Main
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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:
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ISRCTN |
Last refreshed on:
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27 May 2019 |
Main ID: |
ISRCTN74785895 |
Date of registration:
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08/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Cognitive behavior therapy for psychological distress in parents of childhood cancer survivors
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Scientific title:
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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:
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01/02/2013 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN74785895 |
Study type:
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Interventional |
Study design:
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Single-group non-randomised open trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Martin
Cernvall |
Address:
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Uppsala universitet
Uppsala biomedicinska centrum
Institutionen för kvinnors och barns hälsa
Klinisk psykologi i hälso- och sjukvård
Box 572
75123
Uppsala
Sweden |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Psychological distress (posttraumatic stress, depression, anxiety) Mental and Behavioural Disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Vetenskapsrådet, Cancerfonden
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Ethics review
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Status:
Approval date:
Contact:
Regional Ethics Committee of Uppsala, 17/12/2012, Dnr: 2012/440
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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04/12/2015 |
URL:
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