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Recruiting NCT07167849

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

No phase Interventional Depressive Disorders Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UKADO Content - problem-focused, UKADO Content - resource-focused, Human support, Expectation fostering elements.
Who it may be relevant to
Registry conditions: Depressive Disorders, Anxiety Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Interventions

  • 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 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.
  • Behavioral Human support
    Human support is provided as two weeks of guidance for study participants
  • Behavioral Expectation fostering elements
    Patient in the expectation-fostering condition receive elements in UKADO that are meant to foster expectations.

Primary outcome measures

  • Depression and anxiety symptom severity assessed by the PHQ-ADS [Time frame: At two weeks]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Department of Clinical Psychology and Psychotherapy, University of Bern — Bern

Identifiers

NCT: NCT07167849 · 2025-00844 · HumRes67051 · BASEC2025-00844 · SNCTP000006475

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