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Increasing the Effectiveness of Psychotherapy in Routine Care through Blended Care with Transdiagnostic Online Modules (PsyTOM): Randomized Controlled Trial

Increasing the Effectiveness of Psychotherapy in Routine Care through Blended Care with Transdiagnostic Online Modules (PsyTOM): Randomized Controlled Trial - PsyTOM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028536
Enrollment
1152
Registered
2022-06-07
Start date
2022-06-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

With its transdiagnostic and modular approach, the intervention should be suitable for a wide range of complaints. Psychotherapists decide which of their patients to include in the study. In principle, all ICD-10 diagnoses from Chapter V (F00-F99) are eligible.

Interventions

Group 1: Blended Care (Psychotherapy and online intervention) Group 2: Routine Psychotherapy (Psychotherapy without online intervention)

Sponsors

Freie Universität Berlin, FB Erziehungswissenschaft und Psychologie, AB Klinisch-psychologische Intervention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Psychotherapists must be part of the contractual psychotherapeutic care and have Internet access in their practice. Their patients must be over 18 years old, have Internet access, and have sufficient German, writing, and reading skills.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
Psychological distress, as measured by the composite score of the PHQ-8 and GAD-7, at 6-months post-randomization

Secondary

MeasureTime frame
These constructs are assessed in patients with the following questionnaires at these time points: Life satisfaction: SWLS, baseline, 6 weeks, 12 weeks, 6 months, 12 months. Level of functioning: AQoL-8D; baseline, 6 weeks, 12 weeks, 6 months, 12 months Eating pathology/body image: EDE-Q8; baseline, 6 months, 12 months Alcohol use: AUDIT-C; baseline, 6 months, 12 months Drug use: DUDIT-C; baseline, 6 months, 12 months Sexual difficulties: MGH; baseline, 6 months, 12 months Personality: PID5BF+ & OPD; baseline, 6 months, 12 months Satisfaction with treatment: CSQ; 6 months. Negative effects: NEQ; 6 months Change Rating: selbst-formulated; 6 months, 12 months Utilization of health services: FIMPsy; baseline, 6 months, 12 months Usability & usage intervention: SUS; 6 months Self-efficacy: ASKU & MHSES; baseline, 6 weeks, 12 weeks, 6 months, 12 months Empowerment: 2 open-ended questions Therapeutic agency: TAI; 6 weeks, 12 weeks, 6 months Therapeutic alliance: WAI; 6 weeks, 12 weeks, 6 months Therapeutic techniques of the therapist: CPPS; 6 weeks, 12 weeks Interactional behavior of therapist: MULTI (common factors subscale); 6 weeks, 12 weeks If their psychotherapists activates this functionality, patients receiving blended care also complete the SRS and ORS for each face-to-face session. These constructs will be assessed in psychotherapists using the following questionnaires at these time points: Symptoms and Changes: CGI-S & CGI-C; baseline, 6 weeks, 12 weeks, 6 months, 12 months. Therapeutic alliance: WAI; 6 weeks, 12 weeks, 6 months Negative effects: NEQ; 6 months Usability & usage intervention: SUS & open-ended questions; 6 months These constructs will be assessed in patients' signicant others with the following questionnaires at these time points: Patient symptom distress: PHQ-8 & GAD-7; baseline, 6 months own symptom distress: PHQ-8 & GAD-7; baseline, 6 months Impact of caring for the patient: IEQ; baseline, 6 months Negative effec

Countries

Germany

Contacts

Public ContactChristine Knaevelsrud

Freie Universität BerlinFB Erziehungswissenschaft und PsychologieAB Klinisch-psychologische Intervention

christine.knaevelsrud@fu-berlin.de+49 30 838 55736

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026