Major Depressive DisorderPhase 2LURIPPNCT00763594
Linköping University Relational and Interpersonal Psychotherapy Project
A Phase 2 study testing Brief Relational Therapy and Interpersonal Psychotherapy in people with Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brief Relational Therapy and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Major Depressive Disorder (DSM-IV)
- Hamilton Depression Rating Scale (17-item version) score 20 or greater
Who cannot join
- Any psychotic disorder
- Substance abuse
- Organic brain disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Interpersonal and Brief Relational Psychotherapy for Major Depressive Disorder.
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Brief Relational Therapy, Interpersonal Psychotherapy
- Keywords
- Major Depression, Interpersonal Psychotherapy, Brief Relational Therapy, Outcome research
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Relational TherapyBehavioural
Also called Relational psychotherapy, Psychodynamic therapy, PDT
16 weeks of psychodynamically informed and therapy alliance focussed psychotherapy adapted for treating Major Depressive Disorder.
Interpersonal PsychotherapyBehavioural
16 weeks of Interpersonal Psychotherapy for Major Depressive Disorder
| Study group | Role | What they receive |
|---|---|---|
| IPT | Active comparator | Interpersonal Psychotherapy for Major Depressive Disorder Receives: Behavioral: Brief Relational Therapy; Behavioral: Interpersonal Psychotherapy |
| BRT | Experimental | Brief Relational Therapy adapted for treatment of Major Depressive Disorder Receives: Behavioral: Brief Relational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from before treatment to after termination (16 weeks)
Secondary outcomes (5)
Patient Health Questionnaire - 9
Measured: Change from before treatment to after termination (16 weeks)
Inventory of Interpersonal Problems
Measured: Change from before treatment to after termination (16 weeks)
Quality of Life Inventory
Measured: Change from before treatment to after termination (16 weeks)
Depressive Experiences Questionnaire
Measured: Change from before treatment to after termination (16 weeks)
Outcome Questionnaire - 45
Measured: Change from before treatment to after termination (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2016
- Study completionDec 2017
Why it stopped: Too slow recruiting of patients/therapists to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Fredrik Falkenstrom, Linkoeping University
- Investigators
- Fredrik Falkenström, MA, Principal investigator, Sörmland County Council, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763594
- Sponsor's protocol ID
- M59-08
- Acronym
- LURIPP
- Status last verified
- Aug 2021
- First submitted
- 30 Sep 2008
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Interpersonal and Brief Relational Psychotherapy for Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT00763594
- Acronym / sponsor ID
- LURIPP / M59-08
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depression, Interpersonal Psychotherapy, Brief Relational Therapy, Outcome research
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruiting of patients/therapists to the study
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Sep 2008
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT | Active comparator | Behavioral: Brief Relational Therapy, Behavioral: Interpersonal PsychotherapyInterpersonal Psychotherapy for Major Depressive Disorder |
| BRT | Experimental | Behavioral: Brief Relational TherapyBrief Relational Therapy adapted for treatment of Major Depressive Disorder |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Major Depressive Disorder (DSM-IV)
- Hamilton Depression Rating Scale (17-item version) score 20 or greater
Key exclusion criteria (3 listed)
- Any psychotic disorder
- Substance abuse
- Organic brain disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Relational TherapyAlso: Relational psychotherapy, Psychodynamic therapy, PDT16 weeks of psychodynamically informed and therapy alliance focussed psychotherapy adapted for treating Major Depressive Disorder. | Behavioural | BRT, IPT |
| Interpersonal Psychotherapy16 weeks of Interpersonal Psychotherapy for Major Depressive Disorder | Behavioural | IPT |
Primary outcome
Hamilton Depression Rating Scale, 17 item version
Time frame: Change from before treatment to after termination (16 weeks)
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.
5 secondary outcomes
Patient Health Questionnaire - 9
Time frame: Change from before treatment to after termination (16 weeks)
Inventory of Interpersonal Problems
Time frame: Change from before treatment to after termination (16 weeks)
Quality of Life Inventory
Time frame: Change from before treatment to after termination (16 weeks)
Depressive Experiences Questionnaire
Time frame: Change from before treatment to after termination (16 weeks)
Outcome Questionnaire - 45
Time frame: Change from before treatment to after termination (16 weeks)
Results and safety
The study was stopped early (reason given: Too slow recruiting of patients/therapists to the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Falkenström, MA principal investigator
Sörmland County Council, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief Relational Therapy and Interpersonal Psychotherapy in people with Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too slow recruiting of patients/therapists to the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale, 17 item version (time frame: Change from before treatment to after termination (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.