Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: a multicenter blended outpatient psychotherapy cluster randomized controlled trial for patients with depressive and anxiety disorders

Phase 4

Recruiting

• Conditions: F33.3; F34.1; F40.00; F40.01; F32.1; F32.2; F32.3; F33.1; F33.2; F40.1

• Registration Number: DRKS00023973
• Lead Sponsor: Abteilung Klinische Psychologie und Psychotherapie, Universität Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Inclusion criteria of patients:
Psychotherapy outpatients of enrolled psychotherapists are eligible for inclusion in case of a given informed consent and if they a) are = 18 years, b) have a depressive disorder or anxiety disorder diagnosis eligible to be treated under the PNP contract (medical record of an ICD-10 F32/33.1-.3; F40.00/.01; F40.1; F40.2; F41.0-.3), c) have a health insurance contract with AOK Baden-Wuerttemberg or Bosch BKK as part of the selective PNP-contract according to §73c SGB V, d) complete the baseline assessment (online assessment and telephone-based standardized clinical interview), e) have internet-access and an internet-capable device (self-report), f) have sufficient knowledge of the German language (therapist rating), g) have no ICD-10-F2 diagnosis (therapist rating) as Internet- and mobile-based interventions are not well examined for this patient group yet, and h) show no clinical reasons for exclusion (therapist rating).

Inclusion criteria of psychotherapists:
Psychotherapists are eligible for inclusion in case of a given informed consent and if they a) are actively working as a psychological psychotherapist, a medical specialist for psychiatry and psychotherapy or psychosomatic medicine and psychotherapy, another physician working as psychotherapist, or a children and adolescent psychotherapist, b) are (employed in a practice owned by) a PNP contract partner, c) hold a CBT license, d) are available during recruitment and assessment period (self-report), e) are capable of including 12 patients into the study during the recruitment period (18 months; self-report), and f) are taking part in an one day training course with details on study and intervention protocol adherence.

Exclusion Criteria

Patients with ICD-10-F2 diagnoses are excluded. Apart from this, exclusion criteria are kept at a minimum in this effectiveness trial embedded in standard psychotherapeutic outpatient care. Suicidal tendencies are not defined as exclusion criteria and will be therapeutically handled by the treating psychotherapist according to established standards for crises interventions in standard psychotherapeutic care. In case of acute suicidal tendencies psychotherapists might judge patients as not clinically suitable for blended therapy (criterion h). Respective therapist decisions will be recorded.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is depression and anxiety severity at 18 weeks follow-up (T3), assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS).