A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
研究概览
简要总结
Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little empirical evidence for therapist led groups, or for those bereaved by cancer. Objectives: This paper describes the protocol for a pilot feasibility trial evaluating the feasibility, potential effectiveness and acceptability of delivering online therapy groups for those bereaved by cancer. Methods and analysis: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a future definitive RCT. Participants: A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Interventions: An eight-session online therapeutic group intervention led over 12 weeks based on models of cognitive behavioural therapy, compassion focused therapy and coping with bereavement. Primary outcome measures: Cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Acceptability of the intervention will also be measured including what participants found most helpful or unhelpful about the groups and any adverse outcomes. Data collection will occur at baseline, intervention completion and at follow up, 3 months after intervention completion. Results: The feasibility of trial procedures and the effect of the intervention on the outcomes will be tested,. Conclusions: At intervention completion, it is hoped that participants will show reductions across all outcomes measures with improvements remaining at follow up, compared to the waitlist-control group, warranting the need for a full-scale RCT to establish efficacy. Trial registration (intended registry): Protocol version: 1 (No amendments currently), Issued:
详细描述
The loss of a loved one to cancer brings unique difficulties that impact the bereavement experience. Mixed evidence exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to access including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible, destigmatising and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness for online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little (if any) empirical evidence for therapist led groups, or for those bereaved by cancer.
A group bereavement therapy programme was developed by the Loss Foundation, a national cancer bereavement charity, who initiated the project. It will explore the impact of an eight-session therapeutic group intervention led over 12 weeks on cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Previous research within the Loss Foundation has demonstrated the effectiveness of an in-person cancer bereavement therapeutic group using a transdiagnostic model (Jerome et al., 2018). In this study, it was found that grief intensity and symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety were reduced postintervention, and self-compassion increased. At follow-up, improvement remained for grief, PTSD, and depression. This intervention has been adapted and carried out several times from previous research, including methodological changes such as randomisation to a waitlist control and collection of weekly data. For example, previous research within The Loss Foundation explored the effectiveness of the in-person cancer bereavement therapeutic group compared to waitlist control with findings showing a reduction in grief intensity and increased self-compassion.
As this is the first online therapeutic bereavement group for those bereaved by cancer, this study offers a unique contribution to the literature, addressing a critical gap in the literature on evidence-based therapist led internet interventions for cancer bereaved adults. The intention is to ascertain the feasibility, acceptability and changes in self-report measures of the online version of the adapted group bereavement therapy programme for cancer. This feasibility pilot study will evaluate a randomised controlled trial (RCT) design to explore its suitability for a further full-scale RCT. Outcomes will be assessed by comparing intervention and wait-list control groups at baseline, post each session and postintervention 3 months later in terms of the following primary outcomes: grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection.
Aims and objectives
- The primary aim is to evaluate the feasibility and acceptability of delivering online bereavement group for cancer loss. This refers to feasibility to recruit, retain, randomise and acceptability as tracking participant satisfaction and any adverse outcomes.
- The secondary aim is to explore the preliminary effectiveness by examining whether the online bereavement group intervention leads to improvements on various outcomes, compared to the waitlist control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •(1) Adults (aged 18 or over) who are bereaved by cancer, for example losing a partner, family member or friend
- •(2) The time since death must have been more than 6 months, so as not to interfere with a natural recovery process (Henk Schut & Stroebe, 2010)
- •(3) Self-referral to The Loss Foundation or via a related organisation
- •(4) Have the means to access the therapeutic group online
- •(5) Participants consent to attending the intervention with the risk of a delay (e.g. by being randomised to the waitlist or non-waitlist group).
排除标准
- •Adults at high risk to themselves or others in regard to suicide and/or self-harm
- •Significant substance or alcohol misuse which would interfere with participants' ability to take part in the research
- •Cannot be involved in other therapy at the same time elsewhere.
研究组 & 干预措施
Immediate Treatment
Participants randomised to non-waitlist, accessing the online bereavement group intervention immediately
干预措施: Therapeutic - Psychological (Behavioral)
Waitlist-Control Group
participants randomised to waitlist-control accessing the online bereavement group intervention after a delay (three months later) immediate group
干预措施: Therapeutic - Psychological (Behavioral)
结局指标
主要结局
Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
时间窗: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 9-item self-report questionnaire that measures the severity of depressive symptoms. Kroenke et al. (2001) reported that the measure has strong psychometric properties: the internal consistency was 0.89 and test-retest reliability between patient self-report and mental health professional administering the measure telephonically 48 hours later was 0.84. The measure also has good convergent validity (r=0.73) with the mental health subscale of the Short- Form General Health Surv. The PHQ-9 has not been validated with bereaved populations.
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
时间窗: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 7-item self-report questionnaire that measures the severity of anxiety symptoms. Spitzer et al., (2006) reported that the measure has strong psychometric properties: the internal consistency was 0.92 and test-retest reliability was 0.83 over a period of a week. The measure has strong convergent validity with the Beck Anxiety Inventory (r=0.72) and the anxiety sub-scale of the Symptom Checklist-90 (r=0.74). The GAD-7 has not been validated with bereaved populations.
