Cognitive behavior therapy for psychological distress in parents of childhood cancer survivors
| ISRCTN | ISRCTN74785895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74785895 |
| Secondary identifying numbers | Petra |
- Submission date
- 06/03/2017
- Registration date
- 08/03/2017
- Last edited
- 14/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Childhood cancer care has improved dramatically over the past 20 years and the overall survival rate for childhood cancer is now approaching 80 %. Advances in treatments have ensured this development and children struck by cancer experience increasing periods of disease-free survival. Although most children diagnosed with cancer survive the disease, challenges remain for these children and their families. A growing body of research has shed light on the long-term physical and psychological consequences of cancer and it has been shown that childhood cancer survivors and their parents are at risk for psychological problems. Cognitive behavior therapy (CBT) is effective for a range of psychological disorders and has been tested for the treatment of depression, anxiety and post-traumatic stress disorder. To date, no study has tested CBT tailored to psychological distress in parents of childhood cancer survivors. The aim of this study is therefore to find out whether individualized face-to-face CBT can reduce distress in parents of children previously treated for cancer.
Who can participate?
Parents of childhood cancer survivors who experience suffering related to their child’s cancer, 3 months to 5 years after the end of the child´s treatment for cancer.
What does the study involve?
Participating parents are offered 10-15 weekly 45-minute sessions of individual CBT. Psychological distress (post-traumatic stress, depression, anxiety) is assessed before treatment, at the end of treatment, and at 3 months follow-up.
What are the possible benefits and risks of participating?
Possible benefits include reductions in distress as similar treatments have been shown to be effective. Regarding possible risks, participants might experience increased distress at the start of the treatment as they may be reminded about distressing events. Participants who do not experience improvement or who deteriorate during the treatment might have less confidence in psychological treatments in the future.
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?
March 2012 to December 2015
Who is funding the study?
1. Swedish Research Council
2. Swedish Cancer Society
Who is the main contact?
Dr Martin Cernvall
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
 ORCID ID |
0000-0002-7237-4429 |
|---|
Study information
| Study design | Single-group non-randomised open trial |
|---|---|
| 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 and preliminary evaluation of Individualized face-to-face cognitive behavior therapy for psychological distress in parents of childhood cancer survivors |
| Study objectives | Since there are no evidenced-based interventions for parents of childhood cancer survivors who experience suffering related to their child's illness, the purpose of the current study was to develop and preliminary evaluate if individual CBT can reduce distress among these parents. |
| Ethics approval(s) | Regional Ethics Committee of Uppsala, 17/12/2012, Dnr: 2012/440 |
| Health condition(s) or problem(s) studied | Psychological distress (posttraumatic stress, depression, anxiety) |
| Intervention | Included parents are offered 10-15 weekly 45-minute sessions of individual CBT provided by two resident psychologists under supervision. Psychological distress (post-traumatic stress, depression, anxiety) is assessed before treatment, at the end of treatment, and at 3-months follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. 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 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. Anxiety, assessed with the Beck Anxiety Inventory (BAI) at baseline, post-treatment and at 3 months after end of treatment |
| Secondary outcome measures | 1. Experiential avoidance, assessed with the Acceptance and Action Questionnaire (AAQ-II) at baseline, post-treatment and at 3 months after end of treatment 2. Worry, assessed with the Penn State Worry Questionnaire (PSWQ) at baseline, post-treatment and at 3 months after end of treatment 3. Rumination, assessed with the Rumination Scale of the Response Style Questionnaire (RSQ) at baseline, post-treatment and at 3 months after end of treatment 4. Perceived quality of life, assessed with the Satisfaction with Life Scale (SWLS) at baseline, post-treatment and at 3 months after end of treatment 5. 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 | 01/03/2012 |
| Completion date | 04/12/2015 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Parents of children who have finished a successful cancer treatment 3 months to 5 years previously 2. Who experience suffering that they relate to the child's disease 3. Swedish speaking 4. Live relatively close to Uppsala, Västerås or Gävle |
| Key exclusion criteria | 1. Suffer from a psychiatric disorder in immediate need of treatment 2. In psychotherapy 3. If they have suicidal ideations |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 15/02/2014 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Uppsala
75185
Sweden
Sponsor information
University/education
Department of Public Health and Caring Sciences
Box 265
Uppsala
75105
Sweden
"ROR" |
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 Cancer Society
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/06/2017 |
|---|---|
| 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 high impact journal approximately 12 months after the last data-collection. |
| IPD sharing plan | Ethical restrictions prohibit making the dataset publicly available. The ethical approval obtained ensures use of the dataset to answer the already stipulated research questions and to ensure that the data are processed in accordance with the Swedish Personal Data Act (Swedish: Personuppgiftslagen; 1998:204). Data are available at request from the research group Clinical Psychology in Healthcare at the Department of Public Health Care Sciences, Uppsala University for researchers who meet the criteria for access to confidential data. Requests should be sent to PI Prof. Louise von Essen. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/04/2018 | 14/05/2019 | Yes | No |
Editorial Notes
14/05/2019: Publication reference and total final enrolment added.
