A Novel Adaptation of the Unified Protocol (UP) as a Transdiagnostic Intervention for Emotional Disorders in Addictive Behaviors

Official title

Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors

Overview

This study aims to pilot a psychological intervention protocol designed for individuals who use substances and who experience difficulties in emotion regulation. Emotion regulation refers to a person's ability to understand, manage, and respond to emotions in a healthy way. When these skills are impaired, individuals may develop emotional disorders (such as anxiety or depression) and addictive behaviors. For this reason, improving emotion regulation is considered a key component in addiction treatment.

Detailed description

The goal is to implement and evaluate a structured intervention program that helps people undergoing inpatient or outpatient treatment for substance use disorders to:

1. Better understand their emotions 2. Develop healthier emotion regulation strategies 3. Reduce emotional distress 4. Decrease addictive behaviors

The protocol is based on:

1. The contextual model, which understands emotional problems within each person's life context. 2. Transdiagnostic approaches, which target psychological processes that are common across different mental health disorders. 3. An adaptation of the Unified Protocol (UP) developed by Dr. David Barlow, an evidence-based treatment for emotional disorders. 4. Additional third wave psychological treatment procedures that have demonstrated effectiveness in improving emotion regulation.

Interventions

• Behavioral Transdiagnostic cognitive-behavioral therapy
  This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)
• Behavioral Treatment as usual
  This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.

Primary outcome measures

• Anxiety severity and related functional impairment measured using the Overall Anxiety Severity and Impairment Scale (OASIS) [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Positive Emotion Dysregulation [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Negative emotion dysregulation [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention.]
• Experiential avoidance [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Present-Moment Awareness [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Negative automatic thoughts related to depression [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]
• Depressive symptoms [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention.]
• Anxiety-Related Cognitive Fusion [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]

Secondary outcome measures (1)

• Substance use abstinence [Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention]

Eligibility criteria

Inclusion criteria

• Inclusion Criteria:

• Currently receiving treatment for substance use in either an inpatient or outpatient setting.
• Meet DSM-5 criteria for Major Depressive Disorder or Anxiety Disorder (i.e., Panic Disorder, Generalized Anxiety Disorder, Agoraphobia, Social Anxiety Disorder).

Exclusion criteria

• Not currently engaged in inpatient or outpatient substance use treatment.
• Failure to meet diagnostic criteria for depression or any of the specified anxiety disorders within the past 12 months.
• Severe cognitive impairment or acute psychiatric mental health disorders (i.e., psychosis, bipolar disorder) that would preclude participation in the assessment and treatment.
• Active suicidal behavior

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

Spain · 1 center

• University of Oviedo — Oviedo

Publications

• Osma J, Sanchez-Albentosa M, Prieto-Rollan I, Fadrique-Jimenez A, Navarro-Haro MV, Peris-Baquero O. Cost-effectiveness and acceptability study of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services of the Spanish National Health System: a study protocol. BMC Prim Care. 2026 May 2;27(1):243. doi: 10.1186/s12875-026-03347-w. PMID 42067774
• Meyer EC, Roth SG, Coe E, Taylor DJ, Gulliver SB. Pilot outcomes and exploration of treatment mechanisms using a culturally adapted version of the unified protocol for transdiagnostic treatment of emotional disorders to improve mental health symptoms, alcohol misuse, functional outcomes, and sleep quality in emergency responders. Front Health Serv. 2025 Jun 16;5:1452976. doi: 10.3389/frhs.2025.145 PMID 40589783
• Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9. PMID 34098412

Identifiers

NCT: NCT07738081 · ceimpa. 2026.126 · D

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