An interventional study of Transdiagnostic cognitive-behavioral therapy and Treatment as usual in Addictive Behaviors and Emotion Regulation, sponsored by University of Oviedo. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Oviedo · Not applicable, Interventional, and Treatment
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.
The goal is to implement and evaluate a structured intervention program that helps people undergoing inpatient or outpatient treatment for substance use disorders to:
The protocol is based on:
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →University of Oviedo is the lead sponsor of 47 studies on the registry; 10 are open to participants now.
Compared within Emotional Regulation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Behavior, Addictive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.
Behavioral: Treatment as usual
This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)
This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.
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)
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).
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
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
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)
Time frame: 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)
Time frame: 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)
Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention
Substance use abstinence
Abstinence will be evaluated using 7-day and 1-month point prevalence measures, defined as self-reported absence of substance use during the specified time frames prior to assessment.
Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 9 months is below that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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