Brief Digital Interventions for Psychological Distress: An AI-Enhanced
Response-Adaptive Randomized Clinical Trial
#MMPMID41171275
Newby J
; Gupta S
; Hoon L
; Zheng W
; Whitton AE
; Huckvale K
; Stech E
; Mackinnon A
; Senadeera M
; Shvetcov A
; Berk J
; Slade A
; Spoelma MJ
; Han J
; Beames JR
; Logothetis R
; Dabash O
; Kurniawan S
; Vasa R
; Mouzakis K
; Cameron S
; Agarwal A
; Asbury J
; Funke Kupper J
; Werner-Seidler A
; Rosenbaum S
; Cutler H
; Venkatesh S
; Christensen H
JAMA Netw Open
2025[Oct]; 8
(10
): e2540502
PMID41171275
show ga
IMPORTANCE: A large proportion of college students report experiencing
psychological distress. Smartphone app-based interventions may alleviate
distress, but their effectiveness across severity levels is unclear. Artificial
intelligence (AI)-enhanced response-adaptive randomized clinical trials may offer
an efficient method to evaluate competing interventions. OBJECTIVE: To compare
the effectiveness of 3 brief, 2-week self-guided smartphone application-based
interventions (physical activity, mindfulness, sleep hygiene) or an active
control (ecological momentary assessment [EMA]) for reducing psychological
distress among college students with mild, moderate, or severe distress. DESIGN,
SETTING, AND PARTICIPANTS: This population-based AI-enhanced response-adaptive
randomized clinical trial included 1282 participants with distress scores of 20
or more on the 10-item Kessler Psychological Distress Scale in 12 minitrials from
November 9, 2021, with final follow-up on February 17, 2023. Participants'
distress was categorized as mild, moderate, or severe based on their normalized
21-item Depression Anxiety Stress Scale (DASS-21) scores at screening.
INTERVENTIONS: After a 2-week onboarding period of daily EMA, participants were
assigned by a contextual multi-armed bandit algorithm to 1 of 4 two-week
self-guided app interventions: physical activity, mindfulness, sleep hygiene, or
a control that continued EMA. MAIN OUTCOMES AND MEASURES: The primary outcome was
change in psychological distress (DASS-21 total score) from week 2 (before
intervention) to week 4 (after intervention). The primary end point was after the
intervention (4 weeks). Secondary outcomes included DASS-21 subscale scores,
self-reported physical activity, mindfulness, sleep quality, and app engagement,
usability, and satisfaction. Analysis was performed on an intention-to-treat
basis. RESULTS: A total of 1282 individuals (mean [SD] age, 23.5 [5.2] years; 950
women [74.1%]) participated: physical activity (n?=?305), mindfulness (n?=?453),
sleep hygiene (n?=?431), or a control that continued EMA (n?=?93). Among 349
participants with severe distress, physical activity (n?=?79) and mindfulness
(n?=?180) were significantly more effective than the EMA control (n?=?29) in
reducing DASS-21 total scores (physical activity vs control: standardized mean
difference [SMD], 0.62 [95% CI, 0.23-1.02]; mindfulness vs control: SMD, 0.53
[95% CI, 0.19-0.87]) and sleep hygiene (n?=?61) (physical activity vs sleep
hygiene: SMD, 0.50 [95% CI, 0.16-0.84]; mindfulness vs sleep hygiene: SMD, 0.41
[95% CI, 0.13-0.69]). Among 494 participants with mild distress, physical
activity (n?=?161) and sleep hygiene (n?=?224) were significantly more effective
than control (n?=?37) in reducing DASS-21 total scores (physical activity vs
control: SMD, 0.58 [95% CI, 0.30-0.86]; sleep hygiene vs control: SMD, 0.47 [95%
CI, 0.20-0.73]). No significant group differences were observed among
participants with moderate distress (n?=?439). CONCLUSIONS AND RELEVANCE: In this
AI-enhanced response-adaptive randomized clinical trial among college students,
physical activity and mindfulness were most effective for severe distress, while
physical activity and sleep hygiene were most effective for mild distress. These
findings can guide personalized mental health interventions for college students.
This trial improved efficiency by minimizing control group allocation but had
reduced power to detect significant group differences. TRIAL REGISTRATION:
http://anzctr.org.au Identifier: ACTRN12621001223820.
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