Dysthymia: Associated Costs, Treatment and Change Process
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorModum Bad
About this trial
The study evaluates cost and effect of inpatient versus outpatient treatment of dysthymia, as well as investigates the processes through which psychotherapy works in treating dysthymia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site: Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5); which includes an International classification of disorders-10 (ICD-10) diagnosis of depression, dysthymia, recurrent depression. unsuccessful previous treatments. living within driving distance from the treatment facilities.
Disqualifiers
current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.
Trial design
Design model
Parallel
Treatments tested in this trial
Psychotherapy
Behavioral
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Inpatient treatmentActive comparator 1 intervention
Group B: Outpatient treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Depressive symptoms
Beck depression inventory
Time frame
At assessment, start (12 weeks after assessment) and end (24 weeks after assessment) of therapy, and at one-year follow up (76 weeks after assessment).2
Change in Depressive symptoms
Patient health questionnaire
Time frame
Once every week for the 12 weeks of active psychotherapy3
Change in Cost of living with dysthymia
cost of living with dysthymia, cost-effectiveness of therapy at one-year and at 10 years. Information will be gathered from various registries and combined to a sum of money.
Time frame
pre therapy, one-year and 10 yearsSecondary outcomes
1
Emotional psychological processes
weekly measures of central emotional psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time frame
Once every week for the 12 weeks of active psychotherapy2
cognitive psychological processes
weekly measures of central cognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time frame
Once every week for the 12 weeks of active psychotherapy3
metacognitive psychological processes
weekly measures of central metacognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time frame
Once every week for the 12 weeks of active psychotherapy4
Common factors-alliance
weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time frame
Once every week for the 12 weeks of active psychotherapy Source ClinicalTrials.gov