Clinical trial NCT05221567: Intensive Psychotherapy for Chronic Depression
Official title: The Effectiveness of Intensive Psychotherapy for Chronic Depression: A Naturalistic Comparison With Treatment-as-Usual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Depression
Persistent Depressive Disorder
Recurrent Major Depression
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Depressive symptoms
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Leader Modum Bad Research Institute
name: KariAnne Vrabel, PhD
role: STUDY_DIRECTOR
References: