The explosion of mental health apps raises substantial opportunities–and also difficult questions

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In the eyes of the tech indus­try, men­tal health treat­ment is an area ripe for disruption.

In any giv­en year, 1 in 5 adults in the U.S. expe­ri­ence a form of men­tal ill­ness, accord­ing to fed­er­al esti­mates. And research indi­cates only about half of them receive treat­ment in a sys­tem that is under­staffed and ill dis­trib­uted to meet demand.

For tech star­tups look­ing to cash in on unmet need, that trans­lates into more than 50 mil­lion poten­tial customers.

Ven­ture cap­i­tal firms invest­ed more than $2.4 bil­lion in dig­i­tal behav­ioral health apps in 2020 — more than twice the amount invest­ed in 2019 — tout­ing sup­port or treat­ment for issues from burnout and depres­sion to ADHD and bipo­lar dis­or­der. At least sev­en men­tal health app com­pa­nies have achieved “uni­corn” sta­tus and are val­ued at more than $1 billion.

But even as indus­try hype mounts, researchers and com­pa­nies are scram­bling to prove these apps actu­al­ly work. Of the esti­mat­ed 20,000 men­tal health apps avail­able for down­load on per­son­al com­put­ers and smart­phones, just five have been for­mal­ly vet­ted and approved by the Food and Drug Admin­is­tra­tion, which large­ly has tak­en a hands-off approach to reg­u­lat­ing the space.

“Devel­op­ment has real­ly out­paced the sci­ence,” said Stephen Schueller, a clin­i­cal psy­chol­o­gist at the Uni­ver­si­ty of Cal­i­for­nia-Irvine who spe­cial­izes in the devel­op­ment and eval­u­a­tion of dig­i­tal men­tal health products.

Type “depres­sion” or “anx­i­ety” into an app store, and you’ll be met with a dizzy­ing list of results. There are thou­sands of “well­ness” apps like Head­space that coun­sel peo­ple on breath­ing exer­cis­es and oth­er tech­niques to help them feel more mind­ful. Apps such as Woe­bot and Talk­Life pro­fess to help man­age con­di­tions like anx­i­ety and post­par­tum depres­sion using games, mood jour­nal­ing or text exchanges with peers or auto­mat­ed bots.

Some apps are meant to be used along­side in-per­son ther­a­py, and oth­ers on their own. Sev­er­al of the most pop­u­lar, like Talk­space, Bet­ter­Help and Gin­ger, promise access to treat­ment with a licensed ther­a­pist over text mes­sage, phone or video. Oth­ers, includ­ing Bright­side and Cere­bral, con­nect users to psy­chi­a­trists who can pre­scribe antidepressants.

Most prod­ucts make their mon­ey by charg­ing con­sumers a month­ly or annu­al fee, with the option to pur­chase extras like video ses­sions with a ther­a­pist. Oth­ers con­tract direct­ly with employ­ers or insurers.

And, yes, a small por­tion of these apps have promis­ing research to back them up. Sev­er­al stud­ies, for exam­ple, have found that cog­ni­tive behav­ioral ther­a­py, a main­stay of treat­ment for depres­sion and anx­i­ety that seeks to help patients change neg­a­tive thought pat­terns, is as effec­tive when deliv­ered using web-based plat­forms as when done in per­son by a licensed pro­fes­sion­al. And the pan­dem­ic has bol­stered claims that patients are will­ing to trade in-per­son vis­its for the ease of online connection.

“Dig­i­tal men­tal health can be viewed as a way to extend the men­tal resources that we have,” said David Mohr, who directs the Cen­ter for Behav­ioral Inter­ven­tion Tech­nolo­gies at the North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine. A step-care mod­el, for exam­ple, would allow patients with milder symp­toms to be treat­ed via tech­nol­o­gy while reserv­ing in-per­son care for patients who need some­thing more.

The chal­lenge for con­sumers is sep­a­rat­ing the apps that might help from those that offer lit­tle more than dis­trac­tion — or could actu­al­ly do harm.

Some com­pa­nies offer­ing men­tal health treat­ment had recent­ly been doing some­thing total­ly dif­fer­ent — for exam­ple, an online sell­er of erec­tile dys­func­tion and hair loss treat­ments has start­ed offer­ing psy­chi­atric eval­u­a­tions and pre­scrib­ing and sell­ing antidepressants.

