A new therapy that takes people outside of the therapist’s room is helping people with severe paranoia to lead more ordinary lives.
How can you understand whether a new treatment works? The usual answer is to conduct a randomised controlled clinical trial, where the outcome of delivering the new approach is compared to the current best approach.
This can tell you how effective the new approach fares in comparison to the current best approach, and you can infer something about how popular the treatment is by looking at how many people dropped out.
But to really understand why the treatment performed as it did and how people experienced it, numbers aren’t enough. You also need to speak to the people receiving the treatment.
This is what McPin did recently for an intervention called Feeling Safe. Feeling Safe is a new kind of therapy for people experiencing significant paranoia or persecutory delusions, developed by a team at the University of Oxford.
It is based on the idea that severe paranoia may be triggered by negative experiences which are then maintained by things like excessive worrying, low self-confidence, poor sleep and avoidance of feared situations.
Feeling Safe first tackles these ‘maintenance factors’, for example by helping people to sleep better and feel more confident, before supporting them to go back into everyday situations where they can (hopefully) learn to feel safe again.
The findings from the clinical trial were positive. People who were randomly assigned to receive Feeling Safe for 6 months showed significantly greater reductions in the strength of their paranoid beliefs and increases in their wellbeing than people randomly assigned to receive befriending therapy.
The result is thought to be the largest-sized effect of any treatment for people with persecutory delusions. What’s more, almost everyone completed all sessions of the therapy.
To find out what people who received Feeling Safe thought, McPin conducted an independent qualitative study, interviewing trial participants. Unsurprisingly our results were positive too.
The therapy was described by the people we interviewed as the therapist coming to their house to discuss their problems (the maintenance factors) before going out and about to build confidence in anxiety-provoking situations, first together and then alone.
After six months of sessions, people talked about being able to lead a more “ordinary” life. Of being able to walk the dog, go to cafes, volunteer and apply for jobs – things that other people take for granted.
They described reductions in anxiety and paranoia, their sleep and confidence improving, and being more able to cope with their voices.
Our results also shed light on which elements of the intervention people valued and why they thought it worked.
People resonated with the name of the therapy – they had felt unsafe – and they appreciated the elements of personalisation built into it (being able to choose the order of the maintenance modules and choosing where to go with the therapist).
They thought it “fitted” them well and they liked that it was a gradual process, allowing them to gain confidence slowly. People understood that to get the best out of the experience they needed to be open to it and take some responsibility for its success, even if this was challenging.
For example, one person spoke about the need to be honest about his fears with the therapist but also a reluctance to do so as he knew he would be asked to face them.
“More natural” therapy
The relationship with the therapist seemed central to the success of therapy, as essentially Feeling Safe requires people to take risks and face their fears. To do tasks and visit places that make them feel scared or uncomfortable.
Participants said they felt understood, cared about, and seen as individuals by the therapist. During the analysis process, we had discussions with the Patient Advisory Group about the trust required for participants to put themselves into these difficult situations.
One advisory group member remarked that having the therapist visit people’s homes and accompany them with everyday tasks may have contributed to a feeling of being known, and therefore able to trust what was asked of them.
Another person said that Feeling Safe seemed like a “more natural” form of therapy than one that is confined to a therapy room. Both these elements seemed important.
This is just a flavour of some of the results that came out of speaking to people who had received Feeling Safe. You can read more in our open access paper.
Of course, the real test of how well a therapy works is what happens in the real world, not under trial conditions. We don’t have that data yet as Feeling Safe is still being rolled out.
However, it was heartening to speak to a psychologist who had been trained to deliver Feeling Safe. “The beauty of Feeling Safe for the practitioner is that it gives you permission to take the therapy out of the room.
It’s a fundamental part of the treatment rather than something that is nice to do if you have time or only if it’s a sunny day. It really helps with people’s engagement”, says Marta Banet, who works for a housing association and the NHS.
“There are so few therapies to help people with persecutory delusions, it is amazing to have another option to offer the people we work with”.
