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

NCT ID: NCT07167849

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorders Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Problem-focused content

Problem-focused condition of UKADO without human support or expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - problem-focused

Intervention Type BEHAVIORAL

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

Problem-focused content and expectation fostering elements

Problem-focused condition of UKADO without human support but with expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - problem-focused

Intervention Type BEHAVIORAL

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

Expectation fostering elements

Intervention Type BEHAVIORAL

Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Problem-focused content and human support

Problem-focused condition of UKADO with human support but no expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - problem-focused

Intervention Type BEHAVIORAL

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

Human support

Intervention Type BEHAVIORAL

Human support is provided as two weeks of guidance for study participants

Problem-focused content + human support + expectation fostering elements

Problem-focused condition of UKADO with human support and expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - problem-focused

Intervention Type BEHAVIORAL

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

Human support

Intervention Type BEHAVIORAL

Human support is provided as two weeks of guidance for study participants

Expectation fostering elements

Intervention Type BEHAVIORAL

Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Resource-focused content

Resource-focused condition of UKADO without human support and without expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - resource-focused

Intervention Type BEHAVIORAL

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.

Resource-focused content and expectation fostering elements

Resource-focused condition of UKADO without human support but with expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - resource-focused

Intervention Type BEHAVIORAL

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.

Expectation fostering elements

Intervention Type BEHAVIORAL

Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Resource-focused content and human support

Resource-focused condition of UKADO with human support but without expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - resource-focused

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Human support is provided as two weeks of guidance for study participants

Resource-focused content + human support + expectation fostering elements

Resource-focused condition of UKADO with human support and with expectation fostering elements

Group Type EXPERIMENTAL

UKADO Content - resource-focused

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Human support is provided as two weeks of guidance for study participants

Expectation fostering elements

Intervention Type BEHAVIORAL

Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Human support

Human support is provided as two weeks of guidance for study participants

Intervention Type BEHAVIORAL

Expectation fostering elements

Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Macquarie University, Australia

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Luisa Bielinski, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherpay, University of Bern

Locations

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Department of Clinical Psychology and Psychotherapy, University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Laura Luisa Bielinski, PhD

Role: CONTACT

+41 31 684 39 37

Thomas Berger, PhD

Role: CONTACT

Other Identifiers

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2025-00844

Identifier Type: -

Identifier Source: org_study_id

HumRes67051

Identifier Type: REGISTRY

Identifier Source: secondary_id

BASEC2025-00844

Identifier Type: REGISTRY

Identifier Source: secondary_id

SNCTP000006475

Identifier Type: REGISTRY

Identifier Source: secondary_id

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