Tech com­pa­nies are by nature for-prof­it and, in the rush to com­pete in a sat­u­rat­ed mar­ket, many are sell­ing a prod­uct with an appeal­ing user inter­face but lit­tle evi­dence of effec­tive­ness. A 2020 analy­sis by Aus­tralian researchers review­ing near­ly 300 apps for anx­i­ety and depres­sion found just 6% of the com­pa­nies that boast­ed an evi­dence-based frame­work in the app store descrip­tion for their prod­ucts had pub­lished any evidence.

Nor do star rat­ings and down­load totals offer much con­text: An April study from Beth Israel Dea­coness Med­ical Cen­ter and Har­vard Med­ical School found lit­tle cor­re­la­tion between app store met­rics and treat­ment quality.

“No one is com­pet­ing based on pri­va­cy, safe­ty or evi­dence. They’re com­pet­ing on aes­thet­ics, in part, on page rank­ing, mar­ket­ing on brand aware­ness,” said Dr. John Torous, direc­tor of the dig­i­tal psy­chi­a­try divi­sion at Beth Israel Dea­coness Med­ical Cen­ter and one of the authors of the April study. “There’s an implic­it assump­tion that the app is bet­ter than noth­ing. But what if it isn’t bet­ter than nothing?”

One prob­lem, said Dr. Ipsit Vahia, a geri­atric psy­chi­a­trist and med­ical direc­tor of the McLean Insti­tute for Tech­nol­o­gy in Psy­chi­a­try, is that ran­dom­ized con­trol stud­ies of the kind that might prove an app’s effec­tive­ness can take years, far slow­er than the rapid inno­va­tion in tech. “In gen­er­al, the health care indus­try and the tech­nol­o­gy indus­try work at very dif­fer­ent paces,” Vahia said.

Dr. David Mou, a psy­chi­a­trist at Mass­a­chu­setts Gen­er­al Hos­pi­tal who is chief med­ical offi­cer at Cere­bral, said he agrees that every­thing new in health care must be done delib­er­ate­ly and con­ser­v­a­tive­ly to avoid patient harm. But he said some peo­ple in the men­tal health field are paint­ing all com­pa­nies with the same brush and fail­ing to dif­fer­en­ti­ate those that are data-dri­ven from those try­ing to grow at any cost.

“They look at us and say we’re all VC-backed bros in a base­ment try­ing to redesign health care. And that’s not true. It may have been true 10 years ago, but it isn’t true today,” said Mou. The long-term win­ners, he said, will be those that are “evi­dence-based and mea­sure qual­i­ty like crazy.”

Cere­bral offers online ther­a­py and med­ica­tion man­age­ment and deliv­ery for a range of men­tal ill­ness­es. The month­ly sub­scrip­tion fees range from $29 to $325, depend­ing on the lev­el and fre­quen­cy of care, as well as insur­ance cov­er­age. Mou said Cere­bral is already able to demon­strate some advan­tages. While many top hos­pi­tal sys­tems might have a months-long wait for care, he said, some­one in cri­sis can reach a Cere­bral provider almost imme­di­ate­ly. “With­in min­utes you are able to talk with some­one with one of our instant live vis­its. That in itself is a huge win.”

Even crit­ics of the tech explo­sion are quick to acknowl­edge that the cur­rent brick-and-mor­tar sys­tem of men­tal health is dat­ed and inad­e­quate. In recent years, the issues sur­round­ing men­tal ill­ness and lack of access to treat­ment have infil­trat­ed pub­lic dia­logue. Brain ill­ness­es that many fam­i­lies once squir­reled away from view have become the stuff of celebri­ty cul­ture and din­ner-table chatter.

Yet even as advo­cates have made strides in accep­tance, tru­ly improv­ing the lives of peo­ple with men­tal ill­ness has proven stub­born­ly dif­fi­cult. Over the past sev­er­al decades — while the U.S. suc­cess­ful­ly low­ered death rates for can­cer, heart dis­ease and oth­er major ill­ness­es — deaths by sui­cide and drug over­dose have con­tin­ued to climb.

Fed­er­al law the­o­ret­i­cal­ly requires insur­ance com­pa­nies to cov­er brain ill­ness as they would any oth­er ill­ness. But find­ing afford­able care remains a chal­lenge, large­ly because of a short­age of licensed men­tal health pro­fes­sion­als and ongo­ing inequities in insur­ance coverage.

