Using Tech-Based Interventions to Improve Relapse and Quality of Life in Bipolar Disorder

Evan H. Goulding, MD, PhD, department of psychiatry and behavioral sciences, Northwestern University, Chicago, Illinois, discusses the results of his latest study "Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life," recently published in JAMA Psychiatry. Dr Goulding and co-authors believe this study's results are step in the right direction for integrating more technology-based solutions into patient care and improve patient outcomes and quality of life. 

Evan Goulding, MD, PhD, is an Assistant Professor in the Department of Psychiatry and Behavioral Sciences at Northwestern University. His group’s research focuses on developing and testing smartphone based interventions for bipolar disorder with the goal of improving access to evidence-based psychosocial treatment.  In addition, by tracking self-report, application utilization and behavioral data, this research seeks to elucidate endophenotypes and trajectories in bipolar disorder to aid in providing more personalized and timely intervention. Overall, the goal of this research is to improve access to and understanding of bipolar disorder treatment so that the right treatment strategy can be delivered at the right time to the right person and thereby help individuals with bipolar disorder to live well.

Read the Transcript: 

I'm Evan Goulding. I'm an Assistant Professor of Psychiatry at Northwestern University and I work on developing smartphone-based interventions for individuals with bipolar disorder to help them with self-management.

Psych Congress Network: What led you and your colleagues to investigate this smartphone-based care for patients with bipolar disorder?

Dr Goulding: So, the primary treatment for bipolar disorder is pharmacotherapy, but there's decent data from a number of face-to-face randomized controlled trials to demonstrate that adjunctive psychotherapy helps people decrease relapse risk, kind of decrease symptoms, symptom burden somewhat between episodes and overall, and then can improve quality of life. And they usually work through helping people take their medications. The idea is that they help people take their medications, which is important, so support medication adherence. Support people in getting the right amount of sleep, keeping a regular routine, and then doing what's called early warning sign management. So in other words, kind of identifying what early signs of depression and mania are for them, making a plan for how to handle those, and then kind of managing those. Those are the four we focused on. There's other things like support, communication skills, problem solving skills, interpersonal skills that are also important, but the ones we focused on are more behavioral.

The deal is that even though we know these therapies work and there's treatment guidelines that recommend providing therapy to people with bipolar disorder, only about half of people with bipolar disorder receive any psychotherapy at all. So, that raises the question of can you kind of take some of these self-management techniques derived from empirically based psychotherapies and increase access to them using a smartphone? And then the smartphone has other advantages. It can operate in real time. You can get people's self-report data and provide adaptive feedback, both to the person using the app, but also maybe alerts to their provider to help intervene early if things aren't going well. And then we haven't done this yet, but we collected data on how they use the app. We got self-report data kind of daily on how they're rating their mood, their medication adherence, routine, sleep, and then weekly kind of self-assessments for mania depression, as long as sensor data like activity levels, location, how many texts they're sending, when people are making calls, how long they are. Some people allowed us to look at the content of their text data.

So, all of those things over time may help us to actually improve the intervention, both by providing adaptive feedback but also getting a better idea of kind of, are there different, can we stratify people? Are people at different levels of risk? So those are all kind of important features. I think increasing access was our primary goal, but also maybe gaining a better understanding of this population and providing them with the right treatment at the right time is another important long-term goal. And then the other piece is there's a lot of publicly available smartphone apps for bipolar disorder, but there's really none out there that are publicly available to my knowledge that have an evidence base, and there haven't been prior trials. There's a number of trials working on smartphone apps that kind of demonstrate that people are interested in using them and they have some benefits, but overall we haven't fully figured out how to make it work. And then most of the smartphone interventions for bipolar haven't looked at long-term outcomes. We looked at relapse over 48 weeks, which is one of kind of the primary outcomes the face-to-face trials looked at. So, that was the main thing is increase access and try to improve treatment by getting additional data and delivering real-time feedback.

PCN: Please briefly describe the study method and your most significant findings. Were there any outcomes different than you expected? 

