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Completed

NCT Number: NCT05221567

Intensive Psychotherapy for Chronic Depression

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

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Key information

Conditions

Chronic Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Persistent Depressive Disorder Recurrent Major Depression

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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 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.

Treatment and study plan

Psychotherapy

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

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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