Lived experience involvement in Feeling Safe
As with all of McPin’s work, expertise from experience was an integral part of the Feeling Safe project.
A Patient Advisory Group (PAG) made up of people with similar mental health experiences to the trial participants advised on the design of the trial and the qualitative study. The interviews were conducted by two researchers, one of whom was a member of the PAG, and the data were analysed by two researchers, one of whom had mental health experiences in common with the participants.
We held a meeting with the PAG during the analysis to discuss our initial interpretations, which both corroborated and helped to deepen them.
What did the McPin Patient Advisory Group (PAG) members think?
“I think the really good and important thing about the Feeling Safe CBT treatment is the fact that people would be given a choice right at the beginning about which modules they might want to work on.
The fact that they could pick the ones that could help them tackle their specific issues (worry, persecution, low esteem or tolerance etc) is very important.
One size fits all treatment is rarely helpful or useful. Feeling Safe would help people to feel that they were really involved from the start with the ‘treatment’ and really co-working with the therapist.
Also, the fact that there were a good number of regular meetings working with the psychologists over six months. These sessions could take place in the community where people would be able to work on their treatment in their everyday lives, in places where they felt comfortable.
They would not always have to receive treatment in a ‘mental health’ environment.
This sort of tailor- made treatment plan would have been so useful for me. I never found CBT useful as I was expected to do so much written work on my own which I never really felt was relevant to my life struggles! It was all about me somehow catching my negative thoughts before they influenced my behaviour which I couldn’t do.
I was being told: “You must do this treatment or you will never get better!” Not helpful as I felt like a failure all the time. Working with someone who was actually in my everyday life with things that would have specifically helped me with my difficulties would have been so helpful.
It was a really exciting experience working with the PAG for Feeling Safe research project! As a person who had suffered for many years with difficult life experiences, I thought the proposed Feeling Safe treatment sounded as if it could be so helpful for other people like me.
It looked as if it was going to be so geared to people’s individual needs and would involve working closely with a psychologist over a good period of time.
At the PAG meetings I always felt that we were respected and our opinions and thoughts were valued and taken notice of. I am really hopeful that my (our) input affected the design of the research in a small way and that I felt genuinely part of a “team” with the researchers.
I would like to thank Thomas from McPin for being there with us at the meetings and making them so feel so comfortable, rewarding and engaging.”
“I think it’s really important to have Feeling Safe as a treatment option as I believe psychological therapies to be an effective treatment, offering real long term solutions and coping strategies for people who experience mental health difficulties and psychosis.
This kind of therapy especially is invaluable as it offers choice within the therapy and is adapted to the needs of the individual.
It can be difficult to access psychological therapies within the NHS. I was only ever offered medications as a treatment despite requesting psychological therapy.
My only experience of CBT really prior to joining the PAG was using a workbook as a guide which was helpful but I don’t really think it is a substitute for working alongside a therapist.
I think it really important to have NHS alternatives to just being given pills to take which isn’t helpful for everyone. I personally did not find medication helpful long term and even felt, at times, it was detrimental to my wellbeing due to the side effects.
In terms of cost effectiveness from my own experiences, I personally do not rate medications as the long-term answer to mental ill health due to the negative impact they can often have on physical health and weight gain etc. which in turn can then impact on mental well-being leading to a downward spiral which can be difficult to break out from.
In the long run therefore I think psychological therapies potentially can offer much better outcomes and the prospect of a better quality of life for those who would like and receive this type of therapy.
Working within the PAG has been a really good experience. Being listened to and having input as a peer researcher valued by the principal investigators was a great experience.
Also being supported by the McPin foundation and receiving training to undertake the qualitative interviews really gave me the confidence to keep working towards a change of career.
I joined the PAG at a difficult time in my life as I had recently become unemployed due to experiencing mental health difficulties. I am now back to working full time doing a job that I really enjoy having transitioned into working within the NHS in mental healthcare.”