Condition category
Mental and Behavioural Disorders
Date applied
21/04/2009
Date assigned
10/07/2009
Last edited
24/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Manfred E Beutel

ORCID ID

Contact details

Clinic for Psychosomatic Medicine and Psychotherapy
University of Mainz
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany

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 measures

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

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

http://www.dgpt.de/

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

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22834725

Publication citations

  1. 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.

Additional files

Editorial Notes

24/03/2017: Recruitment dates were changed from 01/10/2007 - 01/10/2011 to 01/06/2007 - 12/07/2013. Overall trial end date was changed from 01/10/2011 to 24/02/2019. Added Plain English Summary and individual level data sharing plan.