Depressive SymptomsUPNCT04498949
Transdiagnostic Treatment for Emotional Disorders
A study testing UP and Treatment as usual in people with Depressive Symptoms and Anxiety, run by Mohamad hasan yousefi at 1 site in Afghanistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depressive Symptoms, Anxiety, Emotional Problem
- What is being tested?
- UP and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteAfghanistan
- Study dates
- 15 Aug 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial
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.
Read the 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
- 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
- Conditions
- Depressive Symptoms, Anxiety, Emotional Problem
- Being tested
- UP, Treatment as usual
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPBehavioural
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 usualOther
Also called TAU
Diagnostic test. Psychoeducation Supoortive care
| Study group | Role | What they receive |
|---|---|---|
| Exprimental | Experimental | 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) Receives: Behavioral: UP |
| Treatment as usual | Active comparator | Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: 12 weeks after basel8ne
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
Measured: Three month follow up
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.
Measured: 12 weeks after baseline
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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: 12 weeks after baseline
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.
Measured: Three month follow up
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.
Measured: Baseline, :
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.
Measured: 12 weeks after baseline
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.
Measured: Three month follow up
Secondary outcomes (2)
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).
Measured: 12 weeks after baseline
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).
Measured: Three months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start15 Aug 2020
- Primary completion30 Nov 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamad hasan yousefi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamad hasan yousefi, Bamyan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498949
- Sponsor's protocol ID
- Unified Protocol
- Acronym
- UP
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04498949
- Acronym / sponsor ID
- UP / Unified Protocol
- Conditions
- Depressive Symptoms, Anxiety, Emotional Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Mohamad hasan yousefiUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exprimental | Experimental | Behavioral: UPThe 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 | Active comparator | Other: Treatment as usualTreatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPThe 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) | Behavioural | Exprimental |
| Treatment as usualAlso: TAUDiagnostic test. Psychoeducation Supoortive care | Other | Treatment as usual |
Primary outcome
Beck anxiety inventory
Time frame: Baseline
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
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
Beck anxiety inventory
Time frame: Three month follow up
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)
Time frame: 12 weeks after baseline
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
Time frame: Baseline
.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
Time frame: baseline
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
Time frame: 12 weeks after baseline
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
Time frame: Three month follow up
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)
Time frame: Baseline, :
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)
Time frame: 12 weeks after baseline
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)
Time frame: Three month follow up
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.
2 secondary outcomes
The Positive and Negative Affect Schedule or (PANAS)
Time frame: 12 weeks after baseline
The Positive and Negative Affect Schedule or (PANAS)
Time frame: Three months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UP and Treatment as usual in people with Depressive Symptoms and Anxiety, run by Mohamad hasan yousefi at 1 site in Afghanistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Afghanistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck anxiety inventory (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.