F32.1 F32.2 F32.3 F33.1 F33.2 F33.3 F34.1 F40.00 F40.01 F40.1 F40.2 F41.0 F41.1 F41.2 F41.3
Conditions
Interventions
Group 1: PSYCHOnlineTHERAPYfix: max. 16 CBT-based sessions in a fixed order alternating an online-intervention module followed by a standard psychotherapy session (PNP-based).
Group 2: PSYCHOnlineTHER
Sponsors
Abteilung Klinische Psychologie und Psychotherapie, Universität Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression and anxiety symptoms at all other assessments will be considered as secondary outcome. Additional secondary outcomes: Depression and anxiety remission will be assessed with the Structured Clinical Interview (SCID-5); Depression response will be assessed with the Quick Inventory of Depressive Symptomatology (QIDS); Anxiety response will be assessed with the Hamilton Anxiety Rating Scale (HAM-A); Health-related quality of life will be assessed with the self-report questionnaire Assessment of Quality of Life (AQoL-8D); Patient satisfaction will be assessed with a German short version (ZUF-8) of the Client Satisfaction Questionnaire (CSQ); Working alliance will be assessed with the German version of the Working Alliance Inventory (WAI-SR), participants will complete the WAI-SR at T1 and T3, therapists only at T3; Psychotherapy adherence will be assessed by means of the number of completed online- and standard sessions and “per protocol” adherence is operationalized by the percentage of participants that completed their psychotherapy as recommended by their therapist. Reasons for dropout are assessed by 6 Items at post treatment (T3). Covariates: As potential moderating variables, demographic (e.g. gender, age, education) and medical information (e.g. previous treatment, medication) will be recorded at baseline. Further, a variety of potential predictors will be included to assess moderators and mediators of psychotherapy effects. The following information of therapists will be assessed with 7 items: age, gender, time since completing clinical training, number of inhabitants at the location of the practice, and experience with digitally supported psychotherapy. Further patient characteristics (risk factors) that potentially predict depression and anxiety symptoms will be assessed by means of 26 self-report items. The following factors will be assessed: smoking, drug use, alcohol consumption, diet quality, social status, minority, discrimination, self-percei | — |
Countries
Germany
Contacts
Public ContactAnna-Carlotta Zarski
Abteilung Klinische Psychologie und Psychotherapie, Friedrich-Alexander-Universität Erlangen-Nürnberg
Outcome results
None listed