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NCT Number: NCT07432906

Blended Unified Protocol for Emotional Disorders in Primary Care

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.

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Key information

Conditions

Emotional Disorders Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Demir Budakçıgil, PhD Candidate

CONTACT

[email protected]

+905078437959

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Feasibility and Preliminary Efficacy of the Unified Protocol in a Blended Format for Emotional Disorders in Primary Care: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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