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

Not Applicable

Not yet recruiting

• Conditions: Depressive Disorders; Anxiety Disorders

• Registration Number: NCT07167849
• Lead Sponsor: University of Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 312

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Depression and anxiety symptom severity assessed by the PHQ-ADS	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.

Secondary Outcome Measures

Name	Time	Method
Negative effects	2 weeks, 5 weeks, 9 weeks, 24 weeks	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.
Depression and anxiety symptom severity assessed by the PHQ-ADS	24 weeks	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.
Therapeutic alliance	2 weeks, 5 weeks, 9 weeks	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.
Treatment expectations	Baseline, two weeks, 5 weeks, 9 weeks	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.
Depression symptom severity	Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks.	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).
Anxiety symptom severity	Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks	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)
Quality of life (EQ-5D-5L)	Baseline, 2 weeks, 5 weeks, 9 weeks, 24 weeks	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).
Satisfaction with treatment	two weeks	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).
Resource activation and problem mastery	2 weeks, 5 weeks, 9 weeks	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.

Trial Locations

Locations (1)

Department of Clinical Psychology and Psychotherapy, University of Bern; 🇨🇭 Bern, Switzerland