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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 27 May 2019
Main ID:  ISRCTN74785895
Date of registration: 08/03/2017
Prospective Registration: No
Primary sponsor: Uppsala University
Public title: Cognitive behavior therapy for psychological distress in parents of childhood cancer survivors
Scientific title: Development and preliminary evaluation of Individualized face-to-face cognitive behavior therapy for psychological distress in parents of childhood cancer survivors
Date of first enrolment: 01/02/2013
Target sample size: 20
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN74785895
Study type:  Interventional
Study design:  Single-group non-randomised open trial (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Sweden
Contacts
Name: Martin    Cernvall
Address:  Uppsala universitet Uppsala biomedicinska centrum Institutionen för kvinnors och barns hälsa Klinisk psykologi i hälso- och sjukvård Box 572 75123 Uppsala Sweden
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
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Key inclusion & exclusion criteria
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

Exclusion criteria:
1. Suffer from a psychiatric disorder in immediate need of treatment
2. In psychotherapy
3. If they have suicidal ideations


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Psychological distress (posttraumatic stress, depression, anxiety)
Mental and Behavioural Disorders
Intervention(s)
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.
Primary Outcome(s)

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(s)

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
Secondary ID(s)
Petra
Source(s) of Monetary Support
Vetenskapsrådet, Cancerfonden
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Regional Ethics Committee of Uppsala, 17/12/2012, Dnr: 2012/440
Results
Results available: Yes
Date Posted:
Date Completed: 04/12/2015
URL:
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