Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.
Background Anxiety and depression are the most common mental disorders, incurring vast personal and societal costs. While effective evidence-based treatments exist, healthcare systems struggle to meet the growing demand for services. A key challenge in delivering care is that most treatments are diagnosis specific. This complicates training and implementation due to clinicians having to learn multiple treatment manuals. In addition, these single-disorder treatments may also often have poor applicability to the complex symptoms and patterns of comorbidity typically seen in real-world clinical settings. As a response to these challenges, several transdiagnostic treatment protocols have been developed to target psychological processes underlying different diagnoses. One such model is the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) developed by David Barlow and colleagues. UP addresses the functional processes that maintain emotional disorders, such as negative reactions to emotions and avoidance behaviors.
The Unified Protocol (UP) has shown non-inferiority to diagnosis-specific CBT and superiority to treatment as usual in both individual and group formats. Meta-analyses confirm its effectiveness for comorbid emotional disorders and suggest potential for cost-effective, scalable implementation.
Knowledge gaps
Study objectives This study aims to explore outcomes, processes of change, and user experiences of UP group treatment for patients with emotional disorders in a naturalistic clinical sample in a Norwegian setting. Additionally, it will compare the clinical sample to a healthy control group to better understand how transdiagnostic characteristics serve as vulnerability or resilience factors in the development of emotional disorders. Lastly, the study examines whether novice therapists can be trained to deliver the treatment with high levels of fidelity based on ratings of adherence and competence.
Main aims and research questions i. Assessing treatment effectiveness: To determine whether UP group treatment leads to improvements in key clinical outcomes, identify factors that influence these outcomes, and assess any negative treatment effects.
Research questions:
ii. Examining processes of change: To investigate the role of emotion regulation, interoception, and UP skill use as predictors and mediators of treatment outcomes, using both self-report and objective measures.
Research questions:
iii. Understanding patients' experience of UP: To explore patients' experience of UP treatment through in-depth qualitative interviews.
Research questions:
iv.) Understanding transdiagnostic factors in emotional vulnerability and resilience: To explore whether individuals with emotional disorders differ cross-sectionally from healthy controls.
Research question:
- Do patients with emotional disorders differ significantly from healthy controls on measures of emotion regulation, acceptance, cognitive flexibility, and psychophysiological markers (interoception, heart rate variability)?
v.) Examining UP group therapy delivered by novices: To assess whether novice therapists can be trained to deliver UP with high fidelity.
Research question:
- Can novice therapists (i.e., graduate students in clinical psychology under supervision) be trained to high levels of fidelity in delivering the UP group treatment?
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unified Protocol group treatment | Experimental | The Unified Protocol (UP) is a time-limited modular treatment addressing core emotion regulation difficulties in patients with emotional disorders. There will be 8-10 patients and two or three therapists in the group. Treatment consists of one individual session of diagnostic assessment, and one or two individual preparation sessions (case formulation and goal setting), and 12 weekly 2 ½ hour group treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Protocol | Behavioral | The Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format |
|
| Measure | Description | Time Frame |
|---|---|---|
| WHO-5: Wellbeing index | The WHO-5 is a self-report measure of positive mental health. It consists of five items that are rated on a 6-point scale from 'All of the time' to 'At no time'. High scores indicate a more positive rating of wellbeing | From enrollment to follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Work and Social Adjustment Scale | The WSAS is a five-item scale that addresses impairments in work/study, home, social life, private leisure activities, and interpersonal relations. Each item is self-rated on a nine-point Likert scale that ranges from "Not at all" (0) to "Severely impaired" (8). | From enrollment to follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility Rating Scale | The version of the Credibility Rating Scale used in this study is a 5-item adapted version of the original Credibility Rating Scale developed by Devilly & Borkovec. | This scale will be administered only at pre-treatment as a possible predictor of change. |
| Group Session Rating Scale (GSRS) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon Vøllestad, Ph.D. | Contact | 0047 95 21 32 86 | jon.vollestad@uib.no | |
| Elisabeth Schanche, Ph.D. | Contact | 0047 97 77 42 17 | elisabeth.schanche@uib.no |
| Name | Affiliation | Role |
|---|---|---|
| Jon Vøllestad, Ph.D. | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Psychology | Recruiting | Bergen | Vestland | 5009 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
This is a single-arm uncontrolled naturalistic trial. All eligible patients will receive the Unified Protocol (UP) intervention, but will be randomly assigned to receive treatment from either experienced psychologists or psychology students.
