Dysthymia: Associated Costs, Treatment and Change Process

Depression Clinical Trial

— DFront  

Official title:

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911829
• Other study ID #: Depression Forefront
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: May 2021
• Source: Modum Bad
• Contact: Pål Ulvenes, PhD
• Phone: 32749857
• Email: pal.ulvenes[@]modum-bad.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Dysthymic Disorder
• Psychotherapeutic Processes

Intervention

Behavioral:
• Psychotherapy

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund	Buskerud

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depressive symptoms	Beck depression inventory	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).
Primary	Change in Depressive symptoms	Patient health questionnaire	Once every week for the 12 weeks of active psychotherapy
Primary	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.	pre therapy, one-year and 10 years
Secondary	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).	Once every week for the 12 weeks of active psychotherapy
Secondary	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).	Once every week for the 12 weeks of active psychotherapy
Secondary	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).	Once every week for the 12 weeks of active psychotherapy
Secondary	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).	Once every week for the 12 weeks of active psychotherapy
Secondary	Common factors-expectations	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).	Once every week for the 12 weeks of active psychotherapy
Secondary	Common factors-credibility	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).	Once every week for the 12 weeks of active psychotherapy
Secondary	Common factors-explanation	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).	Once every week for the 12 weeks of active psychotherapy
Secondary	anxiety Symptoms	weekly measures of Generalized Anxiety Disorders 7-item (GAD7)	Once every week for the 12 weeks of active psychotherapy
Secondary	resilience	weekly measures of resilience (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).	Once every week for the 12 weeks of active psychotherapy
Secondary	loneliness	weekly measures of loneliness (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).	Once every week for the 12 weeks of active psychotherapy
Secondary	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)	weekly measures of wellbeing. 14 Items scored 1-5 (Total score from 14-70). Higher score is better	Once every week for the 12 weeks of active psychotherapy