By InvitationNot Applicable

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

Spain60 participantsStarted 2026-01-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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).

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

Positive Emotion Dysregulation

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

Negative emotion dysregulation

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

Experiential avoidance

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

Present-Moment Awareness

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

Trial details

NCT IDNCT07738081

SponsorUniversity of Oviedo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More Addictive Behaviors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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).

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

Positive Emotion Dysregulation

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

Negative emotion dysregulation

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

Experiential avoidance

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

Present-Moment Awareness

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