Addictive Behaviors, Emotion Regulation
Conditions
Keywords
Transdiagnostic, Psychological treatment, Unified Protocol, Addictive Behaviors, Pilot Study
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.
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
This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)
BEHAVIORALTreatment as usual
This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.
Sponsors
University of Oviedo
Asociación Proyecto Hombre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Currently receiving treatment for substance use in either an inpatient or outpatient setting. 2. Meet DSM-5 criteria for Major Depressive Disorder or Anxiety Disorder (i.e., Panic Disorder, Generalized Anxiety Disorder, Agoraphobia, Social Anxiety Disorder).
Exclusion criteria
1. Not currently engaged in inpatient or outpatient substance use treatment. 2. Failure to meet diagnostic criteria for depression or any of the specified anxiety disorders within the past 12 months. 3. Severe cognitive impairment or acute psychiatric mental health disorders (i.e., psychosis, bipolar disorder) that would preclude participation in the assessment and treatment. 4. Active suicidal behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance use abstinence | baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention | 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. |
Countries
Spain
Outcome results
None listed