Open and Calm A randomized controlled trial investigating a public, meditation-based stress reduction program

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1 Open and Calm A randomized controlled trial investigating a public, meditation-based stress reduction program Christian Gaden Jensen, psykolog, h.d.-stud. Neurobiology Research Unit (nru.dk) & Cognitive Neuroscience Research Unit (cnru.dk)

2 Background rolonged psychosocial stress represents a major challenge for the public health sector There is sound evidence for a good effect of policy investments in mental health promotion initiatives (WHO, 0: Mental Health: Facing the challenges, ISBN X) Multimodal, meditation-based programs reduce stress in healthy samples (Goyal et al., 14, JAMA; Sedlmeier et al., 12, sychological Bulletin) No public, evidence-based stress reduction program for otherwise healthy citizens was available in Denmark

3 The Open and Calm program Simple and evidence-based ONE cognitive framework (Experience-rocessing-articipation-Consequences) C E Stress coping model (simplified) STRESS RESONSE: OEN contrasts with FLIGHT (avoidant, repressive) CALM contrasts with FIGHT (over-active, over-adaptive) MEDITATION: OEN represents attention training (relaxed and receptive CALM represents attitudinal training (non-intervening) Weekly course structure 1: INTROD. 2: BODY : BODY 8: FREELY CHOSEN FUS 3: MIND 6: MIND 9: FREELY CHOSEN FUS 4: SIAL 7: SIAL Course practices Daily meditation ( min) Bodily, cognitive, and social practices ( min) 3

4 The Open and Calm program Simple and evidence-based ONE cognitive framework (Experience-rocessing-articipation-Consequences) Stress coping model (simplified) STRESS RESONSE: OEN contrasts with FLIGHT (avoidant, repressive) CALM contrasts with FIGHT (over-active, over-adaptive) MEDITATION: OEN represents attention training (relaxed and receptive CALM represents attitudinal training (non-intervening) C E Weekly course structure 1: INTROD. 2: BODY : BODY 8: FREELY CHOSEN FUS 3: MIND 6: MIND 9: FREELY CHOSEN FUS 4: SIAL 7: SIAL Course practices Daily meditation ( min) Bodily, cognitive, and social practices ( min) 4

5 The Open and Calm program Simple and evidence-based ONE cognitive framework (Experience-rocessing-articipation-Consequences) Stress coping model (simplified) STRESS RESONSE: OEN contrasts with FLIGHT (avoidant, repressive) CALM contrasts with FIGHT (over-active, over-adaptive) MEDITATION: OEN represents attention training (relaxed and receptive CALM represents attitudinal training (non-intervening) Weekly course structure 1: INTROD. 2: BODY : BODY 8: FREELY CHOSEN FUS 3: MIND 6: MIND 9: FREELY CHOSEN FUS 4: SIAL 7: SIAL C E Course practices Daily meditation ( min) Bodily, cognitive, and social practices ( min)

6 The Open and Calm program Simple and evidence-based ONE cognitive framework (Experience-rocessing-articipation-Consequences) Stress coping model (simplified) STRESS RESONSE: OEN contrasts with FLIGHT (avoidant, repressive) CALM contrasts with FIGHT (over-active, over-adaptive) MEDITATION: OEN represents attention training (relaxed and receptive CALM represents attitudinal training (non-intervening) Weekly course structure 1: INTROD. 2: BODY : BODY 8: FREELY CHOSEN FUS 3: MIND 6: MIND 9: FREELY CHOSEN FUS 4: SIAL 7: SIAL Course practices Daily meditation ( min) Bodily, cognitive, and social practices ( min) C E 6

7 Study design General ractitioners Screening TEST 1 Balancing for age and gender A B C Randomisering O&C indiv. format O&C Group format TEST 2 3-months follow-up 7

