Chronic DepressionNCT05221567
Intensive Psychotherapy for Chronic Depression
A study testing Psychotherapy in people with Chronic Depression and Persistent Depressive Disorder, run by Modum Bad.
Trial summary
The study evaluates whether Intensive psychotherapy show superior effect on chronic depression over TAU Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Depression, Persistent Depressive Disorder, Recurrent Major Depression
- 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
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 which includes patients with the characteristics of chronic depression (CD), thus including patients with
- Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5)
- Recurrent depressive disorder as defined by the International classification of diseases-10 (ICD-10)
Who cannot join
- Not having utilized reasonably available treatment in proximity to their residence
- A psychotic disorder
- Cluster A or B personality disorder
- Bipolar disorder,
- Ongoing substance abuse,
- Physical brain disorder
- Not having access to TAU while on the 12 week wait-list period.
About this study
Official title: The Effectiveness of Intensive Psychotherapy for Chronic Depression: A Naturalistic Comparison With Treatment-as-Usual
The study evaluates whether Intensive psychotherapy show superior effect on chronic depression over TAU
Read the detailed description
Background: Accumulating evidence indicates that intensive psychotherapy (i.e., greater number of treatment sessions per time unit) improves outcomes for patients with mental health problems. However, few studies have investigated whether patients with chronic depression (CD) benefit from treatment with higher intensity. The main purpose of this study is to investigate if intensive psychotherapy could improve treatment for patients with chronic depression (CD). The primary research question is whether two intensive psychodynamic inpatient treatments, affect phobia therapy (APT) and VITA, are superior to low intensity treatment (TAU) at completion of treatment. To indicate if a potential difference between intensive treatment and TAU is due to the intensity of the therapy, the study contrasts two therapies with similar intensity, but different theoretical rationales. Methods: 280 patients with CD are included in a naturalistic study. Patients are assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons are performed with patients matched across groups; Intensive treatment (APT + VITA) vs TAU during treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure is the BDI-II.
- Being tested
- Psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)
| Study group | Role | What they receive |
|---|---|---|
| High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy) | Active comparator | APT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use. Receives: Behavioral: Psychotherapy |
| Treatment-as-usual | Other | TAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner. Receives: Behavioral: Psychotherapy |
| High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA) | Active comparator | APT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use. 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 II (BDI-II) Self-report instrument for assessing severity of depression. 21 items are scored on Likert scale from 0 to 4 (range 0-63). Scores between 14 and 19 indicate mild depression, 20 to 28 indicate moderate depression, and above 29 indicate major depression.
Measured: Patients were assessed at four time points; assessment, start of therapy (12 weeks after assessment), end of therapy (24 weeks after assessment) and at 1-year follow-up (76 weeks after assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KariAnne Vrabel, PhD, Study director, Leader Modum Bad Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221567
- Sponsor's protocol ID
- ModumBad chronic depression
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eielsen M, Ulvenes PG, Rossberg JI, Hostmaelingen A, Soma CS, Wampold BE. The Effectiveness of an Intensive Inpatient Psychotherapy Program for Chronic Depression: A naturalistic comparison with wait list. BMC Psychiatry. 2022 Nov 30;22(1):745. doi: 10.1186/s12888-022-04381-5.
PubMed 36451114
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intensive Psychotherapy for Chronic Depression: A Naturalistic Comparison With Treatment-as-Usual
- ClinicalTrials.gov ID
- NCT05221567
- Acronym / sponsor ID
- ModumBad chronic depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Feb 2022 (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 whether Intensive psychotherapy show superior effect on chronic depression over TAU
Detailed description
Background: Accumulating evidence indicates that intensive psychotherapy (i.e., greater number of treatment sessions per time unit) improves outcomes for patients with mental health problems. However, few studies have investigated whether patients with chronic depression (CD) benefit from treatment with higher intensity. The main purpose of this study is to investigate if intensive psychotherapy could improve treatment for patients with chronic depression (CD). The primary research question is whether two intensive psychodynamic inpatient treatments, affect phobia therapy (APT) and VITA, are superior to low intensity treatment (TAU) at completion of treatment. To indicate if a potential difference between intensive treatment and TAU is due to the intensity of the therapy, the study contrasts two therapies with similar intensity, but different theoretical rationales. Methods: 280 patients with CD are included in a naturalistic study. Patients are assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons are performed with patients matched across groups; Intensive treatment (APT + VITA) vs TAU during treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure is the BDI-II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy) | Active comparator | Behavioral: PsychotherapyAPT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use. |
| Treatment-as-usual | Other | Behavioral: PsychotherapyTAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner. |
| High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA) | Active comparator | Behavioral: PsychotherapyAPT and VITA psychotherapy was carried out in accordance with treatment manuals. In addition to weekly individual sessions the inpatient program at both groups contained two 75 min group sessions each week. In addition, VITA had shorter group meetings each morning (15 minutes). Patients in both treatments participated in two physical exercise sessions per week, weekly psycho-educational lectures and art-therapy groups, and both groups finish each week with end of the week status groups. On average, patients in both treatments received seven sessions of therapeutic activity each week. All treatment components, with the exception of the physical exercises, adhered to the APT or VITA treatments, and thus the two intensive treatments were similar in dose but different in content. Medication was managed by psychiatrists, aiming to optimize the psychotropic medication regime, typically by reducing medication use. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site which includes patients with the characteristics of chronic depression (CD), thus including patients with
- Persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (DSM5)
- Recurrent depressive disorder as defined by the International classification of diseases-10 (ICD-10)
Key exclusion criteria (7 listed)
- Not having utilized reasonably available treatment in proximity to their residence
- A psychotic disorder
- Cluster A or B personality disorder
- Bipolar disorder,
- Ongoing 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 |
|---|---|---|
| PsychotherapyIntensive psychotherapy (i.e., greater number of treatment sessions per time unit) | Behavioural | High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA), High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy), Treatment-as-usual |
Primary outcome
Change in Depressive symptoms
Time frame: Patients were assessed at four time points; assessment, start of therapy (12 weeks after assessment), end of therapy (24 weeks after assessment) and at 1-year follow-up (76 weeks after assessment).
Beck depression inventory II (BDI-II) Self-report instrument for assessing severity of depression. 21 items are scored on Likert scale from 0 to 4 (range 0-63). Scores between 14 and 19 indicate mild depression, 20 to 28 indicate moderate depression, and above 29 indicate major depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 36451114Eielsen M, Ulvenes PG, Rossberg JI, Hostmaelingen A, Soma CS, Wampold BE. The Effectiveness of an Intensive Inpatient Psychotherapy Program for Chronic Depression: A naturalistic comparison with wait list. BMC Psychiatry. 2022 Nov 30;22(1):745. doi: 10.1186/s12888-022-04381-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
KariAnne Vrabel, PhD study director
Leader Modum Bad Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Chronic Depression and Persistent Depressive Disorder, run by Modum Bad.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive symptoms (time frame: Patients were assessed at four time points; assessment, start of therapy (12 weeks after assessment), end of therapy (24 weeks after assessment) and at 1-year follow-up (76 weeks after assessment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221567, which also lists 1 linked publication.
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 Feb 2022; AzTrials last refreshed its copy on 28 Oct 2026.