Dysthymia: Associated Costs, Treatment and Change Process

Study Overview
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Brief Summary
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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
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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.

Official Title
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DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Conditions
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Depression, Cost Benefit Analysis, Psychotherapeutic Processes

Intervention / Treatment
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* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient treatment<br>High intensity high dosage inpatient short-term psychodynamic psychotherapy | Behavioral: Psychotherapy<br> <br> |
| Experimental: Outpatient treatment<br>Low dosage outpatient short-term psychodynamic psychotherapy | Behavioral: Psychotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| Change in Depressive symptoms | Patient health questionnaire | Once every week for the 12 weeks of active psychotherapy | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| anxiety Symptoms | weekly measures of Generalized Anxiety Disorders 7-item (GAD7) | Once every week for the 12 weeks of active psychotherapy | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression