Blended Unified Protocol for Emotional Disorders in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAydin Adnan Menderes University
About this trial
The goal of this clinical trial is to learn if a "blended" therapy format (combining face-to-face therapy sessions with a smartphone app) works to treat emotional disorders, such as depression and anxiety, in adults. It will also see if this blended format is feasible and acceptable for patients in primary care settings.
The main questions it aims to answer are:
Does the blended therapy format reduce symptoms of depression and anxiety?
Is the blended format as effective as standard face-to-face therapy?
Do participants find the smartphone app easy and helpful to use?
Researchers will compare the blended therapy group to a standard face-to-face therapy group and a wait-list control group to see if the blended approach works well.
Participants will:
Attend therapy sessions based on the Unified Protocol (a type of cognitive-behavioral therapy) for about 10 weeks.
Use a smartphone app to complete exercises and track their emotions (if assigned to the blended group).
Answer questionnaires about their symptoms and quality of life at the beginning, at the end of treatment, and 3 months later.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 65 years.
Scoring 8 or higher on the Overall Anxiety Severity and Impairment Scale (OASIS) OR the Overall Depression Severity and Impairment Scale (ODSIS), indicating clinical severity.
Ownership of a smartphone (Android or iOS) and ability to use mobile applications.
Literacy in Turkish.
Disqualifiers
Diagnosis of bipolar disorder, psychotic disorder, or antisocial personality disorder (assessed via MINI 5.0.0).
High risk of suicide (assessed via MINI 5.0.0).
Cognitive impairment (Score < 21 on the Montreal Cognitive Assessment - MoCA).
Current substance alcohol or drug dependence.
Trial design
Design model
Parallel
Treatments tested in this trial
Unified Protocol
BehavioralA transdiagnostic cognitive-behavioral intervention consisting of 8 modules targeting emotion regulation mechanisms. It includes psychoeducation, mindful emotion awareness, cognitive flexibility, countering emotional behaviors, and exposure exercises.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Blended UPExperimental treatment 1 intervention
Group B: Face-to-Face UPActive comparator 1 intervention
Group C: Wait-list ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility (Recruitment and Retention Rates)
Feasibility will be evaluated by tracking the recruitment rate (meeting the target of N=45 within the planned timeframe) and the retention rate. A success criterion is defined as ≥80% of participants in the intervention groups completing the study protocol.
Time frame
Post-treatment (Week 10)2
Acceptability (Participant Satisfaction)
Assessed using items adapted from Branquinho et al. regarding the perceived usefulness of the intervention and preference for the format. Two key questions are asked: (1) Perceived usefulness (Yes/No) and (2) Preference for this type of treatment (rated on a 4-point scale from "No, I would refuse" to "Yes, I would prefer it"). Qualitative feedback on advantages/disadvantages is also collected.
Time frame
Post-treatment (Week 10)Secondary outcomes
1
Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score
The OASIS is a 5-item self-report measure designed to assess the frequency and intensity of anxiety symptoms, as well as avoidance and functional impairment related to anxiety. Items are rated on a 0-4 scale. The total score ranges from 0 to 20, with higher scores indicating greater anxiety severity and impairment.
Time frame
Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up2
Change in Overall Depression Severity and Impairment Scale (ODSIS) Score
The ODSIS is a 5-item instrument used to evaluate the frequency and severity of depressive symptoms and the resulting functional impairment. Items are rated on a 0-4 scale. The total score ranges from 0 to 20, with higher scores indicating greater depression severity and impairment.
Time frame
Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up3
Change in Multidimensional Emotional Disorder Inventory (MEDI) Score
A 49-item self-report inventory assessing 9 transdiagnostic dimensions of emotional disorders (neurotic temperament, positive temperament, depressed mood, autonomic arousal, somatic anxiety, social anxiety, intrusive thoughts, traumatic re-experiencing, and avoidance). Higher scores indicate higher levels of the respective dimension.
Time frame
Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up4
Change in Difficulties in Emotion Regulation Scale (DERS) Score
A 36-item self-report measure assessing emotion regulation deficits. It includes subscales like nonacceptance, goals, impulse, awareness, strategies, and clarity. Higher total scores indicate greater difficulty in emotion regulation.
Time frame
Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-upLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Aydin Adnan Menderes University Status unavailable Aydın, ManisaTurkey (Türkiye)
Sponsors and contacts
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Source ClinicalTrials.gov
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