- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02212236
Psychological Intervention for Distress During HSCT
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Schröder, PhD, University of Nottingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14069
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.
Clinical Trials on Psychological Distress
-
Utah State UniversityNot yet recruitingPsychological Distress | Psychological Flexibility | Psychological Well-BeingUnited States
-
Gunther MeinlschmidtRecruitingPsychological DistressGermany
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
University of WaterlooRecruitingPsychological DistressCanada
-
Dokuz Eylul UniversityActive, not recruitingPsychological DistressTurkey
-
VA Eastern Colorado Health Care SystemUniversity of Colorado, Denver; Military Suicide Research ConsortiumCompletedPsychological DistressUnited States
-
University of ZurichFreie Universität BerlinTerminatedPsychological DistressSwitzerland, Germany
-
Combat StressRoyal British LegionCompletedPsychological DistressUnited Kingdom
-
Norwegian Knowledge Centre for the Health ServicesUniversity of Oslo; University of Tromso; Norwegian Medical AssociationUnknown
-
Fondation Santé des Étudiants de FranceRecruitingPsychological DistressFrance
Clinical Trials on Psychological preparation
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedObesity | Psychological DisordersUnited Kingdom
-
The Affiliated Hospital of Qingdao UniversityEnrolling by invitationPharmacokinetics | SafetyChina
-
Università Vita-Salute San RaffaeleUnknownDental Prosthesis Failure | Tissue Injury | Dental Prosthesis Complication | Prosthetic Tissue DefectItaly
-
Centre Hospitalier Universitaire de BesanconUnknownPrimary Headache DisorderFrance
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingBlood Pressure | Psychological StressUnited States
-
Guangxi Medical UniversityCompletedBurnout | PsychologicalChina
-
Alexandria UniversityCompletedPsychological Distress | ResilienceEgypt
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknown
-
The Affiliated Hospital of Qingdao UniversityChangzhou Pharmaceutical Factory Co., LtdNot yet recruitingPharmacokinetics | Safety
-
University of Padova, School of Dental MedicineCompletedGingival Recession | Gingival Bleeding | Gingival DiseaseItaly