Intensive Psychotherapy for Chronic Depression

Persistent Depressive Disorder Clinical Trial

Official title:

The Effectiveness of Intensive Psychotherapy for Chronic Depression: A Naturalistic Comparison With Treatment-as-Usual

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221567
• Other study ID #: ModumBad chronic depression
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2022
• Source: Modum Bad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates whether Intensive psychotherapy show superior effect on chronic depression over TAU

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Depression
• Depression
• Depressive Disorder
• Persistent Depressive Disorder
• Recurrent Major Depression

Intervention

Behavioral:
• Psychotherapy
Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).