Health TrialsbyHealthPanel

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

ConditionsDepressive DisordersAnxiety Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Factorial

Treatments tested in this trial

  • UKADO Content - problem-focused

    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

  • UKADO Content - resource-focused

    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

    Behavioral

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

  • Expectation fostering elements

    Behavioral

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

Treatment groups

312 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Problem-focused contentExperimental treatment 1 intervention
Group B: Problem-focused content and expectation fostering elementsExperimental treatment 2 interventions
Group C: Problem-focused content and human supportExperimental treatment 2 interventions
Group D: Problem-focused content + human support + expectation fostering elementsExperimental treatment 3 interventions
Group E: Resource-focused contentExperimental treatment 1 intervention
Group F: Resource-focused content and expectation fostering elementsExperimental treatment 2 interventions
Group G: Resource-focused content and human supportExperimental treatment 2 interventions
Group H: Resource-focused content + human support + expectation fostering elementsExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
At two weeks

Secondary 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 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.

Time frame
5 weeks, 9 weeks
2

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.

Time frame
24 weeks
3

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).

Time frame
Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.
4

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)

Time frame
Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks

Other outcomes

1

Patient experience interviews

Qualitative interviews conducted with a subset of participants using a study-specific guide developed to explore participants' experiences with the intervention.

Time frame
9 weeks
2

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)

Time frame
24 weeks
3

UBT uptake

Uptake of the UBT will be assessed at 2 weeks by reporting the number of patients who used the UBT (logged in).

Time frame
2 weeks
4

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.

Time frame
2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

Macquarie University, Australia

Collaborator

Source ClinicalTrials.gov
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