Clinical trial NCT04498949: Transdiagnostic Treatment for Emotional Disorders
Official title: Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Emotional Problem
Lead sponsor: Bamyan University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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:

   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)
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

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

Primary outcomes:
measure: Beck anxiety inventory
timeFrame: Baseline
measure: Beck anxiety inventory
timeFrame: 12 weeks after basel8ne
measure: Beck anxiety inventory
timeFrame: Three month follow up
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: 12 weeks after baseline
measure: Overall Depression Severity and Impairment Scale (ODSIS
timeFrame: Baseline
measure: Emotional style questionnaire
timeFrame: baseline
measure: Emotional style questionnaire
timeFrame: 12 weeks after baseline
measure: Emotional style questionnaire
timeFrame: Three month follow up
measure: Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: Baseline, :
measure: Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: 12 weeks after baseline
measure: Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: Three month follow up
Secondary outcomes:
measure: The Positive and Negative Affect Schedule or (PANAS)
timeFrame: 12 weeks after baseline
measure: The Positive and Negative Affect Schedule or (PANAS)
timeFrame: Three months follow up
Other outcomes:
Locations:
city: Bamyan
country: Afghanistan
facility: Internet
Study officials:
References: