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

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ClinicalTrials.gov Identifier: NCT01640483
Recruitment Status : Unknown
Verified June 2015 by University Ghent.
Recruitment status was:  Recruiting
First Posted : July 13, 2012
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
Funding by BOF (Bijzonder Onderzoeksfonds)
Information provided by (Responsible Party):
University Ghent

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).


Condition or disease Intervention/treatment Phase
Major Depressive Disorder. Other: psychodynamic techniques. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients: an Experimental Single Case Design.
Study Start Date : December 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arm Intervention/treatment
Active Comparator: supportive Other: psychodynamic techniques.
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).

Active Comparator: interpretative Other: psychodynamic techniques.
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).

Active Comparator: mixed supportive/interpretative Other: psychodynamic techniques.
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 Measures :
  1. Reduction in depressive symptoms at 25 weeks (50 sessions, 2 sessions/week). [ Time Frame: 25 weeks ]

    •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 :
  1. improvement in relational capacities [ Time Frame: 25 weeks ]

    • 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).


  2. improvement in insight [ Time Frame: 25 weeks ]
    • 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).

  3. improvement in quality of life, a broad range of physical and psychological symptoms. [ Time Frame: 25 weeks ]

    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).




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640483


Contacts
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Contact: Shana Cornelis, Drs shana.cornelis@ugent.be

Locations
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Belgium
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Stijn Vanheule, Prof Phd    003292649101    stijn.vanheule@ugent.be   
Principal Investigator: Stijn Vanheule, Prof Phd         
Sub-Investigator: Mattias Desmet, Phd         
Sponsors and Collaborators
University Ghent
Funding by BOF (Bijzonder Onderzoeksfonds)
Investigators
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Principal Investigator: Stijn Vanheule, Prof Phd University Ghent
Principal Investigator: Gilbert Lemmens, Phd MD University Hospital, Ghent

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01640483     History of Changes
Other Study ID Numbers: EC/2012/455
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders