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Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients (PsychodynDep)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
psychodynamic techniques.
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

supportive

interpretative

mixed supportive/interpretative

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

improvement in relational capacities
• Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. • Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).
improvement in insight
Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).
improvement in quality of life, a broad range of physical and psychological symptoms.
Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).

Full Information

First Posted
July 5, 2012
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
Funding by BOF (Bijzonder Onderzoeksfonds)
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1. Study Identification

Unique Protocol Identification Number
NCT01640483
Brief Title
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients
Acronym
PsychodynDep
Official Title
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients: an Experimental Single Case Design.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Funding by BOF (Bijzonder Onderzoeksfonds)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supportive
Arm Type
Active Comparator
Arm Title
interpretative
Arm Type
Active Comparator
Arm Title
mixed supportive/interpretative
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
psychodynamic techniques.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in depressive symptoms at 25 weeks (50 sessions, 2 sessions/week).
Description
•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).
Time Frame
25 weeks
Secondary Outcome Measure Information:
Title
improvement in relational capacities
Description
• Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. • Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).
Time Frame
25 weeks
Title
improvement in insight
Description
Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).
Time Frame
25 weeks
Title
improvement in quality of life, a broad range of physical and psychological symptoms.
Description
Measures that are applied each session (also during A phases): The relational capacities (CDPS-RC) and insight (CDPS-IN) subscales of the Capacity for Dynamic Process Scale (CDPRS) of nine researcher-rated items. Measures that are applied during A phases: The therapist will administer the Clinical Diagnostic Interview (CDI, session 4 and 5 of each A phase),and a broad-spectrum set of self-report outcome measures, including the Symptom Check List (SCL-90-R), the Inventory of Interpersonal Problems - 64 (IIP-64), the SELVES and the Quality of Life Inventory (QOLI).
Time Frame
25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient meets criteria for Major Depressive Disorder (as assessed by SCID-I and DSM-IV-TR) Patient is prepared to give informed consent Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stijn Vanheule, Prof Phd
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilbert Lemmens, Phd MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients

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