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Trial record 2 of 118 for:    Dysthymia

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

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.

Condition or disease Intervention/treatment Phase
Depression Cost Benefit Analysis Psychotherapeutic Processes Behavioral: Psychotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: DepressionForefront: Costs, Treatment and Change Process for Dysthymia
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inpatient treatment
High intensity high dosage inpatient short-term psychodynamic psychotherapy
Behavioral: Psychotherapy
Experimental: Outpatient treatment
Low dosage outpatient short-term psychodynamic psychotherapy
Behavioral: Psychotherapy



Primary Outcome Measures :
  1. 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

  2. Change in Depressive symptoms [ Time Frame: Once every week for the 12 weeks of active psychotherapy ]
    Patient health questionnaire

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. anxiety Symptoms [ Time Frame: Once every week for the 12 weeks of active psychotherapy ]
    weekly measures of Generalized Anxiety Disorders 7-item (GAD7)

  9. 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).

  10. 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).

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911829


Contacts
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Contact: Pål Ulvenes, PhD 32749857 pal.ulvenes@modum-bad.no
Contact: Linne Melsom, Cand.Psy 32749700 linne.melsom@modum-bad.no

Locations
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Norway
Modum Bad Recruiting
Vikersund, Buskerud, Norway, 3370
Contact: Pål G Ulvenes, PhD    32749857    pal.ulvenes@modum-bad.no   
Contact: Terje Tilden, PhD    32749800    terje.tilden@modum-bad.no   
Principal Investigator: Pål G Ulvenes, PhD         
Sub-Investigator: Asle Hoffart, PhD         
Sub-Investigator: Bruce E Wampold, PhD         
Sponsors and Collaborators
Modum Bad
Investigators
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Principal Investigator: Pål Ulvenes, PhD Modum Bad
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Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT04911829    
Other Study ID Numbers: Depression Forefront
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Keywords provided by Modum Bad:
Dysthymia
Persistent depressive disorder
Chronic depression
Recurrent depression
Additional relevant MeSH terms:
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Depression
Dysthymic Disorder
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders