Depressive DisordersOPTIBRIEFNCT07167849
Study on a Digital Ultra-Brief Intervention During Wait Times for Psychotherapy
A study testing UKADO Content - problem-focused, UKADO Content - resource-focused and Human support in people with Depressive Disorders and Anxiety Disorders, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorders, Anxiety Disorders
- What is being tested?
- UKADO Content - problem-focused, UKADO Content - resource-focused and Human support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Berger, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Clinical Psychology and Psychotherapy, University of Bern
Bern
About this study
Official title: 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.
- Conditions
- Depressive Disorders, Anxiety Disorders
- Being tested
- UKADO Content - problem-focused, UKADO Content - resource-focused, Human support, Expectation fostering elements
- Keywords
- OPTIBRIEF, Ultra-brief treatment, Anxiety, Depression, Factorial trial, Wait time, Psychotherapy
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UKADO Content - problem-focusedBehavioural
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 Content - resource-focusedBehavioural
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 supportBehavioural
Human support is provided as two weeks of guidance for study participants
Expectation fostering elementsBehavioural
Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.
| Study group | Role | What they receive |
|---|---|---|
| Problem-focused content | Experimental | Problem-focused condition of UKADO without human support or expectation fostering elements Receives: Behavioral: UKADO Content - problem-focused |
| Problem-focused content and expectation fostering elements | Experimental | Problem-focused condition of UKADO without human support but with expectation fostering elements Receives: Behavioral: UKADO Content - problem-focused; Behavioral: Expectation fostering elements |
| Problem-focused content and human support | Experimental | Problem-focused condition of UKADO with human support but no expectation fostering elements Receives: Behavioral: UKADO Content - problem-focused; Behavioral: Human support |
| Problem-focused content + human support + expectation fostering elements | Experimental | Problem-focused condition of UKADO with human support and expectation fostering elements Receives: Behavioral: UKADO Content - problem-focused; Behavioral: Human support; Behavioral: Expectation fostering elements |
| Resource-focused content | Experimental | Resource-focused condition of UKADO without human support and without expectation fostering elements Receives: Behavioral: UKADO Content - resource-focused |
| Resource-focused content and expectation fostering elements | Experimental | Resource-focused condition of UKADO without human support but with expectation fostering elements Receives: Behavioral: UKADO Content - resource-focused; Behavioral: Expectation fostering elements |
| Resource-focused content and human support | Experimental | Resource-focused condition of UKADO with human support but without expectation fostering elements Receives: Behavioral: UKADO Content - resource-focused; Behavioral: Human support |
| Resource-focused content + human support + expectation fostering elements | Experimental | Resource-focused condition of UKADO with human support and with expectation fostering elements Receives: Behavioral: UKADO Content - resource-focused; Behavioral: Human support; Behavioral: Expectation fostering elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At two weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, two weeks, 5 weeks, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start22 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Laura Luisa Bielinski, PhD, Principal investigator, Department of Clinical Psychology and Psychotherpay, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167849
- Sponsor's protocol ID
- 2025-00844
- Other IDs
- HumRes67051, BASEC2025-00844, SNCTP000006475, 2025
- Acronym
- OPTIBRIEF
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07167849
- Acronym / sponsor ID
- OPTIBRIEF / 2025-00844
- Conditions
- Depressive Disorders, Anxiety Disorders
- Keywords
- OPTIBRIEF, Ultra-brief treatment, Anxiety, Depression, Factorial trial, Wait time, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Macquarie University, Australia
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Problem-focused content | Experimental | Behavioral: UKADO Content - problem-focusedProblem-focused condition of UKADO without human support or expectation fostering elements |
| Problem-focused content and expectation fostering elements | Experimental | Behavioral: UKADO Content - problem-focused, Behavioral: Expectation fostering elementsProblem-focused condition of UKADO without human support but with expectation fostering elements |
| Problem-focused content and human support | Experimental | Behavioral: UKADO Content - problem-focused, Behavioral: Human supportProblem-focused condition of UKADO with human support but no expectation fostering elements |
| Problem-focused content + human support + expectation fostering elements | Experimental | Behavioral: UKADO Content - problem-focused, Behavioral: Human support, Behavioral: Expectation fostering elementsProblem-focused condition of UKADO with human support and expectation fostering elements |
| Resource-focused content | Experimental | Behavioral: UKADO Content - resource-focusedResource-focused condition of UKADO without human support and without expectation fostering elements |
| Resource-focused content and expectation fostering elements | Experimental | Behavioral: UKADO Content - resource-focused, Behavioral: Expectation fostering elementsResource-focused condition of UKADO without human support but with expectation fostering elements |
| Resource-focused content and human support | Experimental | Behavioral: UKADO Content - resource-focused, Behavioral: Human supportResource-focused condition of UKADO with human support but without expectation fostering elements |
| Resource-focused content + human support + expectation fostering elements | Experimental | Behavioral: UKADO Content - resource-focused, Behavioral: Human support, Behavioral: Expectation fostering elementsResource-focused condition of UKADO with human support and with expectation fostering elements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UKADO Content - problem-focusedUKADO 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 | Behavioural | Problem-focused content, Problem-focused content + human support + expectation fostering elements, Problem-focused content and expectation fostering elements, Problem-focused content and human support |
| UKADO Content - resource-focusedUKADO 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. | Behavioural | Resource-focused content, Resource-focused content + human support + expectation fostering elements, Resource-focused content and expectation fostering elements, Resource-focused content and human support |
| Human supportHuman support is provided as two weeks of guidance for study participants | Behavioural | Problem-focused content + human support + expectation fostering elements, Problem-focused content and human support, Resource-focused content + human support + expectation fostering elements, Resource-focused content and human support |
| Expectation fostering elementsPatient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations. | Behavioural | Problem-focused content + human support + expectation fostering elements, Problem-focused content and expectation fostering elements, Resource-focused content + human support + expectation fostering elements, Resource-focused content and expectation fostering elements |
Primary outcome
Depression and anxiety symptom severity assessed by the PHQ-ADS
Time frame: At two weeks
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.
10 secondary outcomes
Depression and anxiety symptom severity assessed by the PHQ-ADS
Time frame: 5 weeks, 9 weeks
Depression and anxiety symptom severity assessed by the PHQ-ADS
Time frame: 24 weeks
Depression symptom severity
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.
Anxiety symptom severity
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
Quality of life (EQ-5D-5L)
Time frame: Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks
Satisfaction with treatment
Time frame: two weeks
Negative effects
Time frame: 2 weeks, 5 weeks, 9 weeks, 24 weeks
Resource activation and problem mastery
Time frame: 2 weeks, 5 weeks, 9 weeks
Therapeutic alliance
Time frame: 2 weeks, 5 weeks, 9 weeks
Treatment expectations
Time frame: Baseline, two weeks, 5 weeks, 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Berger, PhD contact
Laura Luisa Bielinski, PhD principal investigator
Department of Clinical Psychology and Psychotherpay, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UKADO Content - problem-focused, UKADO Content - resource-focused and Human support in people with Depressive Disorders and Anxiety Disorders, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Luisa Bielinski, PhD (+41 31 684 39 37, laura.bielinski@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and anxiety symptom severity assessed by the PHQ-ADS (time frame: At two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.