Anxiety, Depression, Emotional Disorder
Conditions
Keywords
Emotional disorders, Unified Protocol, Transdiagnostic intervention, Transdiagnostic mechanisms, Online and in-person formats
Brief summary
The Unified Protocol (UP) is a transdiagnostic, emotion-focused, cognitive-behavioral intervention developed to treat emotional disorders. The UP intervenes in the transdiagnostic mechanisms linked to the etiology and maintenance of emotional disorders, promoting adaptive emotional regulation strategies (e.g. conscious awareness of emotions; cognitive flexibility). Originally developed for the in-person and individual format, the UP can be adapted and implemented in the online group format. It offers other advantages, namely reduced waiting lists and treatment costs, an easier implementation and increased access to psychological treatment for the most isolated populations. This clinical trial aims to implement and evaluate the acceptability, feasibility and effectiveness of UP in an online group format in a clinical population with a primary diagnosis of anxiety disorder and/or mood disorder, compared with UP in an in-person group format. It also aims to explore the psychological processes of therapeutic change (e.g., cognitive flexibility) and their potential mediating role in the response to treatment. Additionally, the study seeks to examine group relationship processes (e.g., group cohesion and therapeutic alliance) and participants' attitudes toward different therapy delivery modalities (online versus in-person), as potential factors influencing treatment engagement and outcomes. Participants will be recruited through online advertisements, including social media platforms (e.g., Facebook and Instagram), the UpC3 website (https://upc3.pt), referrals from other mental health services, and flyers and posters displayed at the University of Coimbra. A total of 54 participants with a primary diagnosis of an anxiety disorder and/or mood disorder were randomized (1:1 allocation ratio) to one of two conditions: (1) UP delivered in an online synchronous group format (n = 28) or (2) UP delivered in an in-person group format (n = 26). In both conditions, participants received 12 weekly 2-hour sessions of the UP in group. Outcomes were assessed at baseline (T0), mid-treatment (T1), post-treatment (T2), and at 3-month (T3) and 6-month (T4) follow-up assessments.
Interventions
BEHAVIORALUnified Protocol
The Unified Protocol (UP) is a transdiagnostic cognitive-behavioral intervention developed to target the core mechanisms underlying emotional disorders. The intervention consists of eight treatment modules focused on enhancing emotional awareness, cognitive flexibility, reducing emotional avoidance and maladaptive emotion-driven behaviors, increasing tolerance of physical sensations, and promoting emotion-focused exposure.
Sponsors
University of Coimbra
Fundação para a Ciência e a Tecnologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Once participants meet the inclusion criteria, they will be randomly assigned in a 1:1 ratio to one of two conditions: (1) an experimental group receiving the UP in a group format via videoconference, or (2) a control group receiving the UP in a group format delivered in person. Both conditions will follow the same treatment manual, session structure, duration, and therapist training, differing only in the mode of delivery. Outcomes will be assessed at baseline, mid-treatment, post-treatment, and 3 and 6 months follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18; * be Fluent in Portuguese; * a score greater than 9 on the Patient Health Questionnaire-9 (PHQ-9; Ferreira et al., 2019) and/or a score of 8 or higher on the Generalized Anxiety Disorder-7 (GAD-7; Sousa et al., 2015); * principal diagnosis (most interfering and severe) of an emotional disorder (i.e. anxiety, depression and other related disorder) according to DSM-5 criteria * be able to attend treatment sessions and assessments, regardless of the therapeutic format (online and in-person); * participants taking pharmacological treatment will be asked to maintain the same dosages and medications for at least 1 month prior to the start of treatment and during treatment; * to have access to a computer or mobile phone with Internet and Webcam;
Exclusion criteria
* current diagnosis of severe mental disorder (e.g., bipolar disorder, schizophrenia, eating disorders), moderate to severe substance use disorder or there is suicide risk at the time of assessment * not being able to participate in more than half of the intervention program sessions * to have previously received at least 8 sessions of psychological treatment consisting of cognitive-behavioral principles * currently receiving other psychological treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in depressive symptoms | Baseline, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale used to measure the severity of depressive symptoms, answered on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Almost every day). Total scores range from 0 to 27, with higher scores indicating greater depressive severity, and scores above 9 suggest clinically significant depressive symptoms. |
| Changes from baseline in anxiety symptoms | Baseline, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 (Sousa et al., 2015) is a 7-item self-report scale used to measure the severity of anxiety symptoms, answered on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Almost every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity, and scores equal to or greater than 8 suggesting clinically significant anxiety symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in severity and degree of impairment of depressive symptoms | Baseline, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Overall Depression Severity and Impairment Scale (ODSIS). It comprises five items answered on a 5-Likert scale ranging from 0 (e.g., I didn't feel depressed) to 4 (e.g., Constant depression). The total score is the sum of all the items and ranges from 0 to 20. |
| Changes from baseline in severity and degree of impairment of anxiety symptoms | Baseline, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Overall Anxiety Severity and Impairment Scale. The five items are rated on a 5-Likert scale ranging from 0 (e.g., I didn't feel anxious) to 4 (e.g., Constant anxiety). The total score ranges from 0 to 20. |
| Changes from baseline in transdiagnostic mechanisms | Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the The Multidimensional Emotional Disorder Inventory (MEDI). MEDI is a 49-item self-reported questionnaire used to assess nine transdiagnostic dimensions: Neurotic temperament, Positive temperament, Depressed mood, Autonomic arousal, Somatic anxiety, Social concerns, Intrusive cognitions, Traumatic reexperiencing, and Avoidance. All items are rated on a 9-point Likert scale ranging from 0 (not characteristic of me) to 8 (extremely characteristic of me). |
| Changes from baseline in emotional regulation | Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). It comprises 18 items, rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The total score was calculated as the mean of all items excluding the Awareness items, with higher scores indicating a greater level of emotional dysregulation. |
| Changes from baseline in mindfulness | Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the Mindful Attention Awareness Scale (MAAS). MAAS is a 15-item self-report questionnaire. Items are rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never). Total scores range from 15 to 90, with higher scores indicating greater mindfulness. |
| Changes from baseline in behavioral ativation | Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with The Behavioral Activation for Depression Scale-Short Form (BADS-SF). It comprises 9 items, rated on a 7-point scale ranging from 0 to 6, with higher total scores indicating greater levels of activation. |
| Changes from baseline in quality of life | Baseline, week 12 (end of treatment), and 3- and 6-month follow-up | Measured with the EUROHIS-QOL-8. This self-report scale comprises 8 items, answered on a 5-point Likert scale (from 1- not at all/very dissatisfied to 5 - completely/very satisfied). Higher values represent better-perceived quality of life. |
Countries
Portugal
Outcome results
None listed