Blended Unified Protocol for Emotional Disorders in Primary Care

NCT07432906 | Not Yet Recruiting

• 2 other identifiers: 11-10124R124
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Emotional Disorders; Anxiety; Depression

Keywords

Unified Protocol; Blended care; Primary care; Transdiagnostic

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post-treatment (Week 10)

Secondary Outcomes (10)

• Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score

  Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up

• Change in Overall Depression Severity and Impairment Scale (ODSIS) Score

  Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up

• Change in Multidimensional Emotional Disorder Inventory (MEDI) Score

  Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up

• Change in Difficulties in Emotion Regulation Scale (DERS) Score

  Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up

• Change in Short Form-12 (SF-12) Quality of Life Score

  Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up

Study Arms (3)

Blended UP

EXPERIMENTAL

Behavioral: Unified Protocol

Face-to-Face UP

ACTIVE COMPARATOR

Behavioral: Unified Protocol

Wait-list Control

NO INTERVENTION

Interventions

Unified Protocol BEHAVIORAL

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.

Blended UP; Face-to-Face UP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University

Aydın, Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Merve Demir Budakçıgil, PhD Candidate

CONTACT

+905078437959; merve.demir@adu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

TU (1)