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)
4 other identifiers
interventional
312
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedStudy Start
First participant enrolled
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
November 18, 2025
November 1, 2025
2.2 years
August 25, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Depression and anxiety symptom severity assessed by the PHQ-ADS
5 weeks, 9 weeks
Depression and anxiety symptom severity assessed by the PHQ-ADS
24 weeks
Depression symptom severity
Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.
Anxiety symptom severity
Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
Quality of life (EQ-5D-5L)
Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
- +5 more secondary outcomes
Other Outcomes (7)
Patient experience interviews
9 weeks
Patient experience with UBT and its effect on f2f therapy experience at follow-up
24 weeks
UBT uptake
2 weeks
- +4 more other outcomes
Study Arms (8)
Problem-focused content
EXPERIMENTALProblem-focused condition of UKADO without human support or expectation fostering elements
Problem-focused content and expectation fostering elements
EXPERIMENTALProblem-focused condition of UKADO without human support but with expectation fostering elements
Problem-focused content and human support
EXPERIMENTALProblem-focused condition of UKADO with human support but no expectation fostering elements
Problem-focused content + human support + expectation fostering elements
EXPERIMENTALProblem-focused condition of UKADO with human support and expectation fostering elements
Resource-focused content
EXPERIMENTALResource-focused condition of UKADO without human support and without expectation fostering elements
Resource-focused content and expectation fostering elements
EXPERIMENTALResource-focused condition of UKADO without human support but with expectation fostering elements
Resource-focused content and human support
EXPERIMENTALResource-focused condition of UKADO with human support but without expectation fostering elements
Resource-focused content + human support + expectation fostering elements
EXPERIMENTALResource-focused condition of UKADO with human support and with expectation fostering elements
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- Macquarie University, Australiacollaborator
Study Sites (1)
Department of Clinical Psychology and Psychotherapy, University of Bern
Bern, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Luisa Bielinski, PhD
Department of Clinical Psychology and Psychotherpay, University of Bern
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants are assigned to 8 conditions. Due one factor being human support (on vs. off), that can reasonably be guessed, this is not considered full participant masking.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 11, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL