Posttraumatic stress, depression, anxiety Mental and Behavioural Disorders
Conditions
Interventions
ENGAGE can be described as an internet-administered, guided, cognitive-behavioral therapy (CBT) based, self-help intervention. All participants will receive the intervention. The intervention is guide
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parents/caregivers (adults, both mothers and fathers) will be included according to: 1. Parent of a child diagnosed with cancer when 0-18 years who has completed cancer treatment 3 months to 5 years previously 2. Resides in Sweden 3. Able to read and understand text in Swedish 4. Has access to e-mail, the internet, and a mobile telephone and/or Bank ID 5. Self-reports a need for psychological support related to the child’s cancer disease and treatment
Exclusion criteria
Exclusion criteria: 1. Self-reported or clinician-assessed (based on the M.I.N.I neuropsychiatric interview) symptoms of a severe and enduring mental health difficulty 2. Self-reported or clinician-assessed (based on the M.I.N.I neuropsychiatric interview) misuse of alcohol, street drugs, and/or prescription medication 3. Acutely suicidal 4. Currently attending psychological treatment. Those excluded due to a severe and enduring mental health difficulty, substance misuse, and/or acute suicidality will be guided to appropriate healthcare services
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment and eligibility is assessed by: 1. Number of parents identified via the Swedish Childhood Cancer Registry and the Swedish Tax Agency and/or via advertisements at the end of the 6 month recruitment period 2. Percentage of parents assessed for eligibility; fulfilling inclusion criteria, and included (of total number identified) at the end of the 6 month recruitment period 3. Ambiguities regarding eligibility criteria throughout the 6 month recruitment period 4. Reasons for ineligibility throughout the 6 month recruitment period 5. Reasons for non-participation throughout the 6 month recruitment period Data collection is assessed by: 1. Percentage of participants completing questionnaires at baseline, post-treatment (12 weeks) and 6 month follow-up 2. Numbers of missing items on each clinical outcome measurement at baseline, post-treatment (12 weeks) and 6 month follow-up 3. Types and number of potential uncertainties in diagnostic interviews at baseline Attrition is assessed by: 1. Rates of study dropout at post-treatment (12 weeks) and 6 month follow-up 2. Rate of intervention dropout at post-treatment (12 weeks) Resources needed to complete the study and the intervention is assessed by: Length of time required for: 1. participants to work through the intervention at post-treatment (12 weeks) 2. participants to complete questionnaires and interviews at baseline, post-treatment (12 weeks) and 6 month follow-up 3. e-therapists to deliver the intervention at post-treatment (12 weeks) 4. study personnel to administer the study, assessed at the end of the feasibility trial Participants’ adherence to intervention is assessed by: Number of: 1. opened introductory chapters at post-treatment (12 weeks) 2. opened CBT modules, completed action plans at post-treatment (12 weeks) 3. completed video or telephone assessment sessions at post-treatment (12 weeks) 4. completed ‘booster’ support sessions at post-treatment (12 weeks) P | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of post-traumatic stress (PTSS) is measured using the revised Post traumatic Stress Disorder Checklist for DSM-5 (PCL-5) and DSM-IV (PCL-C) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up. 2. Symptoms of depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, post-treatment (12 weeks) and 6 month follow-up. 3.Symptoms of anxiety is measured using GAD-7 at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up. 4. Frequency of parental fear of cancer recurrence and of their child experiencing another serious health condition is measured using 5 item Likert scales developed by the research team and rated from ”very often” to ”not at all” at baseline, post-treatment (12 weeks) and 6 month follow-up. 5. Psychological inflexibility and experiential avoidance is measured using the Acceptance and Action Questionnaire, 6-items (AAQ-6) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up. 6. Depressive inactivity is measured using the Behavioural Activation for Depression Scale (BADS) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up. 7. Symptoms of fatigue is measured using the Fatigue Severity Scale (FSS) at baseline, post-treatment (12 weeks) and 6 month follow-up. 8. Self-compassion is measured using the Self-Compassion Scale-Short form (SCS-SF) at baseline, post-treatment (12 weeks) and 6 month follow-up. 9. Quality of life is measured using the EQ-5D and with a modified short-version of the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TiC-P), assessing direct and indirect medical costs and indirect non-medical costs at baseline, post-treatment (12 weeks) and 6 month follow-up. 10. Psychiatric disorders is measured using the M.I.N.I neuropsychiatric interview at eligibility interview, post-treatment (12 weeks) and 6 month follow-up | — |
Countries
Sweden
Outcome results
None listed