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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212236
• Other study ID #: 14069
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2014
• Last updated: October 27, 2015
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients referred for HSCT as treatment for haematological malignancy

• age of 18 years or older

• sufficient command of the English language or access to suitable support to comprehend materials and participate in the group and data collection over the telephone

• informed consent

• permission will also be sought by the patient's Consultant Haematologist once clients have consented

Exclusion Criteria:

• Consent withdrawn

• Consultant Haematologist raises concern regarding participation

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

Intervention

Other:
• Psychological preparation
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.

Locations

Country	Name	City	State
United Kingdom	Nottingham City Hospital	Nottingham	Nottinghamshire
United Kingdom	Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham University Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Anxiety Stress Scales (DASS-21)	Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.	Baseline	No
Primary	Depression Anxiety Stress Scales (DASS-21)	Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.	Day 0 (transplant day)	No
Primary	Depression Anxiety Stress Scales (DASS-21)	Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.	Day 14	No
Primary	Depression Anxiety Stress Scales (DASS-21)	Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.	Day 28	No
Secondary	Brief Resilience Scale (BRS)	Assesses resilience; 6 items, Likert-type.	Baseline	No
Secondary	Brief Resilience Scale (BRS)	Assesses resilience; 6 items, Likert-type.	Day 0 (transplant day)	No
Secondary	Brief Resilience Scale (BRS)	Assesses resilience; 6 items, Likert-type.	Day 14	No
Secondary	Brief Resilience Scale (BRS)	Assesses resilience; 6 items, Likert-type.	Day 28	No
Secondary	Brief Coping with Problems Experienced scale (COPE)	Assesses coping styles; 28-item, Likert-type.	Baseline	No
Secondary	Brief Coping with Problems Experienced scale (COPE)	Assesses coping styles; 28-item, Likert-type.	Day 0 (transplant day)	No
Secondary	Brief Coping with Problems Experienced scale (COPE)	Assesses coping styles; 28-item, Likert-type.	Day 14	No
Secondary	Brief Coping with Problems Experienced scale (COPE)	Assesses coping styles; 28-item, Likert-type.	Day 28	No
Secondary	Brief Illness Perceptions Questionnaire (IPQ)	Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.	Baseline	No
Secondary	Brief Illness Perceptions Questionnaire (IPQ)	Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.	Day 0 (transplant day)	No
Secondary	Brief Illness Perceptions Questionnaire (IPQ)	Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.	Day 14	No
Secondary	Brief Illness Perceptions Questionnaire (IPQ)	Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.	Day 28	No