Study on a Digital Ultra-Brief Intervention During Wait Times for Psychotherapy (OPTIBRIEF)

Optimizing a Digital Ultra-brief Treatment for Patients Waiting for Face-to-face Psychotherapy: An Investigation of Treatment Content, Human Support, and Patient Expectations (OPTIBRIEF)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders; Depressive Disorders
• Intervention / Treatment: Behavioral: UKADO Content - problem-focused; Behavioral: Expectation fostering elements; Behavioral: Human support; Behavioral: UKADO Content - resource-focused

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Luisa Bielinski, PhD; Phone Number: +41 31 684 39 37; Email: laura.bielinski@unibe.ch
• Study Contact Backup: Name: Thomas Berger, PhD; Email: thomas.berger@unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Department of Clinical Psychology and Psychotherapy, University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Read the patient information and return signed written informed consent sheet
• Currently waiting for outpatient psychotherapy (self-report at baseline and assessed per telephone)
• Age ≥ 18 (self-report at baseline and assessed per telephone)
• Scoring equal to or above 10 on the PHQ-ADS (self-report at baseline)
• Fulfilling diagnostic criteria of one or more of the following disorders assessed with the Diagnostic Short-Interview for Mental Disorders (Mini-DIPS, DSM-5 version; Margraf et al., 2017): Major Depressive Disorder, Persistent Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder
• Sufficient German skills (self-report at baseline)
• Access to the internet (self-report at baseline)

Exclusion Criteria:

• Acute suicidality assessed during the telephone interview (Mini-DIPS)
• Currently taking part in psychotherapy or a scheduled start of psychotherapy prior to the assessment 14 days post-randomization (assessed via self-report and during the DIPS telephone interview)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Problem-focused content; Problem-focused condition of UKADO without human support or expectation fostering elements	Behavioral: UKADO Content - 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 problem-focused
Experimental: Problem-focused content and expectation fostering elements; Problem-focused condition of UKADO without human support but with expectation fostering elements	Behavioral: UKADO Content - 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 problem-focused; Behavioral: Expectation fostering elements; Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.
Experimental: Problem-focused content and human support; Problem-focused condition of UKADO with human support but no expectation fostering elements	Behavioral: UKADO Content - 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 problem-focused; Behavioral: Human support; Human support is provided as two weeks of guidance for study participants
Experimental: Problem-focused content + human support + expectation fostering elements; Problem-focused condition of UKADO with human support and expectation fostering elements	Behavioral: UKADO Content - 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 problem-focused; Behavioral: Expectation fostering elements; Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.; Behavioral: Human support; Human support is provided as two weeks of guidance for study participants
Experimental: Resource-focused content; Resource-focused condition of UKADO without human support and without expectation fostering elements	Behavioral: UKADO Content - resource-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.
Experimental: Resource-focused content and expectation fostering elements; Resource-focused condition of UKADO without human support but with expectation fostering elements	Behavioral: Expectation fostering elements; Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.; Behavioral: UKADO Content - resource-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.
Experimental: Resource-focused content and human support; Resource-focused condition of UKADO with human support but without expectation fostering elements	Behavioral: Human support; Human support is provided as two weeks of guidance for study participants; Behavioral: UKADO Content - resource-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.
Experimental: Resource-focused content + human support + expectation fostering elements; Resource-focused condition of UKADO with human support and with expectation fostering elements	Behavioral: Expectation fostering elements; Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.; Behavioral: Human support; Human support is provided as two weeks of guidance for study participants; Behavioral: UKADO Content - resource-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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)	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).	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).	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.	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.	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.	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.	Baseline, two weeks, 5 weeks, 9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience interviews	Qualitative interviews conducted with a subset of participants using a study-specific guide developed to explore participants' experiences with the intervention.	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)	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).	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.	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.	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.	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.	Up to 24 weeks.

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Macquarie University, Australia
• Investigators: Principal Investigator: Laura Luisa Bielinski, PhD, Department of Clinical Psychology and Psychotherpay, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 25, 2025
• First Submitted That Met QC Criteria: September 3, 2025
• First Posted (Estimated): September 11, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Psychotherapy; Factorial trial; OPTIBRIEF; Ultra-brief treatment; Wait time
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Behavior; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2025-00844; HumRes67051 (Registry Identifier: HumRes); BASEC2025-00844 (Registry Identifier: BASEC); SNCTP000006475 (Registry Identifier: SNCTP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No