A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
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:
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 investigators' hypotheses are informed by the results of previous research within The Loss Foundation, and previous literature suggesting that online groups may be similarly effective. In regard to the secondary aim of exploring preliminary effectiveness of the study, the investigators hypothesised that grief intensity and PTSD symptoms, depression, and anxiety will be reduced postintervention, and self-compassion will be increased, showing improvement from baseline, compared to the waitlist control. Further, the investigators hypothesise that at follow-up, improvement will be maintained for grief intensity, PTSD symptoms and depression.
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