Prolonged Grief Disorder (PG - 13) (Prigerson et al., 2008)
时间窗: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
13-item self-report measure that examines three facets of prolonged grief disorder: feelings, thoughts and actions, occurring over the past month. The measure has strong psychometric properties. For example, Ashouri et al., (2024) found that this measure demonstrated good internal consistency (omega coefficient of 0.93), and test-retest reliability with an interval of 6 weeks being 0.89. The PG-13 was shown to be a reliable scale for the assessment of individuals at risk for developing PGD with high scores on internal consistency in bereaved Swedish parents (Pohlkamp et al., 2018). However, these properties have been validated with a few studies.
PTSD Checklist for DSM-5
时间窗: Baseline (1 week pre-group) Session 4(week 4) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 20-item self-report questionnaire that assesses symptoms of PTSD. Blevins et al., (2015) reported that the measure has strong psychometric properties: when tested with trauma-exposed undergraduate students, the internal consistency was 0.94 and the test-retest reliability was 0.82 over a period of a week. There appears to be no validation of the PCL-5 targeting traumatically bereaved individuals.
The Helpful Aspects of Therapy (HAT; Llewelyn, 1988)
时间窗: Session 1 (Week 1) Session 2 (week 2) Session 3 (week 3) Session 4 (week 4) Session 5 (week 6) Session 6 (week 8) Session 7 (week 10) Session 8 (week 12)
is a post-session self - report questionnaire that asks about perceptions of key change processes in therapy. It is partly qualitative and captures perceptions of helpful and unhelpful aspects of the previous session. It is beyond the scope of this present study to analyse the qualitative data, however this measure provides valuable feedback, which the facilitators can be aware of and address if appropriate. Researchers will aim to foster trusting relationships to help the participants to feel engaged in the research process. Participants will be given opportunities to share their thoughts and reflections during the group to facilitate engagement with the content.
The Self-Compassion Scale (SCS; Neff, 2003)
时间窗: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 26-item self-report questionnaire that measures self-compassion. Raes et al. (2011) reported that the measure has strong psychometric properties: the internal consistency was 0.85 and the test-retest reliability over a period of five months was 0.71. The total score of the SCS-SF correlates highly (r=0.98) with the longer 26-item Self-Compassion Scale. Construct validity of the SCS-SF has not been tested but the long version of the SCS was negatively correlated (r=-0.65) with the self-criticism subscale of the Depressive Experiences Questionnaire. The SCS-SF has not been validated with bereaved populations.
Oxford Grief-Social Disconnection Scale (OG-SD; Smith et al., 2020)
时间窗: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 15-item scale developed from interviews with bereaved individuals. Smith et al., (2020) indicate that internal consistency for the total OG-SD and its subscales were good or excellent (Cronbach alpha 0.80). The OG-SD showed a good 7-day-retest reliability across the total and subscales, indicating a temporally stable assessment of perceived social disconnection (test-retest 0.94). However, although overall the OG-SD was deemed stable over time, other two subscales may be less stable over time. The test-retest sample was also relatively small, which means that it is possible that large effects may have been caused within a few individuals.
次要结局
- - Bereavement characteristics Frequency of seeing deceased in 3 months preceding death(Baseline (1 week pre-group))
- Acceptability- Adverse cirumstances(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Bereavement characteristics Present at the death,(Baseline (1 week pre-group))
- Bereavement characteristics - death of other loved ones in past 3 years.(Baseline (1 week pre-group))
- Recruitment and uptake-Source of referral to the study(Baseline (1 week pre-group))
- Recruitment and uptake- number consenting to participate(Baseline (1 week pre-group))
- Recruitment and uptake- those eligible/willing to be randomised.(Baseline (1 week pre-group))
- Adherence and attrition- A record of participation completion of outcome measurements(Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline))
- Adherence and attrition- Attendance(Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12))
- Acceptability - Intervention(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Acceptability- Intervention Content(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Acceptability- Online modality(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Acceptability- Facilitator effectiveness(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Acceptability- Group size(Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).)
- Demographic Information- Name(Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline))
- Demographic Information- Address(Baseline (1 week pre-group))
- Demographic Information - Age(Baseline (1 week pre-group))
- Demographic Information- Gender(Baseline (1 week pre-group))
- Demographic Information- Ethnicity(Baseline (1 week pre-group))
- Demographic Information- Marital status(Baseline (1 week pre-group))
- Demographic Information- Highest level qualification(Baseline (1 week pre-group))
- Demographic Information- Employment(Baseline (1 week pre-group))
- Demographic Information- Psychological treatment since bereavement(Baseline (1 week pre-group))
- Demographic Information - Gender of deceased(Baseline (1 week pre-group))
- Bereavement characteristics: Length of relationship with deceased(Baseline (1 week pre-group))
- Bereavement characteristics -Time since death(Baseline (1 week pre-group))
- Bereavement characteristics - Relationship with deceased(Baseline (1 week pre-group))
- Bereavement characteristics - Co-habiting with deceased prior to death(Baseline (1 week pre-group))
- Bereavement characteristics - Contact with deceased prior to death(Baseline (1 week pre-group))