Impact of Restriction-Resumption Protocols on Mood and Anxiety in Healthy Adults: Randomized Controlled Trial

Clinical Snapshot

Key Findings

• P Value: P < 0.001 for between-group differences at end of phase B

• Effect Size: Large within-group effect sizes: Cohen's d > 1.8 (baseline to end phase B) and d > 1.9 (phase B to post-trial)

• Primary Outcome: Significantly increased depression and anxiety symptoms in intervention group during restriction phase compared to controls

• Nnt Or Sensitivity: Not calculable from available data

• Confidence Interval: Not reported

Clinical Application

Intervention appears feasible as a research tool but clinical utility unclear given temporary symptom worsening Relevant to Australian mental health research and understanding of behavioural interventions; aligns with RACGP emphasis on lifestyle factors in mental health Healthy adults and potentially those with subclinical anxiety or depression symptoms

Abstract

BACKGROUND: Simple behavioral and cognitive actions can reduce symptoms of anxiety and depression. However, there is limited research investigating whether restricting those same actions increases symptoms and whether resuming those actions reduces symptoms. OBJECTIVE: The primary aim was to examine the impact of restricting, then resuming (the "restriction-resumption protocol"), 5 groups of actions called the Things You Do (TYD), on symptoms of depression and anxiety. Participant satisfaction with life and perceptions of changes in behavior and mental health were also evaluated. METHODS: In total, 70 adults were randomly allocated to an intervention group (IG) or a control group (CG). IG participants completed a 3-phase protocol over 8 weeks: a 2-week baseline period (phase A), 2 weeks of restricted TYD actions (phase B), and a 4-week resumption phase (phase C). CG participants were instructed to maintain their usual activities and routines. Primary outcomes included symptoms of depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and frequency of TYD actions. Secondary outcomes included satisfaction with life and perceived changes in mental well-being. Outcomes were measured weekly throughout the 8-week trial and again after the trial at week 9. RESULTS: Scores on outcome measures did not differ between groups during phase A and after the trial. However, by the end of phase B, IG participants showed significantly increased symptoms of depression and anxiety compared to CG participants (Ps<.001). Large within-group effect sizes were observed on the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 from baseline to the end of phase B (Cohen d>1.8) and from phase B to after the trial (Cohen d>1.9). Changes in satisfaction with life and evaluations of mental health corresponded with symptom changes. CONCLUSIONS: These findings demonstrate a relationship between the frequency of performing specific actions and symptoms of depression and anxiety. The restriction-resumption protocol has the potential to increase our understanding of causal mechanisms underlying common mental disorders and may lead to the development of new models of prevention and treatment. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12624001491550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388828&isReview=true.

References

1. 1.Titov, N., Dagnall, A., Fisher, A., Nielssen, O., Kayrouz, R., Jones, M., Hadjistavropoulos, H., Rock, D., Staples, L., & Dear, B. (2026). Impact of Restriction-Resumption Protocols on Mood and Anxiety in Healthy Adults: Randomized Controlled Trial. JMIR Formative Research. https://doi.org/10.2196/90532