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Recruiting NCT04911829

Dysthymia: Associated Costs, Treatment and Change Process

No phase Interventional Depression Cost Benefit Analysis Psychotherapeutic Processes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychotherapy.
Who it may be relevant to
Registry conditions: Depression, Cost Benefit Analysis, Psychotherapeutic Processes. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Overview

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

  • Behavioral Psychotherapy

Primary outcome measures

  • Change in Depressive symptoms [Time frame: 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 [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Change in Cost of living with dysthymia [Time frame: pre therapy, one-year and 10 years]
Secondary outcome measures (11)
  • Emotional psychological processes [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • cognitive psychological processes [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • metacognitive psychological processes [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Common factors-alliance [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Common factors-expectations [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Common factors-credibility [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Common factors-explanation [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • anxiety Symptoms [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • resilience [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • loneliness [Time frame: Once every week for the 12 weeks of active psychotherapy]
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [Time frame: Once every week for the 12 weeks of active psychotherapy]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Modum Bad — Vikersund

Identifiers

NCT: NCT04911829 · Depression Forefront

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