Linköping University Relational and Interpersonal Psychotherapy Project (LURIPP)
Primary Purpose
Major Depressive Disorder
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Brief Relational Therapy
Interpersonal Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depression, Interpersonal Psychotherapy, Brief Relational Therapy, Outcome research
Eligibility Criteria
Inclusion Criteria:
- Major Depressive Disorder (DSM-IV)
- Hamilton Depression Rating Scale (17-item version) score 20 or greater
Exclusion Criteria:
- Any psychotic disorder
- Substance abuse
- Organic brain disorder
Sites / Locations
- Linköping University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
IPT
BRT
Arm Description
Interpersonal Psychotherapy for Major Depressive Disorder
Brief Relational Therapy adapted for treatment of Major Depressive Disorder
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale, 17 item version
The primary outcome is depression severity immediately after termination, controlling for depression severity immediately before treatment. Depression severity is measured using the 17 item version of the Hamilton Depression Rating Scale.
Secondary Outcome Measures
Patient Health Questionnaire - 9
Inventory of Interpersonal Problems
Quality of Life Inventory
Depressive Experiences Questionnaire
Outcome Questionnaire - 45
Full Information
NCT ID
NCT00763594
First Posted
September 30, 2008
Last Updated
August 31, 2021
Sponsor
Linkoeping University
Collaborators
Swedish Council for Working Life and Social Research
1. Study Identification
Unique Protocol Identification Number
NCT00763594
Brief Title
Linköping University Relational and Interpersonal Psychotherapy Project
Acronym
LURIPP
Official Title
Randomized Controlled Trial of Interpersonal and Brief Relational Psychotherapy for Major Depressive Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Too slow recruiting of patients/therapists to the study
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Swedish Council for Working Life and Social Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the relative efficacy of Interpersonal Psychotherapy and Brief Relational Therapy for Major Depressive Disorder. The primary hypothesis is that there will be no mean difference in efficacy between treatments, but that Brief Relational Therapy will be more efficacious for more self-critical patients and Interpersonal Psychotherapy will be more efficacious for less self-critical patients.
Detailed Description
Interventions Interpersonal Psychotherapy (IPT; Klerman et. al., 1984) is an evidence-based, time-limited treatment originally developed for treating Major Depressive Disorder, although it has been extended and developed for Bulimia Nervosa and recently also for Post-Traumatic Stress Disorder. The treatment is structured and focuses on relieving depressive symptoms by targeting interpersonal problems in the patients' current life situation. In the first four sessions an interpersonal problem area is identified that is asssumed to maintain the patient's depression and this problem is agreed upon as a therapy focus. Four types of focus areas are used in IPT: grief, role transitions, conflicts, and interpersonal deficits. In the middle phase of therapy the agreed upon focus area is worked with in a problem-solving fashion, and the patient is also encouraged to seek interpersonal support from his or her environment. IPT has been established as an evidence-based treatment for Major Depression (Roth & Fonagy, 2005), and a recent meta-analysis concluded that it was slightly superior to other established treatments for MDD including Cognitive Behavior Therapy (Cuijpers, van Straaten, Andersson & van Oppen, 2008).
Brief Relational Therapy (BRT; Safran & Muran, 2000) is a relatively new version of Short-Term Psychodynamic Psychotherapy, based on relational psychoanalytic theory in combination with research on processes of rupture and repair of the therapeutic alliance. The therapeutic alliance, operationalized as the positive bond between patient and therapist in combination with agreement on tasks and goals of treatment, is the single most robust predictor of good outcome in psychotherapy research (Lambert & Ogles, 2004). BRT was developed to help patients who had previously failed in psychotherapeutic treatment(s), presumably because of trouble in establishing a working therapeutic alliance with their therapist(s). Therapists are trained to be highly attentive to the therapeutic relationship and to signs of ruptures in the alliance, and to use self-disclosure and meta-communication about ruptures in order to repair the therapy alliance and at the same time help patients to develop a generalized capacity for observing self and others (mentalization). BRT has shown preliminary evidence for efficacy with patients who are at risk of negative outcome in psychotherapy (Safran, Muran, Samstag & Winston, 2005) and with patients diagnosed with DSM-IV axis II personality disorders (Muran, Safran, Samstag & Winston, 2005). A specific manual for BRT in Major Depressive Disorder is currently under development (Holmqvist, in preparation).
Both treatments consist of 16 therapy sessions which are all video-taped for adherence checks. The same therapists will provide both treatments, in randomized order.
Objectives The objectives of the study are to compare the new treatment BRT with the established treatment IPT in the alleviation of Major Depressive Disorder. The hypothesis of the trial is that BRT will be superior for patients who have more difficulty establishing a therapeutic alliance, while IPT will be superior for patients with less difficulty establishing a therapeutic alliance. Previous research indicates that baseline self-critical perfectionism negatively predicts outcome in IPT as well as several other brief psychotherapeutic treatments for depression, and that this is because self-critical perfectionism will cause problems in the therapeutic alliance (Luyten, Corveleyn & Blatt, 2005). The primary hypothesis is thus that baseline self-cricial perfectionism moderates the relationship between treatment and outcome. Secondary exploratory objectives are to conduct in depth process research on the mechanisms of change in these treatments, as well as interaction effects between treatment modality and other patient characteristics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depression, Interpersonal Psychotherapy, Brief Relational Therapy, Outcome research
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPT
Arm Type
Active Comparator
Arm Description
Interpersonal Psychotherapy for Major Depressive Disorder
Arm Title
BRT
Arm Type
Experimental
Arm Description
Brief Relational Therapy adapted for treatment of Major Depressive Disorder
Intervention Type
Behavioral
Intervention Name(s)
Brief Relational Therapy
Other Intervention Name(s)
Relational psychotherapy, Psychodynamic therapy, PDT
Intervention Description
16 weeks of psychodynamically informed and therapy alliance focussed psychotherapy adapted for treating Major Depressive Disorder.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
16 weeks of Interpersonal Psychotherapy for Major Depressive Disorder
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, 17 item version
Description
The primary outcome is depression severity immediately after termination, controlling for depression severity immediately before treatment. Depression severity is measured using the 17 item version of the Hamilton Depression Rating Scale.
Time Frame
Change from before treatment to after termination (16 weeks)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire - 9
Time Frame
Change from before treatment to after termination (16 weeks)
Title
Inventory of Interpersonal Problems
Time Frame
Change from before treatment to after termination (16 weeks)
Title
Quality of Life Inventory
Time Frame
Change from before treatment to after termination (16 weeks)
Title
Depressive Experiences Questionnaire
Time Frame
Change from before treatment to after termination (16 weeks)
Title
Outcome Questionnaire - 45
Time Frame
Change from before treatment to after termination (16 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Depressive Disorder (DSM-IV)
Hamilton Depression Rating Scale (17-item version) score 20 or greater
Exclusion Criteria:
Any psychotic disorder
Substance abuse
Organic brain disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Falkenström, MA
Organizational Affiliation
Sörmland County Council, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
SE-581 83
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Linköping University Relational and Interpersonal Psychotherapy Project
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