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

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Psychotherapeutic Processes; Cost Benefit Analysis
• Intervention / Treatment: Behavioral: Psychotherapy

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: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pål Ulvenes, PhD; Phone Number: 32749857; Email: pal.ulvenes@modum-bad.no
• Study Contact Backup: Name: Linne Melsom, Cand.Psy; Phone Number: 32749700; Email: linne.melsom@modum-bad.no

Study Locations

• Norway
  • Buskerud
    • Vikersund, Buskerud, Norway, 3370
      • Recruiting
      • Modum Bad
      • Contact: Pål G Ulvenes, PhD; Phone Number: 32749857; Email: pal.ulvenes@modum-bad.no
      • Contact: Terje Tilden, PhD; Phone Number: 32749800; Email: terje.tilden@modum-bad.no
      • Principal Investigator: Pål G Ulvenes, PhD
      • Sub-Investigator: Asle Hoffart, PhD
      • Sub-Investigator: Bruce E Wampold, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Modum Bad
• Investigators: Principal Investigator: Pål Ulvenes, PhD, Modum Bad

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (ACTUAL): June 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Dysthymia; Persistent depressive disorder; Recurrent depression; Chronic depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depressive Disorder; Depression; Dysthymic Disorder
• Other Study ID Numbers: Depression Forefront