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Trial registered on ANZCTR


Registration number
ACTRN12612000909820
Ethics application status
Approved
Date submitted
24/08/2012
Date registered
27/08/2012
Date last updated
30/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression.
Scientific title
Efficacy of an adjunctive brief psychodynamic psychotherapy compared to treatment-as-usual for psychiatric inpatients with unipolar major depressive episode.
Secondary ID [1] 281089 0
Research supported by the Swiss National Science Foundation (SNSF), Grant No 32003B-135098
Universal Trial Number (UTN)
U1111-1133-8504
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar major depressive episode 287242 0
Condition category
Condition code
Mental Health 287567 287567 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inpatient brief psychodynamic therapy
Our manualized intervention model proposes a brief psychodynamic intervention program in 12 sessions over 4 weeks (Ambresin G, de Coulon N, Despland JN: Traitement psychodynamique bref de la depression pour patient hospitalise, Unpublished manuscript, Institute for Psychotherapy, Centre Hospitalier Universitaire Vaudois and University of Lausanne; 2008). Sessions are 45 minutes long (3 sessions per week). It is based on the Bush, Rudden & Shapiro (2004) manual of psychodynamic treatment of depression to help the therapy focalize on relevant depression foci. For transference, personality organization and conflictual themes the intervention is based on Despland, Michel, & de Roten (2010) manual on brief psychodynamic psychotherapy. Both manuals were adapted to the brief inpatient setting. Put briefly, the 12-session psychotherapy approaches the crisis in the patient’s intrapsychic and interpersonal equilibrium that led to a hospital admission, within the context of depression. It focuses on both the patient’s conscious and unconscious motives for admission. The initial hypothesis is based on the dynamic relationship established between the therapist and the patient during the first three sessions (pre-transference), on the patient’s present crisis, and on the dynamics that form the core of his/her depressive episode. Following sessions focalize further on helping the patient to gain a better understanding of the psychological factors that led to the emergence of depressive symptoms and to address his/her vulnerability to those dynamics. Final sessions address the patient’s feelings and fantasies about termination as well as the decision regarding a therapy of longer duration or long-term psychiatric treatment if necessary.
Intervention code [1] 285540 0
Treatment: Other
Comparator / control treatment
Treatment-as-usual
A manual (Preisig M, Lustenberger Y, Fassassi Gallo S, Ambresin G, Viani I, Saraga M, Quement B: Manuel du traitement psychiatrique integre (Treatment-as-usual) du patient deprime hospitalise, Unpublished manuscript, Institute for Psychotherapy, Centre Hospitalier Universitaire Vaudois and University of Lausanne; 2007) which follows the Practice guideline for the treatment of patients with Major Depression of the American Psychiatric Association (APA: Practice guideline for the treatment of patients with major depressive disorder, 3rd edn. Arlington (VA): American Psychiatric Association; 2010), contains all the treatments and procedures offered to patients. Treatment includes: (1) A first interview of 45 minutes to define a treatment plan made up of patient’s, nurses’, medical, and social objectives. Therapeutic staff meets once a week to adapt it; (2) Supportive interventions of 20 to 25 minutes (clinical management), addressing psychopharmacological issues when necessary, delivered twice a week by a psychiatric resident; (3) Weekly two 30-minute encounters with nurses aiming at developing the patient’s psycho-educational skills, empowerment, and individualized treatment; (4) 6 psychoeducation group sessions; (5) Social workers, ergo-, physio-, and art-therapist interventions integrated into the treatment as required by the patient’s needs; (6) Pharmacotherapy following the rules of the World Federation of Societies of Biological Psychiatry (Bauer, 2002).
Control group
Active

Outcomes
Primary outcome [1] 287820 0
Depressive symptoms as assessed by the Montgomery-Asberg Depression Scale (MADRS), a clinician rating measure in 10 items.
Timepoint [1] 287820 0
At study entry, weekly during inpatient stay and at 3 and 12 months after enrolment in the study.
Primary outcome [2] 287843 0
Depressive symptoms as assessed by the self-rated version of the Inventory of Depressive Symptom (QIDS-SR16), a 16-item self-report measure of depressive symptoms.
Timepoint [2] 287843 0
At study entry, weekly during inpatient stay and at 3 and 12 months after enrolment in the study.
Secondary outcome [1] 298889 0
Psychodynamic functioning as assessed by Heidelberg Structural Change Scale (HSCS) and Defense Mechanism Rating Scales (DMRS).
Timepoint [1] 298889 0
At beginning and end of the intervention
Secondary outcome [2] 298890 0
Therapeutic alliance with therapist and treatment team as assessed by Working Alliance Inventory Short-Form (WAI-SF) and Inpatient Treatment Alliance Scale (I-TAS)
Timepoint [2] 298890 0
At each session for the alliance with therapist and weekly for the alliance with treatment team.
Secondary outcome [3] 298891 0
Cost-effectiveness based on data collected on inpatient and outpatient files (hospitalizations, emergency department visits, outpatient psychiatrist, psychotherapist, physician, and other health care providers, and psychotropic and nonpsychotropic prescriptions) and indirect costs (productivity loss) and cost utility as assessed by European Quality of Life-5 dimensions (EQ-5D).
Timepoint [3] 298891 0
At baseline, discharge, 3- and 12-month follow-up.

Eligibility
Key inclusion criteria
All patients admitted in the university psychiatric hospital section specialized for the treatment of mood, anxiety and personality disorders are eligible to participate in the study if they meet the following inclusion criteria:
(1) Age 18-65 years old;
(2) unipolar major depressive episode;
(3) Montgomery-Asberg Depression Rating Scale > 18;
(4) sufficient mastery of the French language.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Any organic medical disorder, or persistent substance use/dependence which might affect brain function (memory, level of consciousness, cognitive abilities) thereby impairing the individual from participating and benefiting from psychotherapy;
(2) A psychotic disorder which makes a pronounced break in reality testing chronically or intermittently likely, such as schizophrenia, delusional disorder, or bipolar manic-depression (Type I);
(3) Any of the following which are considered unlikely to benefit from either treatment: axis II paranoid, schizoid or schizotypal, and borderline personality disorder; antisocial personality; recent suicide attempts with acute risk for suicide; other principal axis I disorder; severe cognitive impairment; previous absence of response to the study treatments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients hospitalized in the clinical unit with a diagnosis of major unipolar depression will be referred to the project, interviewed for eligibility by a research assistant (RA) and then given the intake assessment battery. Patients giving informed consent (to be randomly assigned to one of the treatment settings; to participate in the diagnostic and psychometric procedure; to agree, if necessary, that psychotherapy sessions are audio recorded; and to take part in the follow-up measurements) will then be randomized in one of the two treatment groups.
To guarantee allocation concealment, randomization will be done by a totally independent researcher, and each allocation will be given to the recruiting RA in a sealed envelope prior to seeing a new patient. The envelope will be opened if and only if the patient is included in the protocol. Assessors are blinded to treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatment groups will be done using a stratified block randomization method with permuted block (available at www.randomization.com). Three stratification variables will be used to ensure treatment balance: age (two levels: younger or equal to 40; older than 40), gender (two levels: M/F), and chronicity - that full criteria for a Major Depressive Episode have been continuously met for at least 2 years (two levels: Y/N).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 4507 0
Switzerland
State/province [1] 4507 0
Vaud

Funding & Sponsors
Funding source category [1] 285873 0
Government body
Name [1] 285873 0
Swiss National Science Foundation (SNSF)
Country [1] 285873 0
Switzerland
Primary sponsor type
Hospital
Name
Centre for Psychotherapy Research
Address
University Institute of Psychotherapy
Department of Psychiatry-CHUV
Av. de Morges 10
CH-1004 Lausanne
Country
Switzerland
Secondary sponsor category [1] 284698 0
Hospital
Name [1] 284698 0
Centre for Psychiatry Epidemiology and Psychopathology
Address [1] 284698 0
Department of Psychiatry-CHUV
Hopital de Cery
CH-1008 Prilly
Country [1] 284698 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287900 0
Ethics Committee of the University of Lausanne
Ethics committee address [1] 287900 0
Commission cantonale d'Ethique de la recherche sur l'etre humain
Case postale 15
1011 Lausanne
Ethics committee country [1] 287900 0
Switzerland
Date submitted for ethics approval [1] 287900 0
Approval date [1] 287900 0
Ethics approval number [1] 287900 0

Summary
Brief summary
Background: A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression.
Methods/Design: The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 140 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher.
Discussion: Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34615 0
Address 34615 0
Country 34615 0
Phone 34615 0
Fax 34615 0
Email 34615 0
Contact person for public queries
Name 17862 0
Gilles Ambresin
Address 17862 0
General Practice and Primary Health Care Academic Centre
The University of Melbourne
200 Berkeley Street
Carlton, VIC 3053
Country 17862 0
Australia
Phone 17862 0
+61 3 8344 9010
Fax 17862 0
Email 17862 0
[email protected]
Contact person for scientific queries
Name 8790 0
Yves de Roten
Address 8790 0
Centre for Psychotherapy Research
University Institute of Psychotherapy
Department of Psychiatry-CHUV
Av. de Morges 10
CH-1004 Lausanne
Country 8790 0
Switzerland
Phone 8790 0
+41 21 314 05 86
Fax 8790 0
Email 8790 0
[email protected]

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