A first US study demonstrated the feasibility, relative safety, and potential efficacy of psilocybin-assisted group therapy for demoralisation in older, long-term AIDS survivors (OLTAS).
Psychedelic-assisted therapy has been showing great promise for some of our most intractable psychiatric conditions, as was presented at a recent Psych Congress Institute for Psychedelic Education Preconference. Phase 3 trials of MDMA-assisted therapy for PTSD are currently underway, and two companies, Usona Institute and Compass Pathways have begun late Phase 2/early Phase 3 trials of psilocybin for depression.
As we prepare for the day when these treatments become US Food and Drug Administration (FDA) approved and available to our patients, there is increasing discussion about how to make the treatments accessible and affordable.
These drugs are catalysts to psychotherapy, but current study designs require about 40-50 hours of therapist time, usually doubled, as there are typically two therapists present for the psychotherapy.
Even at a modest $150 per hour, this is about $15,000 of psychotherapy services, not counting administrative time or the cost of the drug. While those of us doing clinical work with patients might note that $15,000 is the cost of a couple of years of psychotherapy or a single psychiatric hospitalisation and see this up-front cost of effective psychedelic psychotherapy as a long-term cost savings, it is unlikely that health insurers will share our view. And if the current cost models extend into clinical practice guidelines, we will likely see restrictions placed upon who can receive psychedelic therapies, reserving the treatment for only the most refractory cases.
This is why the first contemporary study of group therapy utilising psychedelic medicine, by Brian Anderson and his colleagues at University of California-San Francisco (UCSF), is so important. In their study, they worked with an underserved population – long-term, gay-identified, male HIV survivors who were experiencing demoralisation.
These were men, many of whom had lived through the “plague years” of HIV/Aids (the average duration of infection was over 30 years) and lost, on average, 17 people close to (the range was 2-100 people lost per subject).
Many subjects had expected to succumb to Aids themselves but were surprised to respond robustly to antiretroviral medications that became available in 1996. This was a group that was ageing (nearing 60) with many of their friends, partners and community gone. Many reported feeling hopeless, helpless and without purpose in life – in other words, demoralised.
While demoralisation is not a DSM diagnosis, it is a common phenomenon of people dealing with chronic or life-threatening illnesses. In their open-label pilot study, the subjects, all gay-identified men, met as a group four times before receiving a single psilocybin-assisted therapy session (the psilocybin sessions were done individually, not as a group). Following the psilocybin-assisted therapy session, the group reconvened for 4-6 more sessions of integration psychotherapy.
The results were impressive. The primary outcome, the demoralisation scale (2nd version), scores were clinically reduced at the end of study and at the 3-month follow-up (mean difference – 5.78 (SD 6.01) with an effect size hp2=0.47, 90% CI 0.21-0.60 for change over the 3-month period of the study. Secondary measures, the PTSD Checklist (PCL5) and the Inventory of Complicated Grief also showed significant reductions that endured over time.
The psilocybin sessions were physiologically safe, with transient increases in hypertension and heart rate not requiring medical intervention. Psilocybin sessions, as shown in other studies, can be psychologically challenging at times, with transient emergence of anxiety and paranoia. When the treatment is safely ensconced in the vessel of a psychotherapeutic relationship, these adverse effects can be managed with reassurance and not require psychiatric hospitalisation or medication. There was no detected worsening of alcohol or drug use in participants and there was no worsening of suicidal ideation during the study. The vast majority of subjects reported their experience as extremely beneficial.
The study is notable for its population, methods and outcome measure. Psychedelic studies have rightly been criticised for their lack of inclusivity of underrepresented groups, limiting their generalisability should they gain FDA approval. While over three-quarters of the subjects in this study identified as White, the choice to treat a specifically gay-identified, HIV-positive population that has historically endured discrimination and stigma is a novel one.
