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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.

Sweden1 site
  • Linköping University

    Linköping, SE-581 83

Other trials in Sweden

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.

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 groups in NCT00763594
Study groupRoleWhat they receive
IPTActive comparatorInterpersonal Psychotherapy for Major Depressive Disorder
Receives: Behavioral: Brief Relational Therapy; Behavioral: Interpersonal Psychotherapy
BRTExperimentalBrief 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.

  1. 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)
  1. Patient Health Questionnaire - 9

    Measured: Change from before treatment to after termination (16 weeks)

  2. Inventory of Interpersonal Problems

    Measured: Change from before treatment to after termination (16 weeks)

  3. Quality of Life Inventory

    Measured: Change from before treatment to after termination (16 weeks)

  4. Depressive Experiences Questionnaire

    Measured: Change from before treatment to after termination (16 weeks)

  5. 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.

  1. First posted1 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2016
  4. Study completionDec 2017

Why it stopped: Too slow recruiting of patients/therapists to the study

Resources

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)
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

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.

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LURIPP Clinical Trial NCT00763594 | AzTrials