DepressionDFrontNCT04911829
Dysthymia: Associated Costs, Treatment and Change Process
A study testing Psychotherapy in people with Depression and Cost Benefit Analysis, run by Modum Bad at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Cost Benefit Analysis, Psychotherapeutic Processes
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Modum Bad
Vikersund, Buskerud, 3370
Pål G Ulvenes, PhD, 32749857, pal.ulvenes@modum-bad.no
Terje Tilden, PhD, 32749800, terje.tilden@modum-bad.no
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychotherapy
- Keywords
- Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression
- Medical subject headings
- Depression, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Inpatient treatment | Active comparator | High intensity high dosage inpatient short-term psychodynamic psychotherapy Receives: Behavioral: Psychotherapy |
| Outpatient treatment | Experimental | Low dosage outpatient short-term psychodynamic psychotherapy Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive symptoms
Beck depression inventory
Measured: 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
Measured: 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.
Measured: pre therapy, one-year and 10 years
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Once every week for the 12 weeks of active psychotherapy
anxiety Symptoms
weekly measures of Generalized Anxiety Disorders 7-item (GAD7)
Measured: 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).
Measured: 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).
Measured: 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
Measured: Once every week for the 12 weeks of active psychotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pål Ulvenes, PhD, Principal investigator, Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911829
- Sponsor's protocol ID
- Depression Forefront
- Acronym
- DFront
- Status last verified
- May 2021
- First submitted
- 15 May 2017
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DepressionForefront: Costs, Treatment and Change Process for Dysthymia
- ClinicalTrials.gov ID
- NCT04911829
- Acronym / sponsor ID
- DFront / Depression Forefront
- Keywords
- Dysthymia, Persistent depressive disorder, Chronic depression, Recurrent depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient treatment | Active comparator | Behavioral: PsychotherapyHigh intensity high dosage inpatient short-term psychodynamic psychotherapy |
| Outpatient treatment | Experimental | Behavioral: PsychotherapyLow dosage outpatient short-term psychodynamic psychotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy | Behavioural | Inpatient treatment, Outpatient treatment |
Primary outcome
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.
11 secondary outcomes
Emotional psychological processes
Time frame: Once every week for the 12 weeks of active psychotherapy
cognitive psychological processes
Time frame: Once every week for the 12 weeks of active psychotherapy
metacognitive psychological processes
Time frame: Once every week for the 12 weeks of active psychotherapy
Common factors-alliance
Time frame: Once every week for the 12 weeks of active psychotherapy
Common factors-expectations
Time frame: Once every week for the 12 weeks of active psychotherapy
Common factors-credibility
Time frame: Once every week for the 12 weeks of active psychotherapy
Common factors-explanation
Time frame: Once every week for the 12 weeks of active psychotherapy
anxiety Symptoms
Time frame: Once every week for the 12 weeks of active psychotherapy
resilience
Time frame: Once every week for the 12 weeks of active psychotherapy
loneliness
Time frame: Once every week for the 12 weeks of active psychotherapy
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: Once every week for the 12 weeks of active psychotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pål Ulvenes, PhD principal investigator
Modum Bad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Depression and Cost Benefit Analysis, run by Modum Bad at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pål Ulvenes, PhD (32749857, pal.ulvenes@modum-bad.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021; AzTrials last refreshed its copy on 26 Oct 2026.