An interventional study of UKADO Content - problem-focused and UKADO Content - resource-focused in Depressive Disorders and Anxiety Disorders, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
The OPTIBRIEF study investigates different versions of a digital ultra-brief intervention (UKADO - a German acronym for ultra-brief intervention against anxiety and depression online) during the waiting period for psychotherapy. Using a factorial trial design, the components 1) intervention content, 2) human support, and 3) expectation-fostering elements will be examined.
After completing initial questionnaires and participating in a diagnostic interview, participants are randomly assigned to one of eight groups and work through a specific version of UKADO. The program can be completed in a session of approximately 60 minutes, after which the exercises should continue to be used. Participants then complete another set of questionnaires at specific time points (after 2 weeks, 5 weeks, 9 weeks, and 24 weeks). A selection of participants also takes part in another telephone appointment to assess experiences with UKADO.
With the OPTIBRIEF study, the investigators aim to determine which version of the program is most suitable for individuals waiting for a psychotherapy slot. To this end, the investigators examine the effects on anxiety and depression symptom severity, as well as aspects such as participants' experiences with the program.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 312 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Problem-focused condition of UKADO without human support or expectation fostering elements
Behavioral: UKADO Content - problem-focused
Problem-focused condition of UKADO without human support but with expectation fostering elements
Behavioral: UKADO Content - problem-focused · Behavioral: Expectation fostering elements
Problem-focused condition of UKADO with human support but no expectation fostering elements
Behavioral: UKADO Content - problem-focused · Behavioral: Human support
Problem-focused condition of UKADO with human support and expectation fostering elements
Behavioral: UKADO Content - problem-focused · Behavioral: Human support · Behavioral: Expectation fostering elements
Resource-focused condition of UKADO without human support and without expectation fostering elements
Behavioral: UKADO Content - resource-focused
Resource-focused condition of UKADO without human support but with expectation fostering elements
Behavioral: UKADO Content - resource-focused · Behavioral: Expectation fostering elements
Resource-focused condition of UKADO with human support but without expectation fostering elements
Behavioral: UKADO Content - resource-focused · Behavioral: Human support
Resource-focused condition of UKADO with human support and with expectation fostering elements
Behavioral: UKADO Content - resource-focused · Behavioral: Human support · Behavioral: Expectation fostering elements
UKADO is a digital ultra-brief intervention intended to reduce symptoms of depressive disorders and anxiety disorders. Content is either problem-focused or resource-focused. This version is problem-focused
UKADO is a digital ultra-brief intervention intended to reduce symptoms of depressive disorders and anxiety disorders. Content is either problem-focused or resource-focused. This version is resource-focused.
Human support is provided as two weeks of guidance for study participants
Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.
Depression and anxiety symptom severity assessed by the PHQ-ADS
Self-reported depression and anxiety symptom severity will be measured using the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS; Kroenke et al., 2016; 2019). The PHQ-ADS combines the Patient Health Questionnaire 9-item depression scale (PHQ-9) and 7-item Generalized Anxiety Disorder scale (GAD-7). Scores range from 0 to 48, with higher scores indicating greater symptom severity. The primary endpoint is at 2 weeks. Assessments will also be conducted at baseline, 5 weeks, 9 weeks, and 24 weeks.
Time frame: At two weeks
Depression and anxiety symptom severity assessed by the PHQ-ADS
Self-reported depression and anxiety symptom severity will be measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS; Kroenke et al., 2016; 2019). Scores range from 0 to 48, with higher scores indicating greater symptom severity. Assessments are conducted at baseline, 2 weeks, 5 weeks, 9 weeks, and 24 weeks.
Time frame: 5 weeks, 9 weeks
Depression and anxiety symptom severity assessed by the PHQ-ADS
Self-reported depression and anxiety symptom severity will be measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS; Kroenke et al., 2016; 2019). Scores range from 0 to 48, with higher scores indicating greater symptom severity. Assessments are conducted at baseline, 2 weeks, 5 weeks, 9 weeks, and 24 weeks.
