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Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
Sponsor study identifier
interventional
45
1 country
2
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2014
Actual (reported)August 8, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Actual (reported)October 2015
Actual (reported)Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Baseline
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 14
TAU=treatment as usual
Usual care including medication, nursing, and psychologist support.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Thomas Schröder, PhD
University of Nottingham
45 participants (actual enrollment reported by the registry).
First Submitted
August 4, 2014
First Posted
August 8, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 28
Brief Resilience Scale (BRS)
Baseline
Brief Resilience Scale (BRS)
Day 0 (transplant day)
Brief Resilience Scale (BRS)
Day 14
Brief Resilience Scale (BRS)
Day 28
Brief Coping with Problems Experienced scale (COPE)
Baseline
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
October 28, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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