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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transdiagnostic cognitive-behavioral therapy: This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)

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

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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