Blended Unified Protocol for Emotional Disorders in Primary Care

February 19, 2026 updated by: Merve Demir Budakçıgil, Aydin Adnan Menderes University

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:

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blended UP
Behavioral: Unified Protocol
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.
Active Comparator: Face-to-Face UP
Behavioral: Unified Protocol
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.
No Intervention: Wait-list Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-treatment (Week 10)
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.
Post-treatment (Week 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score
Time Frame: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up
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.
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
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.
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
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.
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
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.
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
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.
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)
Used to assess the quality of the therapeutic alliance. Higher scores indicate a stronger therapeutic bond.
Post-treatment (Week 10)
System Usability Scale (SUS) Score (Note: Only for Blended Group)
Time Frame: Post-treatment (Week 10)
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.
Post-treatment (Week 10)
App Engagement: Duration of Usage (Note: Only for Blended Group)
Time Frame: Through the intervention period (Up to Week 10)
Objective usage data generated by the smartphone application logs to assess adherence. This measure reports the total duration of application usage.
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)
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.
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)
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.
Through the intervention period (Up to Week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-10
  • 124R124 (Other Grant/Funding Number: TÜBİTAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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