' procrastination
2- Assessing the mediators of the reduction of procrastination in UP
Design
A clinical trial with a control group and two intervention groups, with parallel groups with 45 participants randomly assigned to each of the groups, by block randomization method using www.randomaization.com.
Settings and conduct
Volunteers will be completing the the revised version of the symptom checklist (SCL-90-R) and Pure Procrastination Scale (PPS), 45 of those who qualify the research criteria will be recruited. They will be divided into three groups using random assignment. The UP group has 12 sessions, the CBT group has 10 sessions, and the control group does not receive any intervention. The outcome measures will be completed before, in the middle, after and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- Bachelor and General Medical students who have completed the first year and students of other degrees,
2- severe procrastination (75% of total score in pure procrastination scale);
Exclusion Criteria:
1- Global Severity Index (GSI) higher than 1 in the SCL-90-R Scale.
Intervention groups
The Unified Protocol for transdiagnostic treatment of emotional disorders (UP)
The Cognitive Behavioral Therapy group (CBT)
The control group
The effectiveness and mediating factors in unified transdiagnostic treatment on students’ procrastination
Public title
The effectiveness of transdiagnostic treatment on procrastination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bachelor and General Medical students who have completed the first year (first semester students are not familiar with their performance style for university assignments yet) and students of other degrees
severe procrastination (75% of total score in pure procrastination scale)
Exclusion criteria:
score >1 in GSI index of SCL-90-R
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
We are going to use block randomization method . Randomization unit is the person. Making a randomization sequence will be done through the website http://www.randomization.com/.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.634
Health conditions studied
1
Description of health condition studied
Procrastination
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The participants' score in the Intolerance of Uncertainty Scale (IUS)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
Intolerance of Uncertainty Scale (IUS)
2
Description
the participants' score in the Difficulties in Emotion Regulation Scale (DERS)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
Difficulties in Emotion Regulation Scale (DERS)
3
Description
the participants' score in the Acceptance and Action Questionnaire–II (AAQ-II)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
Acceptance and Action Questionnaire–II (AAQ-II)
4
Description
the participants' score in the Anxiety sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
Anxiety sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
5
Description
the participants' score in the Depression sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
Depression sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
6
Description
the participants' score in the Stress sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
Timepoint
before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention.
Method of measurement
the Stress sub-scale of Depression, Anxiety, Stress Scale (DASS-21)
Secondary outcomes
1
Description
the participants' score in the Pure Procrastination Scale (PPS)
Timepoint
Before the intervention. 6th session of the intervention, after completing the intervention, 2 months after the intervention
Method of measurement
Pure Procrastination Scale (PPS)
Intervention groups
1
Description
Intervention group: The Unified transdiagnostic protocol for emotional disorders (UP) introduced by Barlow et al (2010) in Unified Protocol Institute in Boston University, will be used. This protocol is available as a therapist's manual and a workbook for clients. The outline of the material to be presented at each session is presented in the table below: First session: Unified model of psychopathology; motivation enhancementstrategies; treatment goal setting (UP Module 1); Second Session: Psychoeducation on adaptive function of emotions; threecomponentmodel of emotional experiences (UP Module 2); Third Session: Natural course of emotions and role of avoidance; present-focused,nonjudgmental emotion awareness (UP Module 3). Forth Session: Cognitive appraisal; thinking traps and countering questions;downward arrow (UP Module 4). Fifth Session: Identification of emotional avoidance strategies; rationale forreplacing emotion-driven behaviors (EDBs) with incompatiblebehaviors (UP Module 5). Sixth Session: Psychoeducation on interoceptive conditioning; symptom inductiontest; interoceptive exercises (UP Module 6). Seventh to Eleventh Sessions: Exposure rationale; create and review individual hierarchies;situational emotion-focused exposures (UP Module 7). Twelfth Session: Skill review; emphasis on continued implementation of exposures;review of progress and future goals; relapse prevention strategies(UP Module 8).
Category
Treatment - Other
2
Description
Intervention group: Cognitive-behavioral therapy is a kind of psychotherapy that helps patients to understand the thoughts and feelings that affect their behavior. This treatment is generally short-term and can be performed either individually or in groups. It also focuses on helping patients address a specific problem. During the course of treatment, one learns how to identify and modify the patterns of maladaptive or distorted thinking that have a negative effect on his or her behavior. In this study, we are going to use the CBT protocol for procrastination introduced by Rosenthal et al clinical trial in 2015.The therapeutic modules in the CBT treatment group are as follows: 1. An introduction to the current study and basic psychoeducation of CBT and procrastination.2. Information on the etiology and maintenance of procrastination.3. Psychoeducation on goal-setting techniques, avoidance behavior,and behavioral activation.4. Theories of motivation and use of reward systems to facilitate learned industriousness.5. Presentation of ego-depletion, mental fatigue, and their relationship to procrastination.6. The influence of distractions and using stimulus control to increase focused work.7. Different ways of practicing self-assertiveness and becoming better at prioritizing.8. The influence of dysfunctional beliefs and an introduction to performing behavioral experiments.9. Exploration of personal values using value clarification and information on acceptance.10. Information on the abstinence violation effect and the importance of relapse prevention.
Category
Treatment - Other
3
Description
Control group: since the participants are students, there would be no need for theraputic or heath care measures. thus the control group won't recive any kind of intervention or usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Somayeh Zamirinejad
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
http://iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Somayeh Zamirinejad
Position
Doctoral Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Apartment 1, number 36, 9th Daryanno, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1455973463
Phone
+98 21 6650 5019
Fax
Email
somayeh.zamiri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Zamirinejad
Position
Doctoral Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Apartment 1, number 36, 9th Daryanno, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1455973463
Phone
+98 21 6650 5019
Fax
Email
somayeh.zamiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Zamirinejad
Position
Doctoral Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Apartment 1, number 36, 9th Daryanno, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1455973463
Phone
+98 21 6650 5019
Fax
Email
somayeh.zamiri@gmail.com
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The treatment outcomes are assessed through questionnaires and analyzed in a group, so the people will be unidentified. SPSS file will be shared.
When the data will become available and for how long
the access starts 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Since the questionnaires contain the demographic characteristics, consent forms and the participants' signature, and also in some steps, for example, the follow-up the questionnaires will be sent to the participants online, access to each questionnaire will not be possible. But for the SPSS file, researchers will be allowed to have any analyzes that are tailored to their purpose.
From where data/document is obtainable
Requests by email will be answered by Mrs. Somayeh Zamirinejad.
Somayeh.zamiri@gmail.com
What processes are involved for a request to access data/document
Applicants must provide their reason for their request and explain how these data are relevant to their study, and the data will be sent to them in 1 month after we receive the email.