NCT01640483

Brief Summary

Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for Major Depressive Disorder are differentially efficacious dependent on personality traits of the patient. More specifically, supportive techniques are hypothesized to be more efficacious for dependent patients, interpretative techniques to be more efficacious for self-critical patients, and mixed supportive/interpretative techniques to be more efficacious for mixed dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact on depressive symptoms through increased relational capacities while interpretative techniques impact through increased self-understanding. These hypotheses are tested in an experimental single case design with three dependent, three self-critical and three mixed dependent/self-critical depressive patients. These patients go through a time-limited (50 sessions) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

July 5, 2012

Last Update Submit

November 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in depressive symptoms at 25 weeks (50 sessions, 2 sessions/week).

    •Measures each session: The BDI-II with adapted instructions is used to measure depressive symptoms. The process variables associated with change in depressive symptoms will be studied in an exploratory way by means of Psychotherapy Process Q Set (PQS) ratings of the transcripts of the sessions. •Measures during A phases: Besides the SCID-I (session 1 and 2 of each A phase) and SCID-II (session 3 of each A phase) interviews, the therapist will administer the Depressive Experiences Questionnaire (DEQ).

    25 weeks

Secondary Outcomes (3)

  • improvement in relational capacities

    25 weeks

  • improvement in insight

    25 weeks

  • improvement in quality of life, a broad range of physical and psychological symptoms.

    25 weeks

Study Arms (3)

supportive

ACTIVE COMPARATOR
Other: psychodynamic techniques.

interpretative

ACTIVE COMPARATOR
Other: psychodynamic techniques.

mixed supportive/interpretative

ACTIVE COMPARATOR
Other: psychodynamic techniques.

Interventions

the patients go through a time-limited (50 sessions, 45 minutes, 2 sessions/week) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).

interpretativemixed supportive/interpretativesupportive

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient meets criteria for Major Depressive Disorder (as assessed by SCID-I and DSM-IV-TR)
  • Patient is prepared to give informed consent

You may not qualify if:

  • Patient uses antidepressant medication during the treatment
  • Patient scores 3 on the suicide item of the BDI-II
  • Patient meets criteria for psychotic or personality disorder (as assessed by SCID-II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Stijn Vanheule, Prof Phd

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Gilbert Lemmens, Phd MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 13, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations