Plain English Summary
Background and study aims
As chronic depression is often treatment-resistant and causes considerable disease burdens, it has been recognized as one of the major challenges for mental health care. Yet, there is a lack of good clinical trials both on psychotherapeutic and pharmacological treatments. The long-term outcome of cognitive-behavioral (a type of talking therapy) and psychoanalytic therapies (a type of therapy focusing on the emotional state, feelings and perceptions) of chronic depressed patients remains open to debate and there has been a paucity of high quality studies investigating long-term therapies. The study is the first comparing the long-term effectiveness of controlled cognitive-behavioral (CBT) and psychoanalytic therapies (PAT) of chronic depressed patients and to investigate the effects of preferential vs. randomized assessment.
Who can participate?
Adults aged 21 to 60 with major depression
What does the study involve?
In a partial randomization preference trial, patients are asked if they have a preference for one specific treatment (PAT or CBT). Treatments are outlined to them in terms of a general description. If they articulate a specific preference, they are assigned accordingly (preference arm). Assessment is conducted before assignment to treatments, and over a course of five years (including treatment). These include structured clinical interviews, questionnaires and health care utilization (self-report and health insurance data).
What are the possible benefits and risks of participating?
Participants may benefit from getting written information about the therapies before their decision to make a treatment choice. Participants may benefit from the improvement in their treatment however there is a risk that their mental health could get worse.
Where is the study run from?
Clinic for Psychosomatic Medicine and Psychotherapy (Germany)
When is the study starting and how long is it expected to run for?
October 2007 to February 2019
Who is funding the study?
1. German Society for Psychoanalysis, Psychotherapy, Psychosomatics and Depth Psychology (DGPT) (Germany)
2. Heidehof Stiftung GmbH (Germany)
Who is the main contact?
Professor Manfred E Beutel
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Psychoanalytic and cognitive-behavioural long-term treatment for chronic depression: short- and long-term effects of preferential treatment and randomised allocation
Acronym
LAC
Study hypothesis
1. Preferential treatment allocation will lead to better outcomes than randomised treatment allocation
2. Cognitive-behavioural treatment will achieve quicker effects than psychoanalytic treatment
3. Psychoanalytic treatment leads to more stable long-term effects
4. Reduction of health costs through the therapy
Ethics approval
Ethics Committee of Landesärztekammer Rheinlandpfalz approved on the 15th May 2007 (ref: 837.124.07[5659])
Study design
Randomised controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Can be found at: http://www.klinik.uni-mainz.de/fileadmin/kliniken/pt/Dokumente/Studien/0612_LAC_Patientenfolder_10_RZ.pdf
Condition
Chronic major depression in outpatient care
Intervention
Arm 1: Preferential treatment. The participants in this arm will choose either psychoanalytic treatment or cognitive-behavioural treatment.
Arm 2: Randomised allocation. The participants in this arm will be randomly allocated to either psychoanalytic treatment or cognitive-behavioural treatment.
Both treatments will last for a minimum of one year. This trial will take place in Berlin, Frankfurt, Hamburg and Mainz.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Depressive sympomatology, assessed with BDI 2 and QIDS-C at pre- and post-treatment. Treatment response is defined as at least 50% decrease in BDI 2 and QIDS-C scores.
2. Remission, defined as a QIDS-C score of less than 6
3. SKID
4. Operational psychodynamic diagnosis (Operationalisierte Psychodynamische Diagnostik) (OPD2)
All primary and secondary outcomes will be assessed at the initial examination (t0) and after 1, 2 and 3 years of treatment.
Secondary outcome measures
1. Symptom Checklist-90-R (SCL-90-R)
2. Social and Occupational Functioning Assessment Scale (SOFAS)
3. Depressive Experiences Questionnaire (DEQ)
4. Reduction in health costs, assessed using health insurance data
All primary and secondary outcomes will be assessed at the initial examination (t0) and after 1, 2 and 3 years of treatment.
Overall trial start date
01/10/2007
Overall trial end date
24/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, age range 21 - 60 years
2. Major depression (by SKID I, the German version of Structural Clinical Interview I [SCID I]) and/or dysthymia (by SKID I)
3. Complaints for at least 12 month
4. Quick Inventory of Depressive Symptomatology - clinician rating (QIDS-C) greater than 9
5. Beck Depression Inventory II (BDI II) greater than 17
6. Sufficent knowlege of the German language
7. No restriction of intellectual capacity
8. Consent to the study protocol, secrecy containment to the treating physician
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Current or in the case history psychotic symptomatology, schizoaffective, schizophrenic or bipolar affective disorder
2. Substance dependence current or during the last 3 years
3. Dementia
4. Borderline, schizotypal and antisocial personality disorder
5. Acute suicidality
6. Serious physical illness that strongly affects the depression or is causally for the depression
Recruitment start date
01/06/2007
Recruitment end date
12/07/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic for Psychosomatic Medicine and Psychotherapy
Mainz
D-55131
Germany
Sponsor information
Organisation
German Society for Psychoanalysis, Psychotherapy, Psychosomatics and Depth Psychology (DGPT) (Germany)
Sponsor details
Johannisbollwerk 20
Hamburg
20459
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German Society for Psychoanalysis, Psychotherapy, Psychosomatics and Depth Psychology (DGPT) (Germany) - main funder
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Heidehof Stiftung GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22834725
Publication citations
-
Protocol
Beutel ME, Leuzinger-Bohleber M, Rüger B, Bahrke U, Negele A, Haselbacher A, Fiedler G, Keller W, Hautzinger M, Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial., Trials, 2012, 13, 117, doi: 10.1186/1745-6215-13-117.