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Not yet recruiting NCT07432906

Blended Unified Protocol for Emotional Disorders in Primary Care

No phase Interventional Emotional Disorders Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unified Protocol.
Who it may be relevant to
Registry conditions: Emotional Disorders, Anxiety, Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility (Recruitment and Retention Rates) [Time frame: Post-treatment (Week 10)]
  • Acceptability (Participant Satisfaction) [Time frame: Post-treatment (Week 10)]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Aydin Adnan Menderes University — Aydın

Identifiers

NCT: NCT07432906 · 11-10 · 124R124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