Intensive Psychotherapy for Chronic Depression

Not Applicable

Completed

• Conditions: Persistent Depressive Disorder; Recurrent Major Depression; Chronic Depression
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT05221567
• Lead Sponsor: Modum Bad

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2022-01-21
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy)	Psychotherapy	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.
High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA)	Psychotherapy	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.
Treatment-as-usual	Psychotherapy	TAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner.

Primary Outcome Measures

Name	Time	Method
Change in Depressive symptoms	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.