Cognitive behavioral therapy for psychological distress in young people diagnosed with cancer during adolescence

• Register: ISRCTN
• Last refreshed on: 3 October 2023
• Main ID: ISRCTN15975376
• Date of registration: 22/08/2017
• Prospective Registration: No
• Primary sponsor: Uppsala University
• Public title: Cognitive behavioral therapy for psychological distress in young people diagnosed with cancer during adolescence
• Scientific title: Development of psychological treatment for cancer-related suffering experienced by young people diagnosed with cancer during adolescence
• Date of first enrolment: 27/02/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15975376
• Study type: Interventional
• Study design: Single-group non-randomised open trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Louise von Essen

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Currently receive psychological treatment
2. Display psychiatric symptoms in immediate need of treatment

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer-related psychological distress
Mental and Behavioural Disorders

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

U-CARE: MAYA

Source(s) of Monetary Support

Vetenskapsrådet, Barncancerfonden, Cancerfonden

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regional Ethical Review Board in Uppsala, Sweden, 22/12/2014, Dnr: 2014/443

Results

• Results available: Yes
• Date Completed: 10/10/2016