Dysthymia: Associated Costs, Treatment and Change Process

Not Applicable

Recruiting

• Conditions: Psychotherapeutic Processes; Cost Benefit Analysis; Depression
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT04911829
• Lead Sponsor: Modum Bad

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-05-15
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-31
• Last Update Submitted: 2021-05-31
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Primary Completion: 2021-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient treatment	Psychotherapy	High intensity high dosage inpatient short-term psychodynamic psychotherapy
Outpatient treatment	Psychotherapy	Low dosage outpatient short-term psychodynamic psychotherapy

Primary Outcome Measures

Name	Time	Method
Change in Depressive symptoms	Once every week for the 12 weeks of active psychotherapy	Patient health questionnaire
Change in Cost of living with dysthymia	pre therapy, one-year and 10 years	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.

Secondary Outcome Measures

Name	Time	Method
Common factors-expectations	Once every week for the 12 weeks of active psychotherapy	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Common factors-credibility	Once every week for the 12 weeks of active psychotherapy	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Emotional psychological processes	Once every week for the 12 weeks of active psychotherapy	weekly 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 processes	Once every week for the 12 weeks of active psychotherapy	weekly 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 processes	Once every week for the 12 weeks of active psychotherapy	weekly 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-alliance	Once every week for the 12 weeks of active psychotherapy	weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Common factors-explanation	Once every week for the 12 weeks of active psychotherapy	weekly measures of central common factors (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 psychotherapy	weekly measures of wellbeing. 14 Items scored 1-5 (Total score from 14-70). Higher score is better
resilience	Once every week for the 12 weeks of active psychotherapy	weekly measures of resilience (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
anxiety Symptoms	Once every week for the 12 weeks of active psychotherapy	weekly measures of Generalized Anxiety Disorders 7-item (GAD7)
loneliness	Once every week for the 12 weeks of active psychotherapy	weekly measures of loneliness (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).

Trial Locations

Locations (1)

Modum Bad; 🇳🇴 Vikersund, Buskerud, Norway