In a nation where huge swaths of the pop­u­la­tion lack a pri­ma­ry care doc­tor and health insur­ance — but most every­one has a cell­phone — con­nect­ing peo­ple to treat­ment via mobile apps would seem a log­i­cal solu­tion. And, for some, the oppor­tu­ni­ty to talk about their men­tal health chal­lenges anony­mous­ly makes online treat­ment an attrac­tive alternative.

Still, many of the experts who wel­come the poten­tial for inno­va­tion in men­tal health treat­ment acknowl­edge that con­sumers are get­ting lit­tle guid­ance in how to choose a rep­utable option. “Well­ness” apps that pro­mote a healthy lifestyle or apps that help peo­ple man­age their dis­ease with­out pro­vid­ing spe­cif­ic treat­ment sug­ges­tions can avoid FDA reg­u­la­tion. But even those that offer patient-spe­cif­ic diag­noses and treat­ment rec­om­men­da­tions that would seem to fall square­ly under the FDA’s author­i­ty do not seem to gar­ner the agency’s atten­tion, accord­ing to indus­try experts.

“The FDA has been real­ly, real­ly lax on enforc­ing in dig­i­tal health for rea­sons that are not entire­ly clear to me,” said Bradley Mer­rill Thomp­son, a lawyer at Epstein Beck­er Green who advis­es com­pa­nies on FDA reg­u­la­tions. “Any­body could spend 20 min­utes on the app store and find dozens of exam­ples of apps that make med­ical device claims, and that have been doing so for some time, with­out any effort by the FDA to rein them in.”

In response to ques­tions from KHN about its approach to reg­u­lat­ing men­tal health apps, the FDA sent a brief state­ment. “As cir­cum­stances change and new needs arise, FDA is ready to meet and address these chal­lenges, espe­cial­ly in the areas of men­tal health,” the state­ment reads in part. “We would like to see more evi­dence-based prod­ucts in this area, which is why we remain com­mit­ted to facil­i­tat­ing the devel­op­ment of addi­tion­al safe and effec­tive ther­a­pies for patients who rely on these products.”

Dr. Tom Insel, a psy­chi­a­trist and neu­ro­sci­en­tist, has a unique view of the evolv­ing land­scape. In 2015, Insel left his job as direc­tor of the Nation­al Insti­tute of Men­tal Health, a post he had held since 2002, trad­ing the halls of gov­ern­ment for the open floor plans of Sil­i­con Val­ley to work in dig­i­tal men­tal health. He start­ed at Google’s Ver­i­ly, then co-found­ed Mind­strong Health, a start­up research­ing how smart­phone tech­nol­o­gy could be used to pre­dict and diag­nose men­tal health crises. He has since left to advise Cal­i­for­nia offi­cials on behav­ioral health issues.

Insel said he believes in the promise of dig­i­tal men­tal health but that it will take time to find its high­est and best use. He not­ed, for exam­ple, that most of the apps on the mar­ket focus on the prob­lem of access: They make care more con­ve­nient. But they’re over­look­ing a more basic prob­lem: qual­i­ty. Unlike most fields of med­i­cine, men­tal health providers rarely mea­sure whether the care they pro­vide makes patients better.

“A lot of what we need is not just more access. It’s not just recre­at­ing the brick-and-mor­tar sys­tem and let­ting peo­ple do it by phone or Zoom,” Insel said. Instead, he argued, dig­i­tal health should focus on mea­sur­ing whether treat­ments improve people’s lives.

“I have no doubt that this field will trans­form men­tal health treat­ment and diag­no­sis,” Insel said, “but we’re in the first act of a five-act play. I don’t think we’re any­where near the kinds of solu­tions that we need in the real world.”

Bre­desen no longer says his method can end Alzheimer’s, despite the title of his book. Apol­lo Health’s web­site still makes that claim, however.

– By Jen­ny Gold. This sto­ry was pro­duced by KHN, a nation­al news­room that pro­duces in-depth jour­nal­ism about health issues. Togeth­er with Pol­i­cy Analy­sis and Polling, KHN is one of the three major oper­at­ing pro­grams at KFF (Kaiser Fam­i­ly Foundation). 

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