Cognitive behavioral therapy for psychological distress in young people diagnosed with cancer during adolescence
ISRCTN | ISRCTN15975376 |
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DOI | https://doi.org/10.1186/ISRCTN15975376 |
Secondary identifying numbers | U-CARE: MAYA |
- Submission date
- 07/08/2017
- Registration date
- 22/08/2017
- Last edited
- 21/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Young people who are diagnosed with cancer during adolescence may suffer from psychological distress after the end of cancer treatment. Cognitive behavior therapy (CBT) is a talking therapy that is effective for a range of psychological disorders and has been tested for the treatment of depression, anxiety and post-traumatic stress disorder. There are currently few psychological treatments developed specifically to fit the needs of young survivors of cancer and no study has tested individualized CBT specifically tailored to reduce psychological distress in young survivors of cancer diagnosed during adolescence. The aim of this study is therefore to develop and test a CBT-based treatment targeting cancer-related psychological distress experienced by young people who have completed treatment for cancer diagnosed during adolescence.
Who can participate?
Young people aged between 15-25 who have been diagnosed with cancer during adolescence, have completed successful cancer treatment and experience cancer-related suffering
What does the study involve?
Participants are offered up to 15 weekly 45-minute sessions of individual CBT provided by three resident psychologists. Psychological distress is assessed before treatment, at the end of treatment, and at 3 months after the end of treatment.
What are the possible benefits and risks of participating?
By enrolling in this study participants can receive psychological support. There are no anticipated side effects of the treatment. Working with one's mental health problems can involve some distress. Participants who do not experience improvement or who deteriorate during the treatment might have less confidence in psychological treatments in the future. Participants in need of immediate/more intensive/other psychological treatment than can be offered within this study are guided to appropriate healthcare.
Where is the study run from?
Uppsala University Children's Hospital (Sweden)
When is the study starting and how long is it expected to run for?
May 2014 to October 2016
Who is funding the study?
1. Swedish Research Council
2. Swedish Childhood Cancer Foundation
3. Swedish Cancer Society
Who is the main contact?
Prof. Louise von Essen
louise-von.essen@kbh.uu.se
Contact information
Scientific
Uppsala universitet
Uppsala biomedicinska centrum
Institutionen för kvinnors- och barns hälsa
Klinisk psykologi i hälso- och sjukvård
Box 572
Uppsala
75123
Sweden
0000-0001-5816-7231 | |
Phone | +46 (0)184 713 484 |
louise-von.essen@kbh.uu.se |
Study information
Study design | Single-group non-randomised open trial |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Development of psychological treatment for cancer-related suffering experienced by young people diagnosed with cancer during adolescence |
Study objectives | Since there are no evidence-based interventions for young survivors of cancer during adolescence who experience cancer-related suffering, the purpose of the current study was to develop and preliminary evaluate if individual CBT can reduce distress among these survivors. |
Ethics approval(s) | Regional Ethical Review Board in Uppsala, Sweden, 22/12/2014, Dnr: 2014/443 |
Health condition(s) or problem(s) studied | Cancer-related psychological distress |
Intervention | All participants are offered up to 15 weekly 45-minute sessions of individual CBT provided by three resident psychologists under supervision. The CBT interventions are based on a clinical behavior analysis. Psychological distress is assessed before treatment (baseline), at the end of treatment (post-treatment), and 3-months after end of treatment. |
Intervention type | Behavioural |
Primary outcome measure | 1. Anxiety, assessed with the Beck Anxiety Inventory (BAI) at baseline, post-treatment and at 3 months after end of treatment 2. Depression, assessed with the Montgomery Åsberg Depression Rating Scale Self-assessment (MADRS-S) at baseline, post-treatment and at 3 months after end of treatment 3. Post-traumatic stress symptoms, assessed with the The PTSD Checklist - Civilian (PCL-C) at baseline, post-treatment and at 3 months after end of treatment 4. Worry, assessed with the Penn State Worry Questionnaire (PSWQ) at baseline, post-treatment and at 3 months after end of treatment |
Secondary outcome measures | 1. Body dissatisfaction, assessed with the Body Image Scale (BIS) at baseline, post-treatment and at 3 months after end of treatment 2. Experiential avoidance, assessed with the Acceptance and Action Questionnaire (AAQ-II) at baseline, post-treatment and at 3 months after end of treatment 3. Fatigue, assessed with the Fatigue Assessment Scale (FAS) at baseline, post-treatment and at 3 months after end of treatment 4. Functional impairment, assessed with the Sheehan Disability Scale (SDS) at baseline, post-treatment and at 3 months after end of treatment 5. Health anxiety, assessed with the Short Health Anxiety Inventory (SHAI) at baseline, post-treatment and at 3 months after end of treatment 6. Somatic symptoms, assessed with the Patient Health Questionnaire-15 (PHQ-15) at baseline, post-treatment and at 3 months after end of treatment 7. Rumination, assessed with the Rumination Scale of the Response Style Questionnaire (RSQ): at baseline, post-treatment and at 3 months after end of treatment 8. The presence of psychiatric disorders, assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I), a structured diagnostic psychiatric interview for DSM-IV and ICD-10, at baseline, post-treatment and at 3 months after end of treatment |
Overall study start date | 01/05/2014 |
Completion date | 10/10/2016 |
Eligibility
Participant type(s) | Patient |
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Age group | Mixed |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Aged 15-25 years at study start 2. Diagnosed with cancer when aged 13-18 years 3. Treated at a paediatric oncology unit in Sweden 4. Completed successful cancer treatment 5. Experience cancer-related suffering |
Key exclusion criteria | 1. Currently receive psychological treatment 2. Display psychiatric symptoms in immediate need of treatment |
Date of first enrolment | 27/02/2015 |
Date of final enrolment | 03/11/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Uppsala
75185
Sweden
Sponsor information
University/education
Box 256
Uppsala
75105
Sweden
Website | www.uu.se |
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https://ror.org/048a87296 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Childhood Cancer Foundation
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Results and Publications
Intention to publish date | 01/11/2017 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The results from the trial will be published in a doctoral dissertation at Uppsala University and will be submitted for publication in a scientific journal approximately in November 2017. |
IPD sharing plan | Ethical restrictions prohibit making the dataset publicly available. Data are available on request from the research group Clinical Psychology in Healthcare at the Department of Women's and Children's Health, Uppsala University for researchers who meet the criteria for access to confidential data. Requests should be sent to PI Prof. Louise von Essen (louise-von.essen@kbh.uu.se). |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Other publications | Qualitative feasibility results | 17/04/2018 | 21/09/2023 | Yes | No |
Protocol file | 21/09/2023 | No | No |
Additional files
Editorial Notes
21/09/2023: Publication reference and protocol (not peer reviewed) added.
24/05/2019: Internal review.