Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498949
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2020-07-16
Brief Title:
Transdiagnostic Treatment for Emotional Disorders
Sponsor:
Mohamad hasan yousefi
Organization:
Bamyan University
Study Overview
Official Title:
Transdiagnostic Treatment for University Students at Risk of Emotional Disorders a Web Based Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UP
Brief Summary:
Background and study aims Depression is more prevalent in younger populations The age of first onset of depression has become younger yet many adolescents with depressive symptoms remain untreated Rates of anxiety and depression are increasing among children and young peoplepostsecondary education also represents a peak onset period for the occurrence of mental disorders It is estimated that 12-46 of all university students are affected by mental health disorders in any given year Who can participate Afghan students over 18 years old fluent in Persian or Pashto and access to an internet connection What does the study involve Participants will be randomly allocated to receive training in skills and coping strategies which are useful in stressful conditions
Detailed Description:
Condition Depressive symptoms anxiety symptom emotional problems Interventions Participants in experimental group Receive 12 weeks training according to the guideline below Participants in control Receive treatment as usual also the experts will respond to their questions The unified protocol can track its basis from cognitive-behavioral therapy approaches As in the traditional CBT approaches the unified protocol has several modules whose base is the emotions The modules focus on increasing awareness of interaction and the function of the model of emotion components which include thoughts physical sensations and behaviors The final bit of the unified protocol is to change the components to a present moment awareness The unified protocol is used to treat different emotional disorders unlike the traditional CBT approaches This is done by targeting the underlying mechanisms that form part of all emotional disorders The 5 core skills above are delivered to patients through five core modules Before the key modules there are 2 modules for introduction and learning about emotions After the 5 core modules there is a module for treatment progress appraisal and making plans to prevent relapse
The unified protocol modules are as follows
Module 1 Setting the treatment goals and motivation augmentation Module 2 Using psychoeducation to learn the function of emotions and their development Module 3 Mindful present-focused and non-judgmental emotional awareness- Core module Module 4 Cognitive flexibility- Core module Module 5 Identifying and countering emotional avoidance behaviors- core module Module 6 Increasing awareness and confronting physical sensations interoceptive sensitivity- core module Module 7 Both situational and interoceptive emotion-focused exposures- Core module Module 8 Recognizing accomplishments and looking to the future relapse prevention Primary outcome measure
At baseline and 12 weeks
1 Anxiety measured using the Beck Anxiety Inventory BAI
2 Depression measured using the Beck Depression Inventory BDI-II Secondary outcome measures
At baseline and 12 weeks
1 Mental health measured using
11 Overall Anxiety Severity and Impairment Scale OASIS 12 Overall Depression Severity and Impairment Scale ODSIS 13 Positive and Negative Affect Scale PANAS
2 Quality of life measured using the qolwbref questionnaire Eligibility Participant inclusion criteria
1 18 years or older 2 Ability to understand and read Persian or Pashto 3 Access to Internet at home and having an email address 4 Meeting the DSM-IV diagnostic criteria for ED MDD DD MDNOS PD A SAD GAD ADNOS OCD 5 Providing written informed consent
The unified protocol modules are as follows
Module 1 Setting the treatment goals and motivation augmentation Module 2 Using psychoeducation to learn the function of emotions and their development Module 3 Mindful present-focused and non-judgmental emotional awareness- Core module Module 4 Cognitive flexibility- Core module Module 5 Identifying and countering emotional avoidance behaviors- core module Module 6 Increasing awareness and confronting physical sensations interoceptive sensitivity- core module Module 7 Both situational and interoceptive emotion-focused exposures- Core module Module 8 Recognizing accomplishments and looking to the future relapse prevention Primary outcome measure
At baseline and 12 weeks
1 Anxiety measured using the Beck Anxiety Inventory BAI
2 Depression measured using the Beck Depression Inventory BDI-II Secondary outcome measures
At baseline and 12 weeks
1 Mental health measured using
11 Overall Anxiety Severity and Impairment Scale OASIS 12 Overall Depression Severity and Impairment Scale ODSIS 13 Positive and Negative Affect Scale PANAS
2 Quality of life measured using the qolwbref questionnaire Eligibility Participant inclusion criteria
1 18 years or older 2 Ability to understand and read Persian or Pashto 3 Access to Internet at home and having an email address 4 Meeting the DSM-IV diagnostic criteria for ED MDD DD MDNOS PD A SAD GAD ADNOS OCD 5 Providing written informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None