Time frame: 24 weeks
Depression symptom severity
Depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) scale that is a part of the PHQ-ADS (Kroenke et al., 2016). The PHQ-9 measures the severity of depressive symptoms and has demonstrated high validity and reliability. Scores range from 0 (no depressive symptoms) to 27 (severe depressive symptoms).
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.
Anxiety symptom severity
Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 scale (GAD-7) that is a part of the PHQ-ADS (Kroenke et al., 2016). The GAD-7 measures the severity of generalized anxiety symptoms and has demonstrated strong validity and reliability. Scores range from 0 (no general anxiety symptoms) to 21 (severe general anxiety symptoms)
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
Quality of life (EQ-5D-5L)
Quality of life assessed with the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L; Herdman et al., 2001). This measure includes five dimensions-Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression-each rated on a 5-point scale from 1 (no problems) to 5 (extreme problems).
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
Satisfaction with treatment
Satisfaction assessed with the Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson \& Zwick, 1982), adapted for internet interventions. The CSQ-8 consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater satisfaction. The German version has demonstrated high reliability and validity (Kriz et al., 2008).
Time frame: two weeks
Negative effects
Negative treatment effects of UKADO assessed with the Negative Effects Questionnaire (NEQ; Rozental et al., 2019). This 20-item measure evaluates adverse effects during psychological treatments, including symptoms, therapy quality, dependency, stigma, and hopelessness.
Time frame: 2 weeks, 5 weeks, 9 weeks, 24 weeks
Resource activation and problem mastery
Resource activation and problem mastery assessed with selected items from the Bern Post Session Report 2000, Patient and Therapist Versions (Flückiger et al., 2010), adapted for the digital intervention.
Time frame: 2 weeks, 5 weeks, 9 weeks
Therapeutic alliance
Therapeutic alliance measured with the Working Alliance Inventory for Guided Internet Interventions (WAI-I; Gomez Penedo et al., 2020), adapted to assess alliance with the study team. The 12 items assess agreement on therapeutic tasks, agreement on therapeutic goals, and emotional bond, rated on a 5-point Likert scale. Scores can range from 12 to 60, a higher score means a higher working alliance.
Time frame: 2 weeks, 5 weeks, 9 weeks
Treatment expectations
Treatment expectations assessed with the Treatment Expectancy Questionnaire (TEX-Q; Alberts et al., 2020; Shedden-Mora et al., 2023), covering six subscales: Treatment benefit, Positive impact, Adverse events, Negative impact, Process, and Behavioral control. Scores range from 0 to 10, with higher scores indicating greater expectations.
Time frame: Baseline, two weeks, 5 weeks, 9 weeks
Patient experience interviews
Qualitative interviews conducted with a subset of participants using a study-specific guide developed to explore participants' experiences with the intervention.
Time frame: 9 weeks
Patient experience with UBT and its effect on f2f therapy experience at follow-up
Impact of UBT on f2f therapy experience (assessed with study-specific questions)
Time frame: 24 weeks
UBT uptake
Uptake of the UBT will be assessed at 2 weeks by reporting the number of patients who used the UBT (logged in).
Time frame: 2 weeks
UBT adherence
Usage of (adherence to) the UBT will be assessed at 2 weeks with a composite adherence score based on pages visited, time spent, and user input.
Time frame: 2 weeks
Psychotherapy uptake
Self-reported psychotherapy uptake will be assessed via online questionnaires by recording the number of patients opting out of face-to-face (f2f) therapy after UBT and the number of patients who started f2f psychotherapy at each timepoint.
Time frame: 2 weeks, 5 weeks, 9 weeks, 24 weeks
Psychotherapy use
Self-reported psychotherapy use will be assessed via online questionnaire to record the number of sessions attended at each timepoint.
Time frame: 2 weeks, 5 weeks, 9 weeks, 24 weeks
Adverse Events
The number and type of adverse events occurring during the study will be reported for the entire sample.
Time frame: Up to 24 weeks.
Plan to share: Yes
Supporting information: Study protocol
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