Psychological Distress Clinical Trial
Official title:
Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
This Phase II trial aims to evaluate a new psychological intervention to alleviate distress
during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.
HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses.
Over 3,000 individuals undergo the procedure every year in the UK with substantial benefits.
However, it is very costly, intensive, and has a range of debilitating side effects.
Consequently, patients often experience considerable distress, which can impede recovery.
A 90-minute, group-based intervention has been developed to address this need based on
psychological theory of adjustment to illness-related difficulties. It is delivered by the
transplant team and involves provision of information to foster more helpful perceptions
about HSCT and facilitating more helpful coping with its difficulties. To evaluate the
effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT
at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients
in the intervention group will receive the new intervention prior to transplantation
together with treatment as usual (TAU) while patients in the control group will receive TAU
alone. Participants and the researcher collecting the data will be blind to the allocation.
Demographic and relevant clinical information will be recorded at the end of participation
to ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and
procedure-related perceptions will be measured at four time points: (i) prior to the
intervention/transplantation, (ii) day of transplant, (iii) two weeks following the
transplant, and (iv) four weeks following the transplant. It is hypothesised that patients
in the intervention group will experience higher resilience and lower distress compared to
controls and that this difference will be mediated by procedure-related perceptions and
coping. A subgroup of participants of those randomised to the group intervention will be
invited to participate in a feedback interview at the end.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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