Bureaucratic creep does damage.
There are moments when the USA makes no sense. No sense at all. CBT is not licensed in a matter akin to a drug, and the Australian Government has been funding these programs for some years. But the states wants to regulate such.
As if us Antipodeans are not to be trusted: or because we it was not invented in the USA. What it does mean is that American people who could benefit from this modality would do better to use an Australian site, where there is an evidence base.
“This is the first piece of software cleared by the FDA to treat any disease,” said Corey McCann, M.D., president and CEO of Pear Therapeutics.
reSET is a 12-week digital therapeutic that is meant to be used in conjunction with standard outpatient treatment for alcohol, cocaine, marijuana, and stimulant SUDs to improve treatment retention and enhance abstinence.
This software program combines a mobile app for patients, which includes interactive modules and assessments, with a desktop program for the clinician to view analytics and monitor patient progress. The modules on the patient side provide neurobehavioral support using the Community Reinforcement Approach (CRA) model. CRA is a form of cognitive-behavioral therapy that combines social reinforcement and other incentives to encourage and increase satisfaction with drug-free sources of reward.
The reSET app is only available to patients by prescription. Physicians can prescribe 90-day access to reSET in the form of a code that the patient enters after he or she downloads the app.
The primary support for reSET came from a multisite clinical study. As described in the June 2014 issue of the American Journal of Psychiatry, this trial included over 500 adults with an SUD who were participating in an outpatient treatment program. The participants were randomly assigned to receive either 12 weeks of usual care (including both individual and group counseling) or usual care plus reSET, with the digital intervention substituting for two hours of counseling time each week.
At the study’s end, the patients with alcohol, cocaine, marijuana, and/or stimulant disorders who used reSET had a lower dropout rate and were about twice as likely to be abstinent (58.1 percent versus 29.8 percent for usual care). The intervention was especially effective for patients with a poor prognosis (those who had a positive drug screen at the start of the study), as they showed nearly five-fold increased abstinence compared with usual care.
I do have skin in this game: I have developed a staff education programme, and I know most of the Australian researchers in this field. We are dealing with peers who do not accept such data because they see Australia as too small, and conflicts of interest. But the costs of not having digital CBT are the costs of delay: the increased mortality and morbidity, for the one thing we know from psychotherapy trials is that the wait list condition does worse than any other.
Without dCBT, now proven and in clinical use elsewhere, you have wait lists. In my mind, this is an ethical challenge — even if dCBT is no more effective than a psychological placebo. But the data indicates there is equivalence between face to face and digital CBT.