- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640483
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients (PsychodynDep)
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients: an Experimental Single Case Design.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: supportive
|
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
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
25 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
25 weeks
|
improvement in insight
Time Frame: 25 weeks
|
|
25 weeks
|
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). |
25 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stijn Vanheule, Prof Phd, University Ghent
- Principal Investigator: Gilbert Lemmens, Phd MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2012/455
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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