Dr Goulding: So the study consists of really three parts. There's the app that people use and then there's a coach that supports people in using the app kind of just to report their adherence, deal with technical issues, but also serve as kind of a concierge for the self-management strategies to kind of... There's an expert system that provides feedback both to the participant but also to the coach to kind of say, "Oh, this person isn't taking their medication," or they're having problems with sleep or they have some early warning signs so that the coach can kind of follow a flow sheet. They're mostly, the coaches we had were people we hired, you know, finished college and interested in medicine who then don't have training as clinicians so we kind of supervised them, but they're not clinicians. And then the other piece that was important that maybe didn't work as well as we'd like was they also served to kind of communicate, facilitate communication with the care providers.

And then the app itself really consists of some lessons and then a toolbox that has self-assessment and skills, and then the coach meets once face-to-face with people and that really focuses on helping them develop this wellness scale that goes... It's nine points, and kind of identifying what are you like when you're balanced, when you have normal ups and downs, what early warning signs look like for you, what does a mood episode look like, what does a crisis look like. We had to get them to anchor that because they're going to use that on a daily basis and that's kind of a core of the application is a daily check-in where people say, did you take your medication? Some, none or all. How much sleep did you get? They set a goal for how much sleep they get. We try to get everybody to commit to take their medications all the time, and this is just their bipolar medications. And then keep a regular routine, which for us, we just have a set like a bedtime and rise time, like a window, and then rate that wellness rating scale.

And then at 4 weeks after they kind of read the lessons, they make plans for managing their wellness levels. So, each level there's a plan, and then also just like sleep medication, attended diet, exercise and substance use. Keeping a regular routine. We call it smart, so tranquil is managing stressors, and then the last one is support. But the main kind of targets of the intervention are medication adherence, get the right amount of sleep, keep a regular routine, and then do this what's called early warning sign management. And then there's a website and server that kind of serves to communicate between send alerts to providers and the coach and then the coach can also make phone calls.

So, that's kind of the intervention. Really, the active part of the intervention is over 16 weeks. You develop this wellness plan over the first four weeks. The coach checks in on how that's going and make adjustments at six weeks, and then at 16 weeks we do a wrap up call where we're kind of like... We're not going to ask you to check in every day and every week anymore, but what did you get out of this? What will you do next? When would you return to using this? And so then we ask them to carry it for a year so that we can get that behavioral data for a year and kind of help us understand how things are going and maybe predict what's going on.

And so then from that, that was a pretty long development process that led up to this randomized control trial. So, we enrolled 205 people. We put more people in the intervention arm because we're interested in understanding how the intervention works, so it was 124 under the intervention arm, 81 in the control arm. And then of the people who showed up to start the intervention, really, we analyze everybody, but like 117 people showed up to get the app and get trained. 70% of them offered to ask us to try to get their provider enrolled, and that was an important piece. I mean, self-management shouldn't be misinterpreted as just doing everything yourself. Part of self-management is knowing when to reach out for support and work with your mental health providers, so we really wanted to enroll providers, but we only got about 27% of the providers to enroll. I think about 40% declined and another 30% didn't get back to us. So, that was a little disappointing because that's an important part of the intervention in our mind.

And then the primary outcome was time to relapse, and then we looked at depressive symptoms, manic symptoms, quality of life, and then percent time symptomatic. One of the things we did that we thought was important is because some of these interventions really focus on people who are in what's called asymptomatic recovery, so they don't have any... They've had at least 8 weeks with 2 or fewer moderate symptoms. You need a moderate symptom to kind of qualify for a mood episode. There's like certain criteria for depression and mania. And then asymptomatic recovery means you have no moderate symptoms after at least eight weeks with 2 or fewer moderate symptoms. So, that was about 44% of our population. 56% were in a high risk group. The high risk group is mostly people in recovery. About two-thirds of that group are recovering. So, they haven't had eight weeks with two or fewer moderate symptoms yet.

So most of them are probably pretty close to an episode, of having had one, but some of them actually are what's called continued symptomatic so they have a lot of symptoms but they don't quite qualify for an episode. And then some of them are in symptomatic recovery so they've had eight weeks with two or fewer moderate symptoms, but now they still have some moderate symptoms. And then it's like a small percentage of the people, about 7%, who were in the high risk group were recovering, were prodromal, so they've recovered but now they have new symptoms. Also, all of those things put you at higher risk for relapse. So, that's the structure of the study, and our primary outcome, we were disappointed. We didn't overall decrease relapse risk. It was about 43% in the control arm at 48 weeks versus 30% in the intervention arm.

