If chronic depressive patients choose their treatment... Psychoanalytic and cognitive-behavioural long-term treatment for chronic depression
| ISRCTN | ISRCTN91956346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91956346 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/04/2009
- Registration date
- 10/07/2009
- Last edited
- 12/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Clinic for Psychosomatic Medicine and Psychotherapy
University of Mainz
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany
Study information
| Study design | Randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.klinik.uni-mainz.de/fileadmin/kliniken/pt/Dokumente/Studien/0612_LAC_Patientenfolder_10_RZ.pdf |
| Scientific title | Psychoanalytic and cognitive-behavioural long-term treatment for chronic depression: short- and long-term effects of preferential treatment and randomised allocation |
| Study acronym | LAC |
| Study objectives | 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(s) | Ethics Committee of Landesärztekammer Rheinlandpfalz approved on the 15th May 2007 (ref: 837.124.07[5659]) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2007 |
| Completion date | 24/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 252 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 12/07/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
D-55131
Germany
Sponsor information
Research organisation
Johannisbollwerk 20
Hamburg
20459
Germany
| Website | http://www.dgpt.de/ |
|---|---|
"ROR" |
https://ror.org/01hd27x96 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/07/2012 | Yes | No | |
| Results article | results | 01/01/2019 | 14/02/2020 | Yes | No |
| Results article | 09/08/2024 | 12/08/2024 | Yes | No |
Editorial Notes
12/08/2024: Publication reference added.
14/02/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
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.
