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Dysthymia: Associated Costs, Treatment and Change Process

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04911829
Acronym
DFront
Enrollment
80
Registered
2021-06-03
Start date
2016-01-31
Completion date
2026-12-31
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cost Benefit Analysis, Depression, Psychotherapeutic Processes

Keywords

Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression

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.

Interventions

BEHAVIORALPsychotherapy

Sponsors

Modum Bad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Depressive symptomsAt assessment, start (12 weeks after assessment) and end (24 weeks after assessment) of therapy, and at one-year follow up (76 weeks after assessment).Beck depression inventory
Change in Cost of living with dysthymiapre therapy, one-year and 10 yearscost 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.

Secondary

MeasureTime frameDescription
anxiety SymptomsOnce every week for the 12 weeks of active psychotherapyweekly measures of Generalized Anxiety Disorders 7-item (GAD7)
Emotional psychological processesOnce every week for the 12 weeks of active psychotherapyweekly measures of central emotional psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
cognitive psychological processesOnce every week for the 12 weeks of active psychotherapyweekly measures of central cognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
metacognitive psychological processesOnce every week for the 12 weeks of active psychotherapyweekly measures of central metacognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Common factors-allianceOnce every week for the 12 weeks of active psychotherapyweekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Common factors-expectationsOnce every week for the 12 weeks of active psychotherapyweekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
resilienceOnce every week for the 12 weeks of active psychotherapyweekly measures of resilience (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Common factors-credibilityOnce every week for the 12 weeks of active psychotherapyweekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Common factors-explanationOnce every week for the 12 weeks of active psychotherapyweekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
lonelinessOnce every week for the 12 weeks of active psychotherapyweekly measures of loneliness (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)Once every week for the 12 weeks of active psychotherapyweekly measures of wellbeing. 14 Items scored 1-5 (Total score from 14-70). Higher score is better

Countries

Norway

Contacts

Primary ContactPål Ulvenes, PhD
pal.ulvenes@modum-bad.no32749857
Backup ContactLinne Melsom, Cand.Psy
linne.melsom@modum-bad.no32749700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026