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NCT Number: NCT04911829

Dysthymia: Associated Costs, Treatment and Change Process

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Modum Bad

Vikersund, Buskerud, 3370, Norway

Location status: Recruiting

Location contact

Asle Hoffart, PhD

SUB_INVESTIGATOR

Bruce E Wampold, PhD

SUB_INVESTIGATOR

Pål G Ulvenes, PhD

CONTACT

[email protected]

32749857

Pål G Ulvenes, PhD

PRINCIPAL_INVESTIGATOR

Terje Tilden, PhD

CONTACT

[email protected]

32749800

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Behavioral

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Linne Melsom, Cand.Psy

CONTACT

[email protected]

32749700

Pål Ulvenes, PhD

CONTACT

[email protected]

32749857

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

DepressionForefront: Costs, Treatment and Change Process for Dysthymia

Acronym: DFront

Important dates

Study start
2016
Primary completion
2021
Study completion
2026
First posted
Jun 3, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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