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

Primary Purpose

Depression, Cost Benefit Analysis, Psychotherapeutic Processes

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Modum Bad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Modum BadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Inpatient treatment

Outpatient treatment

Arm Description

High intensity high dosage inpatient short-term psychodynamic psychotherapy

Low dosage outpatient short-term psychodynamic psychotherapy

Outcomes

Primary Outcome Measures

Change in Depressive symptoms
Beck depression inventory
Change in Depressive symptoms
Patient health questionnaire
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
anxiety Symptoms
weekly measures of Generalized Anxiety Disorders 7-item (GAD7)
resilience
weekly measures of resilience (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
loneliness
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)
weekly measures of wellbeing. 14 Items scored 1-5 (Total score from 14-70). Higher score is better

Full Information

First Posted
May 15, 2017
Last Updated
May 31, 2021
Sponsor
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT04911829
Brief Title
Dysthymia: Associated Costs, Treatment and Change Process
Acronym
DFront
Official Title
DepressionForefront: Costs, Treatment and Change Process for Dysthymia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modum Bad

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Cost Benefit Analysis, Psychotherapeutic Processes
Keywords
Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inpatient treatment
Arm Type
Active Comparator
Arm Description
High intensity high dosage inpatient short-term psychodynamic psychotherapy
Arm Title
Outpatient treatment
Arm Type
Experimental
Arm Description
Low dosage outpatient short-term psychodynamic psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Primary Outcome Measure Information:
Title
Change in Depressive symptoms
Description
Beck depression inventory
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).
Title
Change in Depressive symptoms
Description
Patient health questionnaire
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Change in Cost of living with dysthymia
Description
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.
Time Frame
pre therapy, one-year and 10 years
Secondary Outcome Measure Information:
Title
Emotional psychological processes
Description
weekly measures of central emotional psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
cognitive psychological processes
Description
weekly measures of central cognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
metacognitive psychological processes
Description
weekly measures of central metacognitive psychological processes (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, lower is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Common factors-alliance
Description
weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Common factors-expectations
Description
weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Common factors-credibility
Description
weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Common factors-explanation
Description
weekly measures of central common factors (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
anxiety Symptoms
Description
weekly measures of Generalized Anxiety Disorders 7-item (GAD7)
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
resilience
Description
weekly measures of resilience (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
loneliness
Description
weekly measures of loneliness (Modum Process Outcome questionnaire, M-poq. Calculated as mean of scores. Range 1-7, higher is better).
Time Frame
Once every week for the 12 weeks of active psychotherapy
Title
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Description
weekly measures of wellbeing. 14 Items scored 1-5 (Total score from 14-70). Higher score is better
Time Frame
Once every week for the 12 weeks of active psychotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pål Ulvenes, PhD
Phone
32749857
Email
pal.ulvenes@modum-bad.no
First Name & Middle Initial & Last Name or Official Title & Degree
Linne Melsom, Cand.Psy
Phone
32749700
Email
linne.melsom@modum-bad.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Ulvenes, PhD
Organizational Affiliation
Modum Bad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Modum Bad
City
Vikersund
State/Province
Buskerud
ZIP/Postal Code
3370
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pål G Ulvenes, PhD
Phone
32749857
Email
pal.ulvenes@modum-bad.no
First Name & Middle Initial & Last Name & Degree
Terje Tilden, PhD
Phone
32749800
Email
terje.tilden@modum-bad.no
First Name & Middle Initial & Last Name & Degree
Pål G Ulvenes, PhD
First Name & Middle Initial & Last Name & Degree
Asle Hoffart, PhD
First Name & Middle Initial & Last Name & Degree
Bruce E Wampold, PhD

12. IPD Sharing Statement

Learn more about this trial

Dysthymia: Associated Costs, Treatment and Change Process

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