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

NCT07738081 | Enrolling By Invitation

• 2 other identifiers: ceimpa. 2026.126D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Addictive Behaviors; Emotion Regulation

Keywords

Transdiagnostic; Psychological treatment; Unified Protocol; Addictive Behaviors; Pilot Study

Outcome Measures

Primary Outcomes (9)

• Anxiety severity and related functional impairment measured using the Overall Anxiety Severity and Impairment Scale (OASIS)

  The OASIS (Osma et al., 2019) is a 5 item brief self-report instrument assessing anxiety intensity, frequency, avoidance, and interference. Range: 0-20. Higher scores reflect greater anxiety severity (worse outcome)

  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).

  The ASI-3 (Sandín et al., 2005) is a 16-item self-report instrument that assesses physical, cognitive, and social concerns related to anxiety symptoms. The ASI evaluates three dimensions: somatic sensitivity (fear of physical symptoms of anxiety), cognitive sensitivity (fear of cognitive dyscontrol), and social sensitivity (fear of publicly observable anxiety symptoms). In addition to subscale scores, a total score is calculated, with higher scores indicating greater anxiety sensitivity. Range: 0-64. Higher scores reflect greater anxiety sensitivity (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

• Positive Emotion Dysregulation

  Positive emotion dysregulation will be assessed using the Difficulties in Emotion Regulation Scale - Positive (DERS-P; Weiss et al., 2019). The DERS-P allows to identify difficulties in the modulation, acceptance, and adaptive management of positive emotional states. Higher scores indicate greater difficulties in regulating positive emotions. Range: 13-65. Higher scores reflect greater difficulties regulating positive emotions (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

• Negative emotion dysregulation

  The Spanish DERS-28 ( Hervás \& Jódar, 2008) assesses difficulties in the awareness, understanding, or modulation of emotion. It consists of 28 items with five subscales: non-acceptance of emotional responses, Interference, lack of emotional control, Inattention, and Confusion. Range: 28-140. Higher scores reflect greater difficulty regulating negative emotions (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention.

• Experiential avoidance

  The Brief Experiential Avoidance Questionnaire (BEAQ; Vázquez-Morejón et al., 2019) is a brief self-report questionnaire designed to assess experiential avoidance, defined as the tendency to avoid, suppress, or attempt to control unwanted internal experiences such as thoughts, emotions, and bodily sensations, even when doing so causes behavioral restriction or psychological distress. Higher scores indicate greater levels of experiential avoidance. Range: 15-90. Higher scores reflect greater experiential avoidance (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

• Present-Moment Awareness

  Present-moment awareness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ; Cebolla et al., 2012), a 39-item multifactorial self-report measure designed to assess mindfulness as a dispositional tendency to maintain awareness of present-moment experiences with an attitude of openness and acceptance. The questionnaire comprises five facets: (1) observing internal and external experiences; (2) describing; (3) acting with awareness; (4) nonjudging of inner experience; and (5) nonreactivity to inner experience. Higher scores indicate greater levels of dispositional mindfulness. Range: 39-195. Higher scores reflect greater present-moment awareness (better outcome).

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

• Negative automatic thoughts related to depression

  Negative automatic thoughts related to depression will be assessed using the Automatic Thoughts Questionnaire-8 (ATQ-8; Ruiz et al., 2020). The ATQ-8 is an 8-item self-report questionnaire that measures the presence of recurrent cognitions related to hopelessness, self-criticism, and negative self-evaluation. Range: 8-40. Higher scores reflect higher frequency of negative automatic thoughts (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

• Depressive symptoms

  Depressive symptoms will be assessed using the Overall Depression Severity and Impairment Scale (ODSIS; Osma et al., 2019). The ODSIS consists of 5 items, and a cutoff score of 10 is used to identify clinical cases. Range: 0-20. Higher scores reflect greater depression severity (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention.

• Anxiety-Related Cognitive Fusion

  Anxiety-related cognitive fusion will be assessed using the believability of Anxious Feelings and Thoughts Questionnaire (BAFT; Ruíz et al., 2014).The assessed construct refers to the degree to which individuals become entangled with anxiety-related thoughts, treating them as literal truths. The BAFT has 16 items and presents a multidimensional structure (i.e., emotion regulation, negative assessment and a general factor). Range: 16-112. Higher scores reflect greater cognitive fusion (worse outcome)

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

Secondary Outcomes (1)

• Substance use abstinence

  baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention

Study Arms (2)

Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors

EXPERIMENTAL

The intervention consists of 12 sessions that include 28 exercises. The treatment is structured into seven modules: cultivating motivation and defining intervention goals; emotions and their function; emotional awareness: mindfulness; cognitive flexibility; coping with emotion-driven behaviors; exposure to physical sensations and emotions; and relapse prevention.

Behavioral: Transdiagnostic cognitive-behavioral therapy

Treatment as Usual (TAU) for addictive behaviors

ACTIVE COMPARATOR

This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.

Behavioral: Treatment as usual

Interventions

Transdiagnostic cognitive-behavioral therapy BEHAVIORAL

This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)

Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors

Treatment as usual BEHAVIORAL

This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.

Treatment as Usual (TAU) for addictive behaviors

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oviedo: lead
• Asociación Proyecto Hombre: collaborator

Study Sites (1)

University of Oviedo

Oviedo, Spain

Location

Related Publications (3)

• 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 BACKGROUND

• 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.2025.1452976. eCollection 2025.

  PMID: 40589783 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Behavior, Addictive; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 30, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)