“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

The effi­ca­cy of Men­tal Health Apps (phar­mafo­rum):

In Jan­u­ary, PLOS Dig­i­tal Health pub­lished a study which claimed that there’s “sparse” data to sup­port the effi­ca­cy of most men­tal health apps.

In their meta-analy­sis of pub­lished stud­ies, the authors found uni­ver­sal defi­cien­cies and con­clud­ed that there’s no con­vinc­ing evi­dence that app-based inter­ven­tions deliv­er mean­ing­ful out­comes. With­out dig­ging fur­ther, one might think the cur­rent case for dig­i­tal ther­a­peu­tics is weak.

I reviewed all 14 meta-analy­ses includ­ed in the study and found the analy­sis to be accu­rate, but incomplete.

These analy­ses focused exclu­sive­ly on well­ness and smok­ing ces­sa­tion apps, bypass­ing a cat­e­go­ry of dig­i­tal ther­a­peu­tics reg­u­lat­ed by the FDA that make sci­en­tif­i­cal­ly val­i­dat­ed claims using sound research … A meta-analy­sis focused on DTx prod­ucts, like Big Health’s Sleepio, Pear’s reSET, Orexo’s Deprex­is, and Hap­pi­fy Health’s Hap­pi­fy, would reach dif­fer­ent conclusions…

In 2017, pio­neer­ing DTx com­pa­nies cre­at­ed the Dig­i­tal Ther­a­peu­tics Alliance (DTA), a 501(c)(6) non-prof­it trade asso­ci­a­tion focused on pro­vid­ing patients, clin­i­cians, pay­ors, and pol­i­cy­mak­ers with the nec­es­sary tools to eval­u­ate and uti­lize PDTs and NPDTs.

One of their pri­ma­ry ini­tia­tives was to devel­op core prin­ci­ples to which all DTx com­pa­nies should adhere. These include mak­ing claims that are appro­pri­ate for the lev­el of clin­i­cal eval­u­a­tion, and fol­low­ing required reg­u­la­to­ry process­es to sup­port prod­uct claims. More than 40 com­pa­nies have joined the DTA and agreed to these principles.

When you look at the research being con­duct­ed by lead­ing DTA mem­bers, the evi­dence for dig­i­tal ther­a­peu­tics is far more con­vinc­ing. Almost none of the 145 tri­als includ­ed in the meta-analy­sis pub­lished in PLOS Dig­i­tal Health includ­ed stud­ies from DTA members.

(Note: the author is senior direc­tor of research strat­e­gy for Hap­pi­fy Health)

The Study:

Mobile phone-based inter­ven­tions for men­tal health: A sys­tem­at­ic meta-review of 14 meta-analy­ses of ran­dom­ized con­trolled tri­als (PLOS Dig­i­tal Health). From the Abstract:

Mobile phone-based inter­ven­tions have been pro­posed as a means for reduc­ing the bur­den of dis­ease asso­ci­at­ed with men­tal ill­ness. While numer­ous ran­dom­ized con­trolled tri­als and meta-analy­ses have inves­ti­gat­ed this pos­si­bil­i­ty, evi­dence remains unclear. We con­duct­ed a sys­tem­at­ic meta-review of meta-analy­ses exam­in­ing mobile phone-based inter­ven­tions test­ed in ran­dom­ized con­trolled tri­als … The mag­ni­tude of effects and strength of evi­dence tend­ed to dimin­ish as com­par­i­son con­di­tions became more rig­or­ous (i.e., inac­tive to active, non-spe­cif­ic to spe­cif­ic) … Despite sub­stan­tial het­ero­gene­ity, no mod­er­a­tors were iden­ti­fied. Adverse effects were not report­ed. Tak­en togeth­er, results sup­port the poten­tial of mobile phone-based inter­ven­tions and high­light key direc­tions to guide providers, pol­i­cy mak­ers, clin­i­cal tri­al­ists, and meta-ana­lysts work­ing in this area.

News in Context:

• From “Emi­nence-based” to Evi­dence-based men­tal health­care: Time to focus on qual­i­ty and accountability