RecruitingNAINTERVENTIONAL

A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients

This research is looking at two different types of talking therapy, called CBASP and BA, for adults who have persistent depression that hasn't improved with other treatments. These therapies are offered both as inpatient (staying at a hospital) and outpatient (attending appointments) programs. The main goal is to find out if the CBASP programme is more effective than the BA programme in reducing feelings of depression over a 16-week period. Researchers will also look at why certain treatments work better for some people than others. This is an important study because long-term depression can be very challenging to treat, and finding better ways to help people is a priority.

At a glance

Status

Recruiting

Phase

Sponsor

University of Greifswald

Enrolment target

396

Start

01 Dec 2021

Estimated completion

01 Apr 2028

Persistent Depressive Disorder Treatment-resistant Depression

What is this study about?

This study is looking into two types of talking therapy for adults who have long-term depression that's been difficult to treat. This kind of depression can be very tough because it lasts a long time and hasn't gotten better with usual treatments. Experts are trying to find new and more effective ways to help people in this situation.

The two therapies being compared are called CBASP (Cognitive Behavioral Analysis System of Psychotherapy) and BA (Behavioral Activation). CBASP was specifically designed for long-term depression. BA is a simpler form of another common therapy called CBT (Cognitive Behavioural Therapy), which has been shown to be helpful for depression. Both therapies will be offered with a mix of individual and group sessions, as well as nurse support and exercise, and will last for 16 weeks in total. This includes a period of staying at a hospital or day clinic, followed by group sessions once you're back home.

The main question the study wants to answer is whether the CBASP programme works better than the BA programme in reducing depression symptoms after 16 weeks. They also want to understand what might make one therapy more effective for certain people than for others. The goal is to provide better care for those with long-term, difficult-to-treat depression.

Key takeaways

The study compares two talking therapies (CBASP and BA) for long-term depression.
It's for adults whose depression hasn't responded to other treatments.
The program lasts 16 weeks, including inpatient/day clinic and outpatient phases.
Your current medications would be continued and managed by study doctors.
The main goal is to find out which therapy works best for this type of depression.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have been diagnosed with persistent depression that hasn't responded well to previous treatments. You would need to have fairly severe depression symptoms and a good understanding of German to take part.

There are certain reasons why someone might not be able to join the study. For example, if you have certain other mental health conditions like bipolar disorder or schizophrenia, or if you have an active problem with substance use. If you've recently had CBASP or BA therapy, or if you're unable to participate in the full in-person and outpatient therapy programmes, you wouldn't be able to join. Also, if you are currently in immediate danger of harming yourself, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with long-term depression?
Has your depression not improved with other treatments?
Are your depression symptoms fairly severe?
Do you have a good understanding of the German language?
Can you commit to attending all therapy sessions, including inpatient/day clinic and outpatient?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the CBASP or BA therapy. This programme lasts for a total of 16 weeks. It starts with about 10 weeks where you would either stay at a hospital or attend a day clinic. This initial period includes individual and group talking therapy sessions, support from nurses, and exercise therapy. After this, you would continue with 6 weeks of outpatient group therapy sessions.

Throughout the study, you would also continue to take any regular medication for your depression, which would be managed by the study doctors following standard guidelines. You would have regular check-ups and assessments to monitor your depression symptoms and how you are responding to treatment. The researchers will be studying your progress closely to understand how the therapies are working. The exact number of visits would be discussed with you, but it involves consistent attendance for the 16-week period.

Potential risks and benefits

Participating in this study might offer you access to specialised talking therapies that could help improve your depression symptoms. These therapies are designed for long-term, difficult-to-treat depression, and you would receive close monitoring and support. However, as with any treatment, there's no guarantee that it will work for everyone, and you might not feel better. Taking part in therapy can sometimes bring up difficult feelings, and the commitment to attending sessions could be demanding. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Charité, University Medicine Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Terminated
Universitätsklinikum Jena
Verified postcode
Jena, Germany· Recruiting
Universität zu Lübeck
Verified postcode
Lübeck, Germany· Recruiting
Universitätsklinikum Marburg
Verified postcode
Marburg, Germany· Recruiting
Klinikum der Universität München
Verified postcode
München, Germany· Recruiting
Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is 'persistent depression'?

It's a type of depression that lasts for a long time, often for years, and can be very difficult to treat with standard methods.

What is 'treatment-resistant' depression?

This means your depression hasn't gotten much better after trying at least a couple of different treatments, like medication or talking therapy.

Are CBASP and BA actual therapies?

Yes, they are both established types of talking therapy used to help people with depression.

Will I have to stay in hospital?

The study involves an initial period of about 10 weeks where you would either stay at a hospital (inpatient) or attend a day clinic, followed by outpatient group therapy.

Can I continue my regular medication?

Yes, you would continue your depression medication during the study; it will be managed according to medical guidelines.

How to find out more

Eva-Lotta Brakemeier, Prof. Dr.

eva-lotta.brakemeier@uni-greifswald.de +49 3834 420 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.