Szigethy 2007.
| Methods |
Study design: randomised controlled trial Study grouping: parallel group Setting: outpatient clinic Outcome measures: Children’s Depression Inventory (CDI); Children’s Global Assessment Scale (CGAS) completed at baseline and post‐intervention (12‐14 weeks) |
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| Participants |
Type of chronic illness: inflammatory bowel disease Inclusion criteria: CDI score of 9 or greater and/or CDI‐P score of 9 at step 2; aged 11‐17 years; biopsy‐confirmed inflammatory bowel disorder Exclusion criteria: unable to speak English; current mood disorder or psychotic disorder; antidepressant medication within two weeks of assessment; substance use/dependence within one month of study enrolment; suicide attempt within one month of study enrolment; previous depression requiring hospitalisation; failure of previous manualised CBT of at least 8 sessions Baseline characteristics Overall Number: 40 Sex (males (%)): 20 (48.8%) Age in years (SD): 14.99 (2.01) Severity of chronic illness: not reported Ethnicities: 31 (78.1%) white; 6 (14.6%) African‐American; 1 (2.4%) Latina; 2 (4.9%) other Depressive symptoms – rating (SD): not reported Cognitive behavioural therapy (PASCET‐PI) Number: 21 Sex (males (%)): 12 (54%) Age in years (SD): 14.95 (2.33) Type of chronic illness: inflammatory bowel disease Severity of chronic illness: 50.0% on steroids Ethnicities: 19 (90.9%) white, 2 (9.1%) African‐American Depressive symptoms – rating (SD): CDI = 25.7 (10.8) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): moderate Treatment‐as‐usual + information sheet Number: 19 Sex (males (%)): 10 (52.5%) Age in years (SD): 15.02 (1.83) Type of chronic illness: inflammatory bowel disease Severity of chronic illness: 42.9% on steroids Ethnicities: 15 (79.9%) white, 4 (29.4%) African‐American Depressive symptoms – rating (SD): CDI = 21.8 (8.1) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): moderate Baseline differences: no significant differences |
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| Interventions |
Intervention characteristics Cognitive behaviour therapy (PASCET‐PI) Audience: child and parent Description of intervention: targets depression, and skill development to improve cognitions and behaviours related to IBD. Uses the physical illness narrative to address cognitive distortions; relaxation and guided imagery for pain; and behavioural motivation Modality: individual Dose: 9‐11 60 min sessions (up to 3 delivered via telephone) Manualised or non‐manualised: manualised Parent or caregiver involvement: three independent parent sessions designed to educate parents about IBD and MDD, as well as teaching them to become CBT coaches Therapist involvement: delivery of sessions Treatment‐as‐usual + information sheet Audience: child Description of intervention: treatment‐as‐usual (not described) plus the provision of an information sheet for parents about depression Modality: individual Manualised or non‐manualised: non‐manualised |
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| Outcomes | Specific depression measures: Children`s Depression Inventory (CDI) | |
| Identification |
Sponsorship source: National Institute Mental Health, Wolpow Family Fund Country: USA Authors name: Eva Szigethy Institution: University of Pittsburgh Medical Center Email: szigethye@upmc.edu. Address: Children’s Hospital of Pittsburgh3705 Fifth AvenueRoom 2423, DeSoto WingPittsburgh, PA 15213 |
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| Notes | Therapy designed to address depression | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Judgement comment: randomisation not clearly described |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: allocation concealment not clearly described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: blinding of participants not clearly described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: outcome assessors were blinded to the treatment group of participants |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: three participants discontinued the intervention. Management of missing data not clearly described. |
| Selective reporting (reporting bias) | Low risk | Judgement comment: all planned outcomes reported |
| Other bias | Low risk | Judgement comment: no other biases identified |