Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.
JAMA Netw Open. 2021 Mar 1;4(3):e211020. doi: 10.1001/jamanetworkopen.2021.1020.
Caregivers of people with mental illness are at increased risk of developing depression, anxiety, and stress.
To investigate the effect of a compassion cultivation training (CCT) program on decreasing caregiver psychological distress.
DESIGN, SETTING, AND PARTICIPANTS: This waitlist-controlled randomized clinical trial was conducted in 2 different community settings in Denmark. Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment. Enrollment occurred between May 2018 and March 2019. A repeated measurement model was used to examine the impact of the intervention. The primary analysis was based on the intention-to-treat principle. Data analysis was conducted from June 4 to July 7, 2020.
Participants were randomized 1-to-1 to an 8-week CCT course or waitlist control. Block randomization was used with 40 participants in each block.
The main outcome was reduction in psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS). Baseline, postintervention, and 3- and 6-month follow-up measurements were collected.
Among 192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the CCT intervention and 82 participants in the waitlist control group. At baseline, the mean (SD) DASS scores for the intervention vs control groups were 10.89 (8.66) vs 10.80 (8.38) for depression, 6.89 (6.48) vs 6.68 (5.33) for anxiety, and 14.96 (7.90) vs 15.77 (7.40) for stress. The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24 [95% CI, -3.99 to -0.48]; P = .01; stress, -4.20 [95% CI, -6.73 to -1.67]; P = .001), the 3-month follow-up (adjusted mean difference: depression, -3.78 [95% CI, -6.40 to -1.17]; P = .005; anxiety, -2.50 [95% CI, -4.27 to -0.73]; P = .006; stress, -3.76 [95% CI, -6.32 to -1.21]; P = .004), and the 6-month follow-up (adjusted mean difference: depression: -4.24 [95% CI, -6.97 to -1.52]; P = .002; anxiety, -2.12 [95% CI, -3.96 to -0.29]; P = .02; stress: -3.79 [95% CI, -6.44 to -1.13]; P = .005).
These findings suggest that CCT was superior to the waitlist control in supporting caregivers' mental health. Statistically and clinically significant reductions in psychological distress were found and sustained at the 6-month follow-up. The improvements noted in this randomized clinical trial could serve to encourage implementation of future evidence-based programs for caregivers.
ClinicalTrials.gov Identifier: NCT03730155.
精神疾病患者的照顾者面临更高的抑郁、焦虑和压力风险。
调查同情培养培训（CCT）计划对降低照顾者心理困扰的效果。
设计、地点和参与者：这是一项在丹麦两个不同社区环境中进行的等待名单对照随机临床试验。如果照顾者患有未经诊断和未经治疗的精神疾病、成瘾、冥想练习或当前的心理治疗，将被排除在外。招募工作于 2018 年 5 月至 2019 年 3 月进行。采用重复测量模型来检验干预的影响。主要分析基于意向治疗原则。数据分析于 2020 年 6 月 4 日至 7 月 7 日进行。
参与者随机 1:1 分为 CCT 课程或等待名单对照组。采用 40 名参与者一组的块随机化。
主要结局是通过抑郁、焦虑、压力量表（DASS）测量的心理困扰减少。收集基线、干预后以及 3 个月和 6 个月的随访测量结果。
在评估合格性的 192 名参与者中，161 名参与者被纳入研究（平均[标准差]年龄为 52.6[12.5]岁；142[88.2%]名女性），其中 79 名参与者随机分配到 CCT 干预组，82 名参与者分配到等待名单对照组。在基线时，干预组和对照组的 DASS 评分平均值（标准差）分别为抑郁：10.89（8.66）vs 10.80（8.38）；焦虑：6.89（6.48）vs 6.68（5.33）；压力：14.96（7.90）vs 15.77（7.40）。CCT 组在干预后的主要结局方面从基线到对照组有统计学意义的改善（调整后的平均差异：抑郁：-4.16[95%置信区间，-6.75 至-1.58]；P=0.002；焦虑：-2.24[95%置信区间，-3.99 至-0.48]；P=0.01；压力：-4.20[95%置信区间，-6.73 至-1.67]；P=0.001），在 3 个月随访时（调整后的平均差异：抑郁：-3.78[95%置信区间，-6.40 至-1.17]；P=0.005；焦虑：-2.50[95%置信区间，-4.27 至-0.73]；P=0.006；压力：-3.76[95%置信区间，-6.32 至-1.21]；P=0.004），在 6 个月随访时（调整后的平均差异：抑郁：-4.24[95%置信区间，-6.97 至-1.52]；P=0.002；焦虑：-2.12[95%置信区间，-3.96 至-0.29]；P=0.02；压力：-3.79[95%置信区间，-6.44 至-1.13]；P=0.005）。
这些发现表明，CCT 在支持照顾者的心理健康方面优于等待名单对照组。在统计学和临床上都发现了心理困扰的显著减少，并在 6 个月的随访中得到了持续。这项随机临床试验中注意到的改善可以鼓励实施未来针对照顾者的循证计划。
ClinicalTrials.gov 标识符：NCT03730155。
