Unified Protocol Group Treatment in a University Outpatient Clinic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Bergen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-40
Fulfilling diagnostic criteria for an anxiety disorder and/or unipolar depression (ICD F.3x - 4x)
Motivated for short-term treatment in group format
Disqualifiers
Suicidality
Self-harm
Severe psychiatric disorder (bipolar disorder, psychosis)
Substance use disorders
Trial design
Design model
Single group
Treatments tested in this trial
Unified Protocol
BehavioralThe Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Unified Protocol group treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to follow-up at 6 monthsSecondary outcomes
1
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).
Time frame
From enrollment to follow-up at 6 months2
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).
Time frame
From enrollment to follow-up at 6 months3
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).
Time frame
From enrollment to follow-up at 6 months4
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.
Time frame
From enrollment to follow-up at 6 monthsOther outcomes
1
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.
Time frame
This scale will be administered only at pre-treatment as a possible predictor of change.2
Group Session Rating Scale (GSRS)
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.
Time frame
At each treatment session through the 12 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov