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

Официальное название

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)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Depression and anxiety symptom severity assessed by the PHQ-ADS [Срок оценки: At two weeks]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Department of Clinical Psychology and Psychotherapy, University of Bern — Bern

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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