Psychological Intervention for Distress During HSCT

Psychological Distress Clinical Trial

Official title: Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Haematopoietic Stem Cell Transplantation
• Psychological Distress

• NCT number: NCT02212236
• Study type: Interventional
• Source: University of Nottingham
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Completion date: October 2015