NCT05221567

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

January 21, 2022

Last Update Submit

February 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (3)

High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy)

ACTIVE COMPARATOR

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

Treatment-as-usual

OTHER

TAU through public services locally, either outpatient treatment from a psychologist/psychiatrist and/or treatment/support from their local general practitioner.

Behavioral: Psychotherapy

High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA)

ACTIVE COMPARATOR

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

Interventions

PsychotherapyBEHAVIORAL

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

High intensity high dosage inpatient short-term psychodynamic psychotherapy (VITA)High intensity high dosage inpatient short-term psychodynamic psychotherapy (affect phobia therapy)Treatment-as-usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eielsen M, Ulvenes PG, Rossberg JI, Hostmaelingen A, Soma CS, Wampold BE. The Effectiveness of an Intensive Inpatient Psychotherapy Program for Chronic Depression: A naturalistic comparison with wait list. BMC Psychiatry. 2022 Nov 30;22(1):745. doi: 10.1186/s12888-022-04381-5.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • KariAnne Vrabel, PhD

    Leader Modum Bad Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 3, 2022

Study Start

January 1, 2012

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share