Not provided
Not provided
Not provided
Not provided
| Patient Health Questionnaire (PHQ-9) |
The PHQ-9 is a nine-item scale measuring depression severity. Each item is self-rated on a four-point Likert scale that ranges from "Not at all" (0) to "Nearly every day" (3). |
| From enrollment to follow-up at 6 months |
| Generalized Anxiety Disorder Scale (GAD-7) | The GAD-7 is a seven-item scale measuring anxiety severity. Each items is self-rated on a four point Likert scale that ranges from "Not at all" (0) to "Nearly every day" (3). | From enrollment to follow-up at 6 months |
| Multidimensional Emotional Disorders Inventory (MEDI) | The MEDI is a 49-item scale measuring nine transdiagnostic factors involved in emotional disorders. Each item is self-rated on a nine point Likert scale that ranges from 0 (Not at all characteristic of me) to 8 (Totally characteristic of me). The dimensions measured are Neurotic temperament, positive temperament, depressive mood, autonomic arousal, somatic anxiety, intrusive thoughts, traumatic re-experiencing and avoidance. | From enrollment to follow-up at 6 months |
| Level of Personality Functioning Scale Brief Form (LPFS-BF) | The LPFS-BF is a 12-item scale measuring the level of personality functioning based on the Criterion "A" of the alternative model for personality disorders in the DSM-5; Identity, self-direction, empathy and intimacy. Each item is self-rated on a 4-point Likert scale that ranges from 0 (Little or no impairment) to 3 (Severe impairment). | From enrollment to follow-up at 6 months |
| Difficulty in Emotion Regulation Scale (DERS-16) | The DERS is a 16-item scale measuring individuals' typical levels of difficulties in emotion regulation. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Almost never) to 5 (Almost always). | From enrollment to follow-up at 6 months |
| Acceptance and Action Questionnaire- version 2 (AAQ-II) | The AAQ-II is a 7-item scale measuring experiential avoidance and psychological inflexibility. Each item is self-rated on a 7-point Likert scale that ranges from 1 (Never right) to 5 (Always right). The total score ranges between 0-49. Higher scores indicate less psychological flexibility and more experiential avoidance. | From enrollment to follow-up at 6 months |
| Five Facet Mindfulness Questionnaire (FFMQ) | The FFMQ is a 15-item scale measuring mindfulness with regard to thoughts, experiences, and actions in daily life. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Never or rarely true) to 5 (Very often or always true). | From enrollment to follow-up at 6 months |
| Unified Protocol Cognitive Skills Questionnaire (UP-CSQ) | The UP-CSQ is a 7-item scale measuring the cognitive skills taught in the UP. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Never) to 5 (Always or when needed) | From enrollment to follow-up at 6 months |
| Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) | The MAIA is a 37-item scale measuring interoceptive awareness. Each item is self-rated on a 6-point Likert scale that ranges from 0 (Never) to 5 (Always). | From enrollment to follow-up at 6 months |
| Overall Anxiety Severity and Impairment Scale (OASIS) | The OASIS is a 5-item scale measuring the frequency and severity of anxiety, avoidance, work/school/home interference, and social interference due to anxiety. Each item is self-rated on a 5-point Likert scale that ranges from 0 (None, never) to 4 (Extreme, constant). The OASIS is used as an in-session UP measures to examine processes of change | At each treatment session through the 12 weeks of treatment |
| Overall Depression Severity and Impairment Scale (ODSIS) | The ODSIS is a 5-item scale measuring the frequency and severity of depression symptoms, avoidance, work/school/home interference, and social interference due to depression. Each item is self-rated on a 5-point Likert scale that ranges from 0 (None/never) to 4 (Extreme/constant). The ODSIS is used as an in-session UP measures to examine processes of change | At each treatment session through the 12 weeks of treatment |
| Unified Protocol Skill Use Scale (UPSUS) | The UPSUS is a 7-item scale measuring the frequency with which individuals use UP-skills in distressing situations. Each item is self-rated on a 6-point Likert scale that ranges from 0 (Not at all) to 5 (Nearly all the time). Each item was written to describe core skills taught in each of the five core UP-modules. The UPSUS is used as an in-session UP measure to examine processes of change | At each treatment session through the 12 weeks of treatment |
| Dimension of Skillfulness and Use Scale (DSUS) | The DSUS is a 4-item scale measuring the understanding of UP skills learned in the prior session, frequency of skill use, quality of skill use, and effectiveness and skill use. Each item is self-rated on a 5-point Likert scale that ranges from 0 (Not at all) to 4 (Extremely well/every day). The DSUS is used as an in-session UP measures to examine processes of change | At each treatment session through the 12 weeks of treatment |
| Client Satisfaction Questionnaire (CSQ-8) | The CSQ-8 is an 8-item scale measuring clients' satisfaction with treatment. Each item is scored on a 4-point Likert scale that ranges from 0 to 3. | At final treatment session (week 12) |
| The Negative Effects Questionnaire (NEQ) | The NEQ is a 32-item scale measuring adverse or unwanted events during treatment. Each item is designed to assess adverse effects related to psychological treatments. Items are scored on a five-point Likert scale (0-4) and differentiates between treatment-related negative effects and those from external factors. | At final treatment session (week 12) |
| The Heartbeat Counting Task (HBC) | The HBC task evaluates three dimensions of interoception: 1) Interoceptive accuracy in the form of ratio of detected to actual heartbeats, 2) Interoceptive sensibility in the form of self-reported interoception through interviews and questionnaires, and 3) Interoceptive awareness in the form of metacognitive awareness of accuracy, measured by the correlation between confidence and actual performance using receiver operating characteristics (ROC) curve analysis. | From enrollment to follow-up at 6 months |
| Heart Rate Variability (HRV) via a 24-hour ECG Monitoring. | 24-hour ECG data will be collected using BioPoint sensors from SiFi Labs, which are wearable, small and designed for continuous monitoring. The sensor is placed below the sternum. The data are not intended for clinical evaluation of heart function but suitable for investigating potential changes in HRV before and after psychotherapy in addition to possible differences in HRV in groups of patients with emotional disorders compared to healthy controls. | From enrollment to follow-up at 6 months |
The GSRS is a 4-item scale measuring each participant's experience of alliance in the UP group therapy. Each item is scored on a visual analog scale, covering the patient's experience of the quality of the relations to both the therapist and the other patients in the group, the personal relevance of the goals and themes of the group session, the fit of the approach utilized in the treatment, and the general experience of being part of the group. |
| At each treatment session through the 12 weeks of treatment |