Targeting demoralisation with a psychedelic psychotherapy broadens the utility of these compounds. While demoralisation may not be a DSM diagnosis by itself, it is likely a component of many psychiatric diagnoses, particularly those that have a chronic course, and may also accompany those struggling with chronic and/or stigmatising physical illnesses like HIV/Aids. We are reminded that while the DSM may be a useful map of our concepts of mental ailments, it is incomplete, and the territory through which we and our patients must traverse includes the terrain of demoralisation and existential despair.
It is promising that the meaning-making experiences often occasioned by psychedelic-assisted therapy may address these concerns in ways that existing psychopharmacology may not. Jerome Frank (author of Persuasion and Healing) posited over 50 years ago that demoralisation is the main target of all psychotherapies. Demoralisation is a construct that could be considered in assessing benefit from other forms of psychotherapy.
Additionally, the use of group psychotherapy pioneered several possibilities for this burgeoning field. Study subjects reported that being able to discuss their life experiences with others who were also gay and living with HIV reduced their experiences of shame.
Group psychotherapy represents a more efficient means of delivering therapy to more people in the same amount of time, and therefore is more cost-effective, it also has the advantage of creating a de facto community among people enduring a common experience, in this case, long-term HIV infection. Many of the men reported feeling isolated in their experience of having HIV and carrying grief for many years from the time when so many were lost to the virus.
Psychedelics often have the experience of creating unity experiences, that is, a felt sense of the lifting of the psychic barriers we put between ourselves and others. If demoralization is, in part, a profound sense of isolation, loneliness and disconnection, it is reasonable to consider how a carefully delivered psilocybin experience in a group may serve as a counterweight to that loneliness and separation.
Many healthcare delivery systems, such as the Veterans Administration and Kaiser Permanente, have leveraged group therapy as both a means of increasing access to mental health services and controlling costs, but also allowing patients suffering from mental illnesses that often isolate them from others to access to a community of like-minded others. Psychedelic-assisted group therapy may someday help to improve access, lower cost, and provide for our need for a connection with a larger community.
Background: Psilocybin therapy has shown promise as a rapid-acting treatment for depression, anxiety, and demoralization in patients with serious medical illness (e.g., cancer) when paired with individual psychotherapy. This study assessed the safety and feasibility of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with a high degree of demoralization and traumatic loss.
Methods: Self-identified gay men OLTAS with moderate-to-severe demoralization (Demoralization Scale-II ≥8) were recruited from the community of a major US city for a single-site open-label study of psilocybin-assisted group therapy comprising 8–10 group therapy visits and one psilocybin administration visit (0·3–0·36 mg/kg po). Primary outcomes were rate and severity of adverse events, and participant recruitment and retention. The primary clinical outcome was change in mean demoralization from baseline to end-of-treatment and to 3-month follow-up assessed with a two-way repeated measures ANOVA. Trial registration: Clinicaltrials.gov (NCT02950467)
Findings: From 17 July 2017 to 16 January 2019, 18 participants (mean age 59·2 years (SD 4·4)) were enrolled, administered group therapy and psilocybin, and included in intent-to-treat analyses. We detected zero serious adverse reactions and two unexpected adverse reactions to psilocybin; seven participants experienced self-limited, severe expected adverse reactions. We detected a clinically meaningful change in demoralization from baseline to 3-month follow-up (mean difference -5·78 [SD 6·01], ηp2 = 0·47, 90% CI 0·21–0·60).
Interpretation: We demonstrated the feasibility, relative safety, and potential efficacy of psilocybin-assisted group therapy for demoralization in OLTAS. Groups may be an effective and efficient means of delivering psychotherapy pre- and post-psilocybin to patients with complex medical and psychiatric needs.
Funding: Carey Turnbull, Heffter Research Institute, NIMH R25 MH060482, NIH UL1 TR001872, River Styx Foundation, Saisei Foundation, Sarlo Foundation, Stupski Foundation, Usona Institute, US Department of Veterans Affairs
Brian T Anderson, Alicia Danforth, Robert Daroff, Christopher Stauffer, Eve Ekman, Gabrielle Agin-Liebes, Alexander Trope, Matthew Tyler Boden, James Dilley, Jennifer Mitchell, Joshua Woolley
Psych Congress material eClinical Medicine abstract