But because we stratified ahead of time, we were able to look at, is there a difference between the low and high risk group? And that was actually quite striking that in the low risk group, about 30%, 37% of the control arm relapsed by 48 weeks, but only 12% of the intervention arm, compared to the high risk group which was 48% in the control and 44% in the intervention arm, so there's a big difference. Then there were some small decreases in manic symptoms, severity only in the high risk group. Depressive symptom severity for both, and then social relational kind of quality of life decreased, improved a little bit in both groups. So, that was the structure of the study and what we tried to do.

PCN: What practical applications of your findings are there for clinicians treating patients with bipolar disorder, particularly clinicians using digital therapeutics? 

Dr Goulding: I mean, there were some reasons to suspect that this might work better for people in asymptomatic recovery because some of the original interventions are really focused on that, but a lot of the studies in the past have included people who aren't in asymptomatic recovery, and we did that too because we're trying to reach a broad population. But I would say the main thing is you really do want to kind of, when you're meeting people and assessing them, determine whether or not they're in asymptomatic recovery and if they are helping them to maintain medication adherence or establish that if they're not. You know, get the right amount of sleep, keeping a regular routine. And then probably one of the most important things, we haven't finished, but initial kind of mediation analysis suggests that the early warning sign management and quality of sleep are probably important for the impact in the low risk group on decreasing relapse.

And so for that group, this just provides further support that working on those are helpful and that maybe an app like this can really help people to do it more independently because the monitoring is kind of a core piece of the app. And then for people who aren't in asymptomatic recovery, it's pretty clear that we need to kind of see them frequently and be aggressive in treatment to try to get them into asymptomatic recovery if we can or provide some kind of different treatment than what we were doing to help them do better, whether it's improved quality of life or actually decrease those symptoms and relapse risk. I would say that's the main take home message is that these apps can help people, but they're probably not the right thing for everybody.

PCN: What related or continuing studies do you feel are needed? Do you plan to have any involvement in that further research?

Dr Goulding: We're hoping to kind of continue to develop the app, and it probably needs to at some level be kind of commercialized. We started this kind of early on in the app development phase, so there's ways to make it kind of fancier in terms of just what people are working with, but also like how do we engage providers, because we didn't do as well as that as we'd hope, so we're going to investigate how do we engage providers. We're still looking at, how does people self-report data line up with our kind of more standard assessments? Does the behavioral data help us kind of predict how people are doing? That kind of comes back to the idea of engaging providers because the whole idea of that is to kind of be able to provide feedback both to the participant, the person who's using the phone with bipolar disorder, but also to help engage their providers.

And then we want to kind of do what we did when we developed this, which is go back to people who have bipolar disorder in that high risk group and say, "Well, here's some ideas about things we think might be more helpful than what we did before. What do you think about those? Would you be willing to use them? Are they important to you?" And so kind of things like people had said, the support, which we didn't really monitor, is important to them. And then other things are getting people to practice skills, which wasn't something we focused on, might be helpful for that group, whether they be about problem solving, meditation. You know, what can we do to help that group get into communicate better with their providers? So, those are some of the future directions, I'd say. Engaging providers, figuring out how to help the higher risk group. What do they need? Can we provide some of it via the smartphone? And then we probably need to replicate the result for the individuals in asymptomatic recovery, and we might, if you think about kind of a step care model, it might be nice to try to look at, what can you do to make the app so that we don't need the coach or you kind of reduce the coaching?

But I'm not sure how... The majority of the data for these apps is having somebody like a care manager or a coach is important. But perhaps there's a group of people. This group of people who came to our study are probably pretty motivated. We haven't published it yet, but their medication adherence is very high, right? And that is different than the general population of people. So, these are people who are seeing a psychiatrist, many of them have a therapist, they're committed to taking their medication, so they don't have issues with not thinking they have bipolar disorder, which can be a barrier for some people.

So that's a whole other area that, how do you begin to help those people? But that probably isn't the population that we saw in our studies. I think continuing to understand, like people with bipolar disorder are not some homogeneous group of people. There's lots of variability, and how do we help understand what will help who and deliver to them at the right time. That's kind of the idea of these smartphone based apps is that they are adaptive and they have real time feedback, and that over time maybe we can get a better sense of who needs what and when.