Psychological DistressPhase 2NCT02212236
Psychological Intervention for Distress During HSCT
A Phase 2 study testing Psychological preparation in people with Psychological Distress and Haematopoietic Stem Cell Transplantation, run by University of Nottingham at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Haematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
- What is being tested?
- Psychological preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Consent withdrawn
- Consultant Haematologist raises concern regarding participation
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: 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.
Read more
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.
- Conditions
- Psychological Distress, Haematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
- Being tested
- Psychological preparation
- Keywords
- Distress, Depression, Anxiety, Stress, Coping, Illness perceptions, Stem cell transplantation, Bone marrow transplantation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological preparationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychological preparation + TAU | Experimental | TAU=treatment as usual Receives: Other: Psychological preparation |
| Treatment as usual | No intervention | Usual care including medication, nursing, and psychologist support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Measured: Baseline
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Measured: Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Measured: Day 14
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Measured: Day 28
Secondary outcomes (12)
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Measured: Baseline
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Measured: Day 0 (transplant day)
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Measured: Day 14
Brief Resilience Scale (BRS)
Assesses resilience; 6 items, Likert-type.
Measured: Day 28
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Measured: Baseline
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Measured: Day 0 (transplant day)
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Measured: Day 14
Brief Coping with Problems Experienced scale (COPE)
Assesses coping styles; 28-item, Likert-type.
Measured: Day 28
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Measured: Baseline
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Measured: Day 0 (transplant day)
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Measured: Day 14
Brief Illness Perceptions Questionnaire (IPQ)
Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Thomas Schröder, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212236
- Sponsor's protocol ID
- 14069
- Status last verified
- Oct 2015
- First submitted
- 4 Aug 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
- ClinicalTrials.gov ID
- NCT02212236
- Acronym / sponsor ID
- 14069
- Conditions
- Psychological Distress, Haematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
- Keywords
- Distress, Depression, Anxiety, Stress, Coping, Illness perceptions, Stem cell transplantation, Bone marrow transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological preparation + TAU | Experimental | Other: Psychological preparationTAU=treatment as usual |
| Treatment as usual | No intervention | –Usual care including medication, nursing, and psychologist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Consent withdrawn
- Consultant Haematologist raises concern regarding participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological preparationNinety-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. | Other | Psychological preparation + TAU |
Primary outcome
Depression Anxiety Stress Scales (DASS-21)
Time frame: Baseline
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
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.
Depression Anxiety Stress Scales (DASS-21)
Time frame: Day 14
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Depression Anxiety Stress Scales (DASS-21)
Time frame: Day 28
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
12 secondary outcomes
Brief Resilience Scale (BRS)
Time frame: Baseline
Brief Resilience Scale (BRS)
Time frame: Day 0 (transplant day)
Brief Resilience Scale (BRS)
Time frame: Day 14
Brief Resilience Scale (BRS)
Time frame: Day 28
Brief Coping with Problems Experienced scale (COPE)
Time frame: Baseline
Brief Coping with Problems Experienced scale (COPE)
Time frame: Day 0 (transplant day)
Brief Coping with Problems Experienced scale (COPE)
Time frame: Day 14
Brief Coping with Problems Experienced scale (COPE)
Time frame: Day 28
Brief Illness Perceptions Questionnaire (IPQ)
Time frame: Baseline
Brief Illness Perceptions Questionnaire (IPQ)
Time frame: Day 0 (transplant day)
Brief Illness Perceptions Questionnaire (IPQ)
Time frame: Day 14
Brief Illness Perceptions Questionnaire (IPQ)
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Related trials for Psychological Distress
RecruitingPhase 2
Duloxetine in Inflammatory Bowel Diseases
Inflammatory Bowel Diseases
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schröder, PhD principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychological preparation in people with Psychological Distress and Haematopoietic Stem Cell Transplantation, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scales (DASS-21) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.