Szigethy 2014.

Methods	Study design: randomised controlled trial Study grouping: parallel group Setting: outpatient clinic at two children's hospitals Outcome measures: Children’s Depression Rating Scale (CDRS‐R) Pediatric’s Chrons Disease Activity Index (PCDAI); Pediatric Ulcerative Colitis Activity Index (PUCAI) completed at baseline and post‐intervention (3 months)
Participants	Type of chronic illness: gastrointestinal problems Inclusion criteria: 9‐17 years; identified as having IBS by the Porto Criteria; diagnosis of major or minor depression as defined by the DSM‐IV‐TR or the KSADS‐PL Exclusion criteria: lifetime episode of psychotic or bipolar disorder or eating disorder requiring hospitalisation; suicide attempt within one month of the assessment; hospitalisation for MDD within three months of assessment; use of antidepressants within one month of assessment; substance use by history; iatrogenic opiate use within one month of assessment; current psychotherapy engagement Baseline characteristics Overall Number: 217 Sex (males (%)): 102 (47.2%) Age in years (SD): 14.3 Type of chronic illness: 161 (74%) Crohn's disease, 56 (26%) ulcerative colitis Severity of chronic illness: not reported Ethnicities: mixed Depressive symptoms – rating (SD): not reported Cognitive behaviour therapy Number: 110 Sex (males (%)): 54 (49.1%) Age in years (SD): 14.3 (2.5) Type of chronic illness: 79 (72%) Crohn's, 27 (28%) ulcerative colitis Severity of chronic illness: PCDAI (Crohn's) 21.0 (SD:16.2), PUCAI (UC) 23.3 (SD: 24.9) Ethnicities: 104 (94.6%) white, 6 (5.4%) other Depressive symptoms – rating (SD): CDRS‐R 45.1 (12.1) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): mild Supported nondirective therapy Number: 107 Sex (males (%)): 48 (44.9%) Age in years (SD): 14.3 (2.3) Type of chronic illness: 74 (69%) Crohn's, 26 (31%) ulcerative colitis Severity of chronic illness: PDCAI (Crohn's) 22.4 (SD: 16.9), PUCAI 25.8 (SD: 23.8) Ethnicities: 90 (84.1%) white, 17 (15.9%) other Depressive symptoms – rating (SD): CDRS‐R 48.9 (12.8) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): mild Baseline differences: Ethnicity (CBT 94.6%, SNDT 84.1%), surgical resection rate (CBT 5.6%, SNDT 14.2%), and raw mean baseline CDRSR scores (CBT 45.1, SNDT 48.9).
Interventions	Intervention characteristics Cognitive behaviour therapy Audience ‐ child / child and parent: child and parent Description of intervention: CBT modules delivered either face‐to‐face or over the telephone. Topics included behavioural activation, relaxation strategies, challenging negative thinking, and relapse prevention. In addition to this, there were 3 parent sessions. Modality: child and family Dose: up to 12 sessions of 45 minutes over three months (9 key sessions with 3 sessions of flexible content) + 3 parent sessions Manualised or non‐manualised: manualised Parent or caregiver involvement: 3 individual sessions Therapist involvement: delivery of sessions Supported nondirective therapy Audience: child and parent Description of intervention: supportive psychotherapy where children were encouraged to talk about whatever was bothering them. In addition to this, there were 3 parent sessions. Modality: individual (child and family) Dose: 12 sessions of 45‐minute duration over three months + 3 parent sessions Manualised or non‐manualised: non‐manualised Parent or caregiver involvement: 3 individual sessions Therapist involvement: delivery of sessions
Outcomes	Specific depression measures: Children’s Depression Inventory (CDI) Quality of life: IMPACT‐III Questionnaire Status of long‐term physical condition: Pediatric Chrons Diease Activity Index (PCDAI) or Pediatric Ulcerative Colitis Activity Index (PUCAI) ‐ no data included in meta‐analysis
Identification	Sponsorship source: the National Institute of Mental Health (NIMH) through grants R01 MH077770 and NCT00534911. Country: United States of America Authors name: Eva Szigethy Institution: Children's Hospital of Pittsburgh Email: szigethye@upmc.edu Address: Children’s Hospital of Pittsburgh, 4401 Penn Avenue, 3rd Floor Plaza Building, Pittsburgh, PA 15224
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Judgement comment: block randomisation used, but mechanism (computerised/manual) not described
Allocation concealment (selection bias)	Unclear risk	Judgement comment: not clearly described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Judgement comment: not clearly described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Judgement comment: self‐report by participants
Incomplete outcome data (attrition bias) All outcomes	Low risk	Judgement comment: included all participants in the analysis including those that dropped out
Selective reporting (reporting bias)	High risk	Judgement comment: only some data presented. Post‐intervention data regarding depression and symptoms of IBD (and SDs) not reported.
Other bias	High risk	Judgement comment: some of the study authors were the developers of the intervention