Blended Unified Protocol for Emotional Disorders in Primary Care

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.

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).