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Dysthymia: Associated Costs, Treatment and Change Process (DFront)

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ClinicalTrials.gov Identifier: NCT04911829
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Modum Bad

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE June 3, 2021
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
  • 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). ]
    Beck depression inventory
  • Change in Depressive symptoms [ Time Frame: Once every week for the 12 weeks of active psychotherapy ]
    Patient health questionnaire
  • Change in Cost of living with dysthymia [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
  • Emotional psychological processes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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-expectations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
  • anxiety Symptoms [ Time Frame: Once every week for the 12 weeks of active psychotherapy ]
    weekly measures of Generalized Anxiety Disorders 7-item (GAD7)
  • resilience [ Time Frame: 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).
  • loneliness [ Time Frame: 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).
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dysthymia: Associated Costs, Treatment and Change Process
Official Title  ICMJE DepressionForefront: Costs, Treatment and Change Process for Dysthymia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Cost Benefit Analysis
  • Psychotherapeutic Processes
Intervention  ICMJE Behavioral: Psychotherapy
Study Arms  ICMJE
  • Active Comparator: Inpatient treatment
    High intensity high dosage inpatient short-term psychodynamic psychotherapy
    Intervention: Behavioral: Psychotherapy
  • Experimental: Outpatient treatment
    Low dosage outpatient short-term psychodynamic psychotherapy
    Intervention: Behavioral: Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2021)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pål Ulvenes, PhD 32749857 pal.ulvenes@modum-bad.no
Contact: Linne Melsom, Cand.Psy 32749700 linne.melsom@modum-bad.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04911829
Other Study ID Numbers  ICMJE Depression Forefront
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Modum Bad
Study Sponsor  ICMJE Modum Bad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pål Ulvenes, PhD Modum Bad
PRS Account Modum Bad
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP