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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01640483
Other study ID # EC/2012/455
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2012
Est. completion date December 2015

Study information

Verified date November 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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).

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Funding by BOF (Bijzonder Onderzoeksfonds)

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
25 weeks
Secondary 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).
25 weeks
Secondary 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).
25 weeks
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