Psychological Intervention for Distress During HSCT

October 27, 2015 updated by: University of Nottingham

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham City Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological preparation + TAU
TAU=treatment as usual
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.
No Intervention: Treatment as usual
Usual care including medication, nursing, and psychologist support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scales (DASS-21)
Time Frame: Baseline
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Baseline
Depression Anxiety Stress Scales (DASS-21)
Time Frame: Day 0 (transplant day)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21)
Time Frame: Day 14
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 14
Depression Anxiety Stress Scales (DASS-21)
Time Frame: Day 28
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Resilience Scale (BRS)
Time Frame: Baseline
Assesses resilience; 6 items, Likert-type.
Baseline
Brief Resilience Scale (BRS)
Time Frame: Day 0 (transplant day)
Assesses resilience; 6 items, Likert-type.
Day 0 (transplant day)
Brief Resilience Scale (BRS)
Time Frame: Day 14
Assesses resilience; 6 items, Likert-type.
Day 14
Brief Resilience Scale (BRS)
Time Frame: Day 28
Assesses resilience; 6 items, Likert-type.
Day 28
Brief Coping with Problems Experienced scale (COPE)
Time Frame: Baseline
Assesses coping styles; 28-item, Likert-type.
Baseline
Brief Coping with Problems Experienced scale (COPE)
Time Frame: Day 0 (transplant day)
Assesses coping styles; 28-item, Likert-type.
Day 0 (transplant day)
Brief Coping with Problems Experienced scale (COPE)
Time Frame: Day 14
Assesses coping styles; 28-item, Likert-type.
Day 14
Brief Coping with Problems Experienced scale (COPE)
Time Frame: Day 28
Assesses coping styles; 28-item, Likert-type.
Day 28
Brief Illness Perceptions Questionnaire (IPQ)
Time Frame: Baseline
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Baseline
Brief Illness Perceptions Questionnaire (IPQ)
Time Frame: Day 0 (transplant day)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Day 0 (transplant day)
Brief Illness Perceptions Questionnaire (IPQ)
Time Frame: Day 14
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Day 14
Brief Illness Perceptions Questionnaire (IPQ)
Time Frame: Day 28
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Schröder, PhD, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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