- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04498949
Transdiagnostic Treatment for Emotional Disorders (UP)
Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Anxiety measured using the Beck Anxiety Inventory (BAI)
- Depression measured using the Beck Depression Inventory (BDI-II) Secondary outcome measures
At baseline and 12 weeks:
Mental health measured using:
1.1. Overall Anxiety Severity and Impairment Scale (OASIS) 1.2. Overall Depression Severity and Impairment Scale (ODSIS) 1.3. Positive and Negative Affect Scale (PANAS)
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bamyan, Afghanistan
- Internet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Ability to understand and read Persian or Pashto
- Access to Internet at home and having an email address
- Meeting the DSM-IV diagnostic criteria for ED (MDD, DD, MDNOS, PD, A, SAD, GAD, ADNOS, OCD)
Exclusion Criteria:
- Suffering from a severe mental disorder (schizophrenia, bipolar disorder, and alcohol and/or substance dependence disorder)
- The presence of a high risk of suicide
- other chronic or Medical disease/condition that prevents the participant
- receiving another psychological treatment during the last six month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exprimental
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) |
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) |
Active Comparator: Treatment as usual
Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares
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Diagnostic test.
Psychoeducation Supoortive care
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck anxiety inventory
Time Frame: Baseline
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This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week.
Each item is rated from 0 to 3 (i.e.
not at all, mildly, moderately, severely), added together to obtain a maximum score of 63.
The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity .
Cronbach's alpha for the BAI in the present study was excellent
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Baseline
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Beck anxiety inventory
Time Frame: 12 weeks after basel8ne
|
This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week.
Each item is rated from 0 to 3 (i.e.
not at all, mildly, moderately, severely), added together to obtain a maximum score of 63.
The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity .
Cronbach's alpha for the BAI in the present study was excellent
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12 weeks after basel8ne
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Beck anxiety inventory
Time Frame: Three month follow up
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This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week.
Each item is rated from 0 to 3 (i.e.
not at all, mildly, moderately, severely), added together to obtain a maximum score of 63.
The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity .
Cronbach's alpha for the BAI in the present study was excellent
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Three month follow up
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Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: 12 weeks after baseline
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he OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e.
school, work, home, or social impairment), and behavioral avoidance.
Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week.
Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20.
Previous studies have shown high internal consistency.
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12 weeks after baseline
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Overall Depression Severity and Impairment Scale (ODSIS
Time Frame: Baseline
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.The Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014) is a 5-item self-report measure that was designed for assessing the frequency and intensity of depression symptoms, the functional impairment related to these depressive symptoms, as well as behavioral avoidance across emotional disorders.
Each item of the ODSIS instructs respondents to endorse one of five responses that best describes their experiences over the past week.
Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20.
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Baseline
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Emotional style questionnaire
Time Frame: baseline
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Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale.
Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always).
Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
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baseline
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Emotional style questionnaire
Time Frame: 12 weeks after baseline
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Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale.
Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always).
Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
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12 weeks after baseline
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Emotional style questionnaire
Time Frame: Three month follow up
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Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale.
Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always).
Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
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Three month follow up
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Difficulties in Emotion Regulation Scale (DERS-16)
Time Frame: Baseline, :
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Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items).
As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always).
Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
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Baseline, :
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Difficulties in Emotion Regulation Scale (DERS-16)
Time Frame: 12 weeks after baseline
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Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items).
As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always).
Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
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12 weeks after baseline
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Difficulties in Emotion Regulation Scale (DERS-16)
Time Frame: Three month follow up
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Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items).
As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always).
Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
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Three month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Positive and Negative Affect Schedule or (PANAS)
Time Frame: 12 weeks after baseline
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The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect.
The scale is comprised of several words that describe different emotions and feelings.
(Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
(Watson, D., Clark, L. A., & Tellegan, A., 1988).
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12 weeks after baseline
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The Positive and Negative Affect Schedule or (PANAS)
Time Frame: Three months follow up
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The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect.
The scale is comprised of several words that describe different emotions and feelings.
(Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
(Watson, D., Clark, L. A., & Tellegan, A., 1988).
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Three months follow up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Unified Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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