The ten-item depression and anxiety symptom checklist (SCL-10) [50 (link), 71 (link)], well-being measured by WHO-5 [50 (link), 72 (link)], and disability measured by a modified Sheehan Disability Scale (mSDS) are the established treatment effect parameters by the Mental Health Services of the Capital Region of Denmark.
Tertiary endpoints are three measurements of psychosocial remission defined as a WHO-5 score of > 49, an SCL-10 score of < 26 and an mSDS score of < 10. Additional tertiary clinical endpoints are changes in wellness (WHO-5), disability (mSDS), and symptomatology on the Brief Symptom Inventory 18 (BSI-18) and the SCL-10.
Two questionnaires assessing the negative effects of psychological and antidepressant treatment will be sent at the first follow-up, at the end of the treatment package. We use the Patient-Reported Inventory of Side-Effects (PRISE), originally developed and validated in Danish and also used in the STAR*D trial [71 (link), 73 (link)]. The questionnaire is omitted if the patient has not been or is not on antidepressant medication. We use the short 20-item form of the Negative Effects Questionnaire (NEQ) to assess adverse and unwanted events in psychological treatment, i.e., new symptoms, dependency, stigma, hopelessness, and the experienced quality of treatment [74 (link), 75 (link)]. Both baseline characteristics and treatment experiences, e.g., negative effects on the NEQ, will be used to investigate reasons for CBT and treatment package drop-out.
Tertiary endpoints are three measurements of psychosocial remission defined as a WHO-5 score of > 49, an SCL-10 score of < 26 and an mSDS score of < 10. Additional tertiary clinical endpoints are changes in wellness (WHO-5), disability (mSDS), and symptomatology on the Brief Symptom Inventory 18 (BSI-18) and the SCL-10.
Two questionnaires assessing the negative effects of psychological and antidepressant treatment will be sent at the first follow-up, at the end of the treatment package. We use the Patient-Reported Inventory of Side-Effects (PRISE), originally developed and validated in Danish and also used in the STAR*D trial [71 (link), 73 (link)]. The questionnaire is omitted if the patient has not been or is not on antidepressant medication. We use the short 20-item form of the Negative Effects Questionnaire (NEQ) to assess adverse and unwanted events in psychological treatment, i.e., new symptoms, dependency, stigma, hopelessness, and the experienced quality of treatment [74 (link), 75 (link)]. Both baseline characteristics and treatment experiences, e.g., negative effects on the NEQ, will be used to investigate reasons for CBT and treatment package drop-out.
Free full text: Click here
