Pentecost Claire, Farrand Paul, Greaves Colin J, Taylor Rod S, Warren Fiona C, Hillsdon Melvyn, Green Colin, Welsman Jo R, Rayson Kat, Evans Philip H, Taylor Adrian H
Complex Interventions Research Group, University of Exeter Medical School, South Cloisters 1.32, Heavitree Road, Exeter, EX1 2LU, UK.
Clinical Education Development and Research, Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Exeter, EX4 4QG, UK.
Trials. 2015 Aug 20;16:367. doi: 10.1186/s13063-015-0881-0.
Depression is associated with physical inactivity, which may mediate the relationship between depression and a range of chronic physical health conditions. However, few interventions have combined a psychological intervention for depression with behaviour change techniques, such as behavioural activation (BA), to promote increased physical activity.
To determine procedural and clinical uncertainties to inform a definitive randomised controlled trial (RCT), a pilot parallel-group RCT was undertaken within two Improving Access to Psychological Therapies (IAPT) services in South West England. We aimed to recruit 80 adults with depression and randomise them to a supported, written self-help programme based on either BA or BA plus physical activity promotion (BAcPAc). Data were collected at baseline and 4 months post-randomisation to evaluate trial retention, intervention uptake and variance in outcomes to inform a sample size calculation. Qualitative data were collected from participants and psychological wellbeing practitioners (PWPs) to assess the acceptability and feasibility of the trial methods and the intervention. Routine data were collected to evaluate resource use and cost.
Sixty people with depression were recruited, and a 73 % follow-up rate was achieved. Accelerometer physical activity data were collected for 64 % of those followed. Twenty participants (33 %) attended at least one treatment appointment. Interview data were analysed for 15 participants and 9 study PWPs. The study highlighted the challenges of conducting an RCT within existing IAPT services with high staff turnover and absences, participant scheduling issues, PWP and participant preferences for cognitive focussed treatment, and deviations from BA delivery protocols. The BAcPAc intervention was generally acceptable to patients and PWPs.
Although recruitment procedures and data collection were challenging, participants generally engaged with the BAcPAc self-help booklets and reported willingness to increase their physical activity. A number of feasibility issues were identified, in particular the under-use of BA as a treatment for depression, the difficulty that PWPs had in adapting their existing procedures for study purposes and the instability of the IAPT PWP workforce. These problems would need to be better understood and resolved before proceeding to a full-scale RCT.
ISRCTN74390532 . Registered on 26 March 2013.
抑郁症与身体活动不足有关,身体活动不足可能介导抑郁症与一系列慢性身体健康状况之间的关系。然而,很少有干预措施将针对抑郁症的心理干预与行为改变技术(如行为激活(BA))相结合,以促进身体活动的增加。
为了确定程序和临床方面的不确定性,为一项确定性随机对照试验(RCT)提供信息,在英格兰西南部的两个改善心理治疗可及性(IAPT)服务机构内进行了一项试点平行组RCT。我们的目标是招募80名抑郁症成年人,并将他们随机分配到基于BA或BA加身体活动促进(BAcPAc)的支持性书面自助计划中。在基线和随机分组后4个月收集数据,以评估试验保留率、干预措施的采用情况以及结果的差异,为样本量计算提供信息。从参与者和心理健康从业者(PWPs)收集定性数据,以评估试验方法和干预措施的可接受性和可行性。收集常规数据以评估资源使用和成本。
招募了60名抑郁症患者,随访率达到73%。对64%的随访者收集了加速度计身体活动数据。20名参与者(33%)至少参加了一次治疗预约。对15名参与者和9名研究PWPs的访谈数据进行了分析。该研究突出了在现有IAPT服务机构内进行RCT的挑战,包括员工流动率高和缺勤、参与者安排问题、PWPs和参与者对认知聚焦治疗的偏好,以及与BA实施方案的偏差。BAcPAc干预措施总体上为患者和PWPs所接受。
尽管招募程序和数据收集具有挑战性,但参与者总体上参与了BAcPAc自助手册,并表示愿意增加身体活动。确定了一些可行性问题,特别是BA作为抑郁症治疗方法的使用不足、PWPs在为研究目的调整其现有程序方面的困难以及IAPT PWP劳动力的不稳定性。在进行全面RCT之前,需要更好地理解和解决这些问题。
ISRCTN74390532。于2013年3月26日注册。