Emotional DisordersNCT07432906
Blended Unified Protocol for Emotional Disorders in Primary Care
A study testing Unified Protocol in people with Emotional Disorders and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Disorders, Anxiety, Depression
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willingness to participate in the study and sign the informed consent form.
Who cannot join
- 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.
- Currently receiving another psychological treatment (psychotherapy).
- Changes in psychopharmacological treatment (medication dosage or type) within the last 3 months (participants must be on a stable dose).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University
Aydın, Manisa
Merve Demir Budakçıgil, +905078437959, merve.demir@adu.edu.tr
About this study
Official title: Feasibility and Preliminary Efficacy of the Unified Protocol in a Blended Format for Emotional Disorders in Primary Care: A Pilot Randomized Controlled 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:
Read more
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.
- Conditions
- Emotional Disorders, Anxiety, Depression
- Being tested
- Unified Protocol
- Keywords
- Unified Protocol, Blended care, Primary care, Transdiagnostic
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Blended UP | Experimental | Not described Receives: Behavioral: Unified Protocol |
| Face-to-Face UP | Active comparator | Not described Receives: Behavioral: Unified Protocol |
| Wait-list Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (Week 10)
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.
Measured: Post-treatment (Week 10)
Secondary outcomes (10)
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.
Measured: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
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.
Measured: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
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.
Measured: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
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.
Measured: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Change in Short Form-12 (SF-12) Quality of Life Score
A 12-item scale measuring functional health and well-being. It yields two summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Working Alliance Inventory-Short Revised (WAI-SR) Score
Used to assess the quality of the therapeutic alliance. Higher scores indicate a stronger therapeutic bond.
Measured: Post-treatment (Week 10)
System Usability Scale (SUS) Score (Note: Only for Blended Group)
A 10-item questionnaire used to measure the usability of the smartphone application. The total score ranges from 0 to 100, with higher scores indicating better usability.
Measured: Post-treatment (Week 10)
App Engagement: Duration of Usage (Note: Only for Blended Group)
Objective usage data generated by the smartphone application logs to assess adherence. This measure reports the total duration of application usage.
Measured: Through the intervention period (Up to Week 10)
App Engagement: Videos Viewed (Note: Only for Blended Group)
Objective usage data generated by the smartphone application logs to assess adherence. This measure reports the total number of psychoeducational videos viewed by the participant.
Measured: Through the intervention period (Up to Week 10)
App Engagement: Completed Exercises (Note: Only for Blended Group)
Objective usage data generated by the smartphone application logs to assess adherence. This measure reports the total volume (count) of in-app exercises completed by the participant.
Measured: Through the intervention period (Up to Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisordersStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Demir Budakçıgil, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432906
- Sponsor's protocol ID
- 11-10
- Other IDs
- 124R124
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of the Unified Protocol in a Blended Format for Emotional Disorders in Primary Care: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07432906
- Acronym / sponsor ID
- 11-10
- Conditions
- Emotional Disorders, Anxiety, Depression
- Keywords
- Unified Protocol, Blended care, Primary care, Transdiagnostic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blended UP | Experimental | Behavioral: Unified Protocol |
| Face-to-Face UP | Active comparator | Behavioral: Unified Protocol |
| Wait-list Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Willingness to participate in the study and sign the informed consent form.
Key exclusion criteria (6 listed)
- 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.
- Currently receiving another psychological treatment (psychotherapy).
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 |
|---|---|---|
| Unified ProtocolA 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. | Behavioural | Blended UP, Face-to-Face UP |
Primary outcome
Feasibility (Recruitment and Retention Rates)
Time frame: Post-treatment (Week 10)
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.
Acceptability (Participant Satisfaction)
Time frame: Post-treatment (Week 10)
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.
10 secondary outcomes
Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score
Time frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Change in Overall Depression Severity and Impairment Scale (ODSIS) Score
Time frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Change in Multidimensional Emotional Disorder Inventory (MEDI) Score
Time frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Change in Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Change in Short Form-12 (SF-12) Quality of Life Score
Time frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
Working Alliance Inventory-Short Revised (WAI-SR) Score
Time frame: Post-treatment (Week 10)
System Usability Scale (SUS) Score (Note: Only for Blended Group)
Time frame: Post-treatment (Week 10)
App Engagement: Duration of Usage (Note: Only for Blended Group)
Time frame: Through the intervention period (Up to Week 10)
App Engagement: Videos Viewed (Note: Only for Blended Group)
Time frame: Through the intervention period (Up to Week 10)
App Engagement: Completed Exercises (Note: Only for Blended Group)
Time frame: Through the intervention period (Up to Week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Emotional Disorders and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Demir Budakçıgil, PhD Candidate (+905078437959, merve.demir@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Recruitment and Retention Rates) (time frame: Post-treatment (Week 10)). The study lists 2 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 25 Feb 2026.