Intensive Psychotherapy for Chronic Depression

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

Study Overview

• Status: Completed
• Conditions: Persistent Depressive Disorder; Chronic Depression; Recurrent Major Depression
• Intervention / Treatment: Behavioral: Psychotherapy

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy); 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.	Behavioral: Psychotherapy; Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)
OTHER: Treatment-as-usual; TAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner.	Behavioral: Psychotherapy; Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)
ACTIVE_COMPARATOR: High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA); 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.	Behavioral: Psychotherapy; Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Modum Bad
• Investigators: Study Director: KariAnne Vrabel, PhD, Leader Modum Bad Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (ACTUAL): February 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: ModumBad chronic depression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No