Clinical trial NCT04911829: Dysthymia: Associated Costs, Treatment and Change Process
Official title: DepressionForefront: Costs, Treatment and Change Process for Dysthymia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Cost Benefit Analysis
Psychotherapeutic Processes
Keywords: Dysthymia
Persistent depressive disorder
Chronic depression
Recurrent depression
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Inpatient treatment allows a more intensive treatment and allows the patient to be in a context where it is possible to focus on the processes in therapy with minimal interruption. Outpatient treatment is much less intensive but allows the treatment process to unfold in the context where the patient is experiencing the problems that brought them to therapy. It is not clear which of the contexts will be more effective in alleviating symptoms of dysthymia. Further, as dysthymia is a very costly disease for society it is of interest to know if the two treatments are cost-effective, and which one is the most cost effective.

A great paucity on dysthymia research ha left the psychotherapy field without an understanding of the processes through which dysthymia is changed. This study will investigate the change process through frequent assessments of common factors, psychological processes, symptoms, heart rate variability and cognitive attention bias.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.

Primary outcomes:
measure: Change in Depressive symptoms
timeFrame: 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).
measure: Change in Depressive symptoms
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Change in Cost of living with dysthymia
timeFrame: pre therapy, one-year and 10 years
Secondary outcomes:
measure: Emotional psychological processes
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: cognitive psychological processes
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: metacognitive psychological processes
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Common factors-alliance
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Common factors-expectations
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Common factors-credibility
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Common factors-explanation
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: anxiety Symptoms
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: resilience
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: loneliness
timeFrame: Once every week for the 12 weeks of active psychotherapy
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: Once every week for the 12 weeks of active psychotherapy
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
affiliation: Modum Bad
name: Pål Ulvenes, PhD
role: PRINCIPAL_INVESTIGATOR
References: