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Transdiagnostic Treatment for Emotional Disorders (UP)

Primary Purpose

Depressive Symptoms, Anxiety, Emotional Problem

Status
Completed
Phase
Not Applicable
Locations
Afghanistan
Study Type
Interventional
Intervention
UP
Treatment as usual
Sponsored by
Mohamad hasan yousefi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Internet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exprimental

Treatment as usual

Arm Description

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)

Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares

Outcomes

Primary Outcome Measures

Beck anxiety inventory
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
Beck anxiety inventory
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
Beck anxiety inventory
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
Overall Anxiety Severity and Impairment Scale (OASIS)
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.
Overall Depression Severity and Impairment Scale (ODSIS
.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.
Emotional style questionnaire
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.
Emotional style questionnaire
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.
Emotional style questionnaire
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.
Difficulties in Emotion Regulation Scale (DERS-16)
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.
Difficulties in Emotion Regulation Scale (DERS-16)
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.
Difficulties in Emotion Regulation Scale (DERS-16)
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.

Secondary Outcome Measures

The Positive and Negative Affect Schedule or (PANAS)
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).
The Positive and Negative Affect Schedule or (PANAS)
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).

Full Information

First Posted
July 16, 2020
Last Updated
March 7, 2022
Sponsor
Mohamad hasan yousefi
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1. Study Identification

Unique Protocol Identification Number
NCT04498949
Brief Title
Transdiagnostic Treatment for Emotional Disorders
Acronym
UP
Official Title
Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamad hasan yousefi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 people.postsecondary 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Emotional Problem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exprimental
Arm Type
Experimental
Arm Description
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)
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares
Intervention Type
Behavioral
Intervention Name(s)
UP
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
Diagnostic test. Psychoeducation Supoortive care
Primary Outcome Measure Information:
Title
Beck anxiety inventory
Description
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
Time Frame
Baseline
Title
Beck anxiety inventory
Description
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
Time Frame
12 weeks after basel8ne
Title
Beck anxiety inventory
Description
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
Time Frame
Three month follow up
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
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.
Time Frame
12 weeks after baseline
Title
Overall Depression Severity and Impairment Scale (ODSIS
Description
.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.
Time Frame
Baseline
Title
Emotional style questionnaire
Description
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.
Time Frame
baseline
Title
Emotional style questionnaire
Description
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.
Time Frame
12 weeks after baseline
Title
Emotional style questionnaire
Description
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.
Time Frame
Three month follow up
Title
Difficulties in Emotion Regulation Scale (DERS-16)
Description
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.
Time Frame
Baseline, :
Title
Difficulties in Emotion Regulation Scale (DERS-16)
Description
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.
Time Frame
12 weeks after baseline
Title
Difficulties in Emotion Regulation Scale (DERS-16)
Description
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.
Time Frame
Three month follow up
Secondary Outcome Measure Information:
Title
The Positive and Negative Affect Schedule or (PANAS)
Description
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).
Time Frame
12 weeks after baseline
Title
The Positive and Negative Affect Schedule or (PANAS)
Description
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).
Time Frame
Three months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Internet
City
Bamyan
Country
Afghanistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Between July 2022 to December 2022
IPD Sharing Access Criteria
Resonable request via academic email

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Transdiagnostic Treatment for Emotional Disorders

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