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Completed

NCT Number: NCT02212236

Psychological Intervention for Distress During HSCT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nottingham City Hospital, Nottingham, Nottinghamshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological preparation

Other

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.

Primary outcomes

  1. Depression Anxiety Stress Scales (DASS-21)

    Time frame: Baseline

    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

  2. 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.

  3. Depression Anxiety Stress Scales (DASS-21)

    Time frame: Day 14

    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

  4. Depression Anxiety Stress Scales (DASS-21)

    Time frame: Day 28

    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

Secondary outcomes

  1. Brief Resilience Scale (BRS)

    Time frame: Baseline

    Assesses resilience; 6 items, Likert-type.

  2. Brief Resilience Scale (BRS)

    Time frame: Day 0 (transplant day)

    Assesses resilience; 6 items, Likert-type.

  3. Brief Resilience Scale (BRS)

    Time frame: Day 14

    Assesses resilience; 6 items, Likert-type.

  4. Brief Resilience Scale (BRS)

    Time frame: Day 28

    Assesses resilience; 6 items, Likert-type.

  5. Brief Coping with Problems Experienced scale (COPE)

    Time frame: Baseline

    Assesses coping styles; 28-item, Likert-type.

  6. Brief Coping with Problems Experienced scale (COPE)

    Time frame: Day 0 (transplant day)

    Assesses coping styles; 28-item, Likert-type.

  7. Brief Coping with Problems Experienced scale (COPE)

    Time frame: Day 14

    Assesses coping styles; 28-item, Likert-type.

  8. Brief Coping with Problems Experienced scale (COPE)

    Time frame: Day 28

    Assesses coping styles; 28-item, Likert-type.

  9. Brief Illness Perceptions Questionnaire (IPQ)

    Time frame: Baseline

    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  10. Brief Illness Perceptions Questionnaire (IPQ)

    Time frame: Day 0 (transplant day)

    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  11. Brief Illness Perceptions Questionnaire (IPQ)

    Time frame: Day 14

    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  12. Brief Illness Perceptions Questionnaire (IPQ)

    Time frame: Day 28

    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Nottingham University Hospitals NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2014
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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