Addictive BehaviorsUP-TIED-ABNCT07738081
A Novel Adaptation of the Unified Protocol (UP) as a Transdiagnostic Intervention for Emotional Disorders in Addictive Behaviors
A study testing Transdiagnostic cognitive-behavioral therapy and Treatment as usual in people with Addictive Behaviors and Emotion Regulation, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addictive Behaviors, Emotion Regulation
- What is being tested?
- Transdiagnostic cognitive-behavioral therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors
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.
Read the 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:
- Better understand their emotions
- Develop healthier emotion regulation strategies
- Reduce emotional distress
- Decrease addictive behaviors
The protocol is based on:
- The contextual model, which understands emotional problems within each person's life context.
- Transdiagnostic approaches, which target psychological processes that are common across different mental health disorders.
- An adaptation of the Unified Protocol (UP) developed by Dr. David Barlow, an evidence-based treatment for emotional disorders.
- Additional third wave psychological treatment procedures that have demonstrated effectiveness in improving emotion regulation.
- Conditions
- Addictive Behaviors, Emotion Regulation
- Being tested
- Transdiagnostic cognitive-behavioral therapy, Treatment as usual
- Keywords
- Transdiagnostic, Psychological treatment, Unified Protocol, Addictive Behaviors, Pilot Study
- Medical subject headings
- Behavior, Addictive, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic cognitive-behavioral therapyBehavioural
This intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow)
Treatment as usualBehavioural
This intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention
Secondary outcomes (1)
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.
Measured: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start5 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Addictive BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Proyecto Hombre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738081
- Sponsor's protocol ID
- ceimpa. 2026.126
- Other IDs
- D
- Acronym
- UP-TIED-AB
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42067774Meyer 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.
PubMed 40589783Carlucci 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.
PubMed 34098412
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors
- ClinicalTrials.gov ID
- NCT07738081
- Acronym / sponsor ID
- UP-TIED-AB / ceimpa. 2026.126
- Conditions
- Addictive Behaviors, Emotion Regulation
- Keywords
- Transdiagnostic, Psychological treatment, Unified Protocol, Addictive Behaviors, Pilot Study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Collaborators
- Asociación Proyecto Hombre
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Better understand their emotions
- Develop healthier emotion regulation strategies
- Reduce emotional distress
- Decrease addictive behaviors
The protocol is based on:
- The contextual model, which understands emotional problems within each person's life context.
- Transdiagnostic approaches, which target psychological processes that are common across different mental health disorders.
- An adaptation of the Unified Protocol (UP) developed by Dr. David Barlow, an evidence-based treatment for emotional disorders.
- Additional third wave psychological treatment procedures that have demonstrated effectiveness in improving emotion regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors | Experimental | Behavioral: Transdiagnostic cognitive-behavioral therapyThe 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. |
| Treatment as Usual (TAU) for addictive behaviors | Active comparator | Behavioral: Treatment as usualThis intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic cognitive-behavioral therapyThis intervention consists of 12 sessions adapted from the Unified Protocol (David Barlow) | Behavioural | Transdiagnostic Intervention Protocol for Emotional Problems in Addictive Behaviors |
| Treatment as usualThis intervention is framed under the cognitive-behavioral therapy. It is delivered in 12 treatment sessions. | Behavioural | Treatment as Usual (TAU) for addictive behaviors |
Primary outcome
Anxiety severity and related functional impairment measured using the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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 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
Time frame: 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
Time frame: 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)
1 secondary outcome
Substance use abstinence
Time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 42067774Osma 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.
- Background: PubMed 40589783Meyer 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.
- Background: PubMed 34098412Carlucci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic cognitive-behavioral therapy and Treatment as usual in people with Addictive Behaviors and Emotion Regulation, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety severity and related functional impairment measured using the Overall Anxiety Severity and Impairment Scale (OASIS) (time frame: baseline/immediately after the intervention at 12 weeks/at 1-month post-intervention and 3 months post-intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.