Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial

Abstract

Background: There is certain evidence on the efficacy of smartphone-based mental health interventions. However, the mechanisms of action remain unclear. Placebo effects contribute to the efficacy of face-to-face mental health interventions and may also be a potential mechanism of action in smartphone-based interventions.

Objective: This study aimed to investigate whether different types of efficacy expectancies as potential factors underlying placebo effects could be successfully induced in a smartphone-based digital placebo mental health intervention, ostensibly targeting mood and stress.

Methods: We conducted a randomized, controlled, single-blinded, superiority trial with a multi-arm parallel design. Participants underwent an Android smartphone-based digital placebo mental health intervention for 20 days. We induced prospective efficacy expectancies via initial instructions on the purpose of the intervention and retrospective efficacy expectancies via feedback on the success of the intervention at days 1, 4, 7, 10, and 13. A total of 132 healthy participants were randomized to a prospective expectancy-only condition (n=33), a retrospective expectancy-only condition (n=33), a combined expectancy condition (n=34), or a control condition (n=32). As the endpoint, we assessed changes in efficacy expectancies with the Credibility Expectancy Questionnaire, before the intervention and on days 1, 7, 14, and 20. For statistical analyses, we used a random effects model for the intention-to-treat sample, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs no) and retrospective expectancy (yes vs no), allowed to vary over participant and intervention day.

Results: Credibility (β=-1.63; 95% CI -2.37 to -0.89; P<.001) and expectancy (β=-0.77; 95% CI -1.49 to -0.05; P=.04) decreased across the intervention days. For credibility and expectancy, we found significant three-way interactions: intervention day×prospective expectancy×retrospective expectancy (credibility: β=2.05; 95% CI 0.60-3.50; P=.006; expectancy: β=1.55; 95% CI 0.14-2.95; P=.03), suggesting that efficacy expectancies decreased least in the combined expectancy condition and the control condition.

Conclusions: To our knowledge, this is the first empirical study investigating whether efficacy expectancies can be successfully induced in a specifically designed placebo smartphone-based mental health intervention. Our findings may pave the way to diminish or exploit digital placebo effects and help to improve the efficacy of digital mental health interventions.

Trial registration: Clinicaltrials.gov NCT02365220; https://clinicaltrials.gov/ct2/show/NCT02365220.

Keywords: digital placebo effect; ecological momentary assessment; efficacy expectancies; mHealth; mobile phone; placebo effect; randomized controlled trial; smartphone-based intervention.

Figure 1

Fourfold table of different conditions.

Figure 2

Flow of study participants. Note: as part of our intention-to-treat analyses, we included all study participants in our main analyses who were randomized to one of the 4 conditions.

Figure 3

Time trajectories of credibility throughout intervention days (means). Note: means were calculated based on existing values.

Figure 4

Time trajectories of expectancy throughout intervention days (means). Note: means were calculated based on existing values.