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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
45
Ninety-minute, group-based psychological preparation delivered prior to haematopoietic stem cell transplantation aiming at alleviating psychological distress during the procedure by enhancing perceptions of the procedure and fostering more helpful coping.
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Time frame: Baseline
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Time frame: Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Time frame: Day 14
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Time frame: Day 28
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Time frame: Baseline
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Time frame: Day 0 (transplant day)
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Time frame: Day 14
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Time frame: Day 28
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Time frame: Baseline
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Time frame: Day 0 (transplant day)
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Time frame: Day 14
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Time frame: Day 28
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Time frame: Baseline
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Time frame: Day 0 (transplant day)
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Time frame: Day 14
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Time frame: Day 28
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