A Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Acceptance and Action Questionnaire
研究概览
简要总结
A randomised wait-list-controlled trial is being run in a psychology department research clinic at a London University providing two four-week group interventions (one Acceptance and Commitment Therapy (ACT) and one MBSR-informed) to students presenting with mild to moderate anxiety. Pre and post measures of anxiety, depression, psychological flexibility, mindfulness, self-compassion, letter-number sequencing and trail making will be collected. Groups will be audio recorded for qualitative analysis and long term follow up outcomes will be collected.
详细描述
This pilot study is designed as a randomised controlled trial comparing the effectiveness of two group interventions to a waitlist control (WLC) group: The first group is informed by Acceptance and Commitment Therapy (ACT), and the second group is informed by Mindfulness-Based Stress Reduction (MBSR). Student participants in the intervention groups will take part in either four 2-hour group sessions of ACT or MBSR-informed group interventions. Participants who are placed on the waitlist will be offered either brief ACT or brief MBSR-informed groups after 4 weeks. Both intervention and WLC groups will be administered an assessment battery before the interventions start (baseline), and soon after the intervention (post-intervention). All participants will complete the assessment battery measures at 8 weeks after post-measurement (4-week follow-up). After the completion of the 4-week follow-up measures, participants in the WLC group will be randomly allocated to either intervention groups, followed up by a post-measurement 4 weeks later after the completion of each intervention.
METHODS Therapeutic interventions: Participants of the intervention groups will be randomly allocated into either a 4- week ACT or MBSR-informed group. Instructions will be offered by the group facilitators, including discussion, reading assignments, as well as training and practice in a variety of acceptance- and mindfulness-based techniques.
ACT GROUP The ACT protocol proposed in this study has been adapted from a manual developed by Flaxman, McIntosh and Oliver (2018) for ACT training in workplace settings. This protocol has been adapted further by the authors in collaboration with Dr Kornilia Givissi and Dr Hana Villar for use in clinical settings and specifically applied to participants struggling with anxiety. This intervention combines psychoeducational and experiential practices to introduce concepts and develop skills in the six core processes of ACT. Participants will attend 4 two-hour weekly sessions of this group. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the ACT protocol MBSR-INFORMED GROUP The 4-week MBSR protocol proposed in this study has been adapted from the work of Kabat-Zinn (1990), Segal, Williams, and Teasdale (2002) and has been adapted by Dr Trudi Edginton, an experienced mindfulness teacher. It has synthesised the main elements, includes all of the traditional practices and is congruent with the philosophical underpinning of the original MBSR group. This group consists of 4 two-hour weekly sessions. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the MBSR-informed protocol .
Waitlist Control (WLC) group: Those assigned to the WLC group will not engage in the group interventions during the course of the intervention period. At the start of the pilot trial, they will be informed of the 4-week waiting period after which they will be randomly allocated into either intervention groups. They will be asked to complete the assessment battery measures at baseline and all follow-up timepoints.
Researcher/Practitioners: The ACT or MBSR-informed protocols in this study will be delivered by qualified and HCPC registered counselling and/or clinical psychology practitioners and are either employed or visiting lecturers in the Department of Psychology. They will all have received training in ACT and/or MBSR, and will undertake weekly clinical peer supervision to ensure fidelity to the intervention models. The research will be evaluated by the named staff members on this application and will not provide interventions but supervision to those delivering the protocols to the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate anxiety
排除标准
- •dissociation
结局指标
主要结局
Acceptance and Action Questionnaire
时间窗: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. .
The Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) measures psychological inflexibility or experiential avoidance.This 7-item one-factor scale is scored by adding together the seven items.Higher scores equal greater levels of psychological inflexibility. Measuring change in Psychological Flexibility.
Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
时间窗: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up
CompACT; Francis, Dawson \& Golijani-Moghaddam, 2016) was developed as a general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.This 23-item measure has shown initial advantages to the AAQ-II and its inclusion is intended to further test its validity. Measuring change in psychological Psychological flexibility
Five Facet of Mindfulness Questionnaire (FFMQ) - SHORT FORM
时间窗: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up
The Five Facet of Mindfulness Questionnaire (FFMQ; Bohlmeijer, Ten Klooster, Fledderus,Veehof,\& Baer, 2011) is a 39-item measure consisting of five subscales (1. observing, 2. describing, 3. acting with awareness, 4. non-judging of inner experience, and 5. non-reactivity to inner experience). The FFMQ short-version (24 items) has been used.The FFMQ short-version (24 items) captures 4 of the psychological flexibility processes: contact with the present moment; cognitive defusion; self as context; acceptance.Items of the FFMQ were measured on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). A global FFMQ score are calculated using the mean of all 24 items (considering reverse-scoring). Measuring changes in mindfulness
Generalised Anxiety Disorder Assessment (GAD-7)
时间窗: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up
The Generalised Anxiety Disorder Assessment (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006) is used to measure or assess the severity of generalised anxiety disorder (GAD) This self-administered instrument has 7 items. Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day" respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21. Scores represent: 0-5 = Mild anxiety, 6-10 = Moderate anxiety, 11-15 = Moderately severe anxiety, and 15-21 = Severe anxiety. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Measuring changes in anxiety scores.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up
The Patient Health Questionnaire-9 (PHQ-9; Kroenke \& Spitzer, 2002) is used to measure or assess the severity of depression. This self-administered scale has 9 items. Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day" respectively, and then adding together the scores for the seven questions. Scores represent: 5-9 = mild depression / low mood, 0-14 - moderate depression / low mood, 15-19 - moderately severe depression / low mood, and 20-27 - severe depression/low mood. Measuring change in scores of low mood. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
次要结局
- Ruminative Responses Scale(This measure was collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group.)
- Self compassion scale(Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group.)
- Trail making test(Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group.)
- WAIS-1V Letter-number sequencing(Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group.)
- student engagement scale(Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group.)