8 WHO Quality of Life ittsburg Sleep Quality Index Area Under Curve - Ground (nmol/l) Cohen's erceived Stress Scale SF-36 Mental Component Summary Major Depression Inventory rimary results anel 1. Group comparisons on self-report and cortisol secretion (a) erceived Stress (b) Mental Health (c) Symptoms of Depression (d) Quality of Life (e) Sleep Disturbances (f) Magnitude of Cortisol Secretion (AUC G ) Group Changes re-ost Notes..p<.0..p<.01..p<.001. p-values are two-tailed, corrected for multiple tests (Bonferroni-Holm), and based on intent-to-treat-analyses (Open and Calm [] N=48. Treatment As Usual [] N=24) after adjustment for relevant biological, socioeconomic, and psychological trait variables. Asterisks () above horizontal lines represent p-values of TimeGroup effects, while asterisks or p-values above error bars represent p-values of between-group Center for integrated comparisons (Table 2). Error bars represent 9% CI of the mean. (a). The dotted line represent the mean among a national region-stratified random sample molecular brain imaging

9 WHO Quality of Life ittsburg Sleep Quality Index TVA-Test t 0 score (ms) Cohen's erceived Stress Scale SF-36 Mental Component Summary Major Depression Inventory Supplementary results Supplementary anel 1. Comparisons of interventional formats on self-report and visual perception (a) erceived Stress (b) Mental Health (c) Symptoms of Depression 2 p= p= p= Time oint Time oint Time oint -G -I -G -I -G -I (d) Quality of Life (e) Sleep Disturbances (f) Threshold for Visual erception (t 0 ) p=.08 Time oint p=.114 Time oint Baseline p=.676 Time oint ost-test -G -I -G -I -G -I Center for integrated molecular brain imaging Notes. p-values are two-tailed, corrected for multiple tests (Bonferroni-Holm), and based on intent-to-treat-analyses (Open and Calm for Individuals [-I]

10 Cortisol secretion (nmol/l) Cortisol secretion (nmol/l) TVA-Test t 0 score (ms) Supplementary results Supplementary panel 2. Changes in the slope of cortisol secretion and the threshold for conscious visual perception (a) Curve of Cortisol Secretion (AUC I ) (b) Curve of Cortisol Secretion (AUC I ) (c) Threshold for Visual erception (t 0 ) Wake up 1 min 30 min 4 min 60 min Wake up 1 min 30 min 4 min 60 min Baseline ost-test Cortisol sample Cortisol sample Time oint Baseline osttreatment Baseline osttreatment Notes..p<.0. p-values are two-tailed and based on intent-to-treat-analyses after adjustment for covariates (see "Control variables"). Error bars represent 9% CI of the mean. (a) AUC I decreased significantly for participants with a present (non-blunted) cortisol awakening response (CAR), n=1. (b) AUC I increased significantly for participants with blindly identified blunted baseline CAR, n=18. (c) decreased significantly more than on the threshold for conscious visual perception, t 0, also after control for baseline t 0 score, p=.04 (see text).

11 Final results and conclusions All outcomes indicated significantly larger improvement in than. Completion rate was 94%. Meditation-based courses usually involves 1-30% dropout (Kabat-Zinn, 14; Ospina et al., 07) The mean effect size across all self-report outcomes was similar to or larger than (mean d short term=0.70; long-term=1.03) typically found for programs based on mindfulness meditation, transcendental meditation, and other types of meditation (ds= ) Meta-analyses: Chiesa & Seretti, 09; Grossman et al., 04; Sedlmeier et al., 12; Orme-Johnson et al., 14 RR-MH (Open and Calm) seems effective for stress reduction and mental health promotion. This conclusion is strengthened by the methodological triangulation. Further testing of the potential advantages, including long-term direct effects, of applying the program for public mental health promotion is therefore warranted. Effects were not dependent upon age (medium split), gender, or education (MANOVA across self-report baseline-follow-up-effects, p=.24) Center for integrated molecular brain imaging

12 Open and Calm A randomized controlled trial investigating a public, meditation-based stress reduction program Christian Gaden Jensen, psykolog, h.d.-stud. Neurobiology Research Unit (nru.dk) & Cognitive Neuroscience Research Unit (cnru.dk)