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Brief transdiagnostic blended therapy for emotional disorders: a waitlist-controlled pilot study

Brief transdiagnostic blended therapy for emotional disorders: a waitlist-controlled pilot study - TONI compact

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037810
Enrollment
80
Registered
2025-09-18
Start date
2025-11-11
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression (current depressive episode or recurrent) Anxiety disorder (panic disorder, agora phobia, GAS, social anxiety disorder, specific phobia) Adjustment disorder with depressed mood and/or anxiety Persistent depressive disorder F32 F33 F34.1 F41.1 F40 F43.2

Interventions

Group 1: Blended care: Study therapists will meet with eligible participants three times during the intervention period as part of the initial psychotherapeutic consultations, known as "Sprechstunden"

Sponsors

Psychologische Hochschule Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - current depressive disorder and/or anxiety disorder or adjustment disorder with depressed mood and/or anxiety based on the structured clinical interview for DSM (SCID-1) - public health insurance - ability to attend three in-person psychotherapy sessions in Berlin - stable internet connection at home and a digital device - sufficient knowledge of German - ability to read and write

Exclusion criteria

Exclusion criteria: - psychotherapy (currently or in the following 6 months) - change in psychotropic medication in the last three months - severe mental distress because of different symptoms than anxiety or depression (e.g., psychotic/manic symptoms, addiction) that cannot be managed sufficiently in the study - suicidality (score of 2 or more on item 9 of the PHQ-9 "Thoughts that you would be better off dead or of hurting yourself in some way")

Design outcomes

Primary

MeasureTime frame
Level of depression and anxiety after 10 weeks (t1) The level of depression will be assessed using the Patient Health Questionnaiere-8 (PHQ-8; Gräfe et al., 2004). The level of anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2008)

Secondary

MeasureTime frame
Loneliness (1-item "Ich fühle mich oft einsam" and UCLA-LS-3), working alliance with online-intervention (WAI-TECH-SF) and therapist (WAI-SR-P, WAI-SR-T, WAI for observers), satisfaction with life (SWLS), self-efficacy (ASK), stress (PSS-4), satisfaction with treatment (CSQ-8) Open questions: Usage (1. Welche Potenziale und Vorteile sehen Sie in der Kombination von digitalen Tools wie TONI und psychotherapeutischen Sprechstunden?; 2. Welche Grenzen und Nachteile sehen Sie in der Kombination von digitalen Tools wie TONI und psychotherapeutischen Sprechstunden?; 3. Wie viel Zeit (in Minuten pro Woche) haben Sie im Studienzeitraum im Schnitt mit der Nutzung der TONI-Plattform verbracht?) Negative effects (1. Haben Sie während des Studienzeitraums irgendwelche negativen Auswirkungen bemerkt, die Sie auf die Behandlung zurückführen würden?; 2. Wenn ja, beschreiben Sie bitte die negativen Auswirkungen in Ihren eigenen Worten; 3. Wenn ja, bewerten Sie bitte die negativen Auswirkungen auf Ihr Wohlbefinden auf einer 4-Punkte-Skala (0 = „überhaupt nicht“ bis 3 = „stark“) sowohl a) zum Zeitpunkt des Auftretens als auch b) bei der Beurteilung nach der Behandlung.) UCLA-LS-3 = UCLA Loneliness Scale 3 Items (Hughes et al., 2004; Hawkley et al., 2015) WAI-TECH-SF = Working Alliance Inventory with Online Program (Herrero et al., 2020) WAI-SR-P = Working Alliance Inventory Short Revised for Patients (Hatcher & Gillaspy, 2006; Wilmers et al., 2008) WAI-SR-T = Working Allaince Inventory Short Revised for Therapists (Hatcher & Gillaspy, 2006; Wilmers et al., 2008) SWLS = Satisfaction with Life Scale (Diener et al., 2010; Glaesmer et al., 2011) ASK = Allgemeine Selbstwirksamkeits-Skala (Beierlein et al., 2014) PSS-4 = Perceived Stress Scale-4 (Cohen et al., 1983; Warttig et al., 2014) CSQ-8 = Client Satisfaction Questionnaire-8 (Larsen et al., 1979; Schmidt et al., 2002)

Countries

Germany

Contacts

Public ContactLena Grögor

Psychologische Hochschule Berlin

l.groegor@phb.de+49 155 63 95 76 25

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026