Agras 2014.
Methods | RCT | |
Participants | Country: USA
Diagnostic tool: DSM‐IV except for the amenorrhoea criterion and with up to 87% of their IBW
No. screened: 564
No. randomised: Total: 164; FBT: 82; SyFT 82
No. started trial: FBT 78; SyFT 80
No. dropped out during intervention: Total: 40; FBT: 20; SyFT 20
No. dropped out during follow‐up: No detail
No. analysed (observed case): Total: 158; FBT: 78; SyTF 80 Mean age in years (SD): Total: 15.3 (1.8); FBT: 15.1 (1.7), SyFT: 15.6 (1.8) Age range in years: Total: Between ages 12 ‐18 Gender %: Total female 89.2%; FBT 85.9%; SyTF 92.5% Subtype purging %: No detail Subtype restricting %: No detail Age of onset: No detail Duration of illness: Total 13.5 (13.9) moths; FBT:11.6 (9.8); SyFT:15.4 (16.9) Baseline weight: Total: mean IBW 81.9%; FBT: 82.2% (3.8); SyFT: 81.7% (3.7) Baseline BMI: No detail Baseline eating disorder scale score: Total: No detail; FBT: 1.6 (1.3) EDE; SyFT: 1.9 (1.5) EDE Baseline eating disorder scale score: Total: No detail; FBT: 10.7 (8.0) Yale‐Brown‐Cornell Eating Disorder Scale; SyFT: 12.1 (8.4) Yale‐Brown‐Cornell Eating Disorder Scale Comorbidity: Total: Dep ‐ 25.3%, Anx ‐ 10.8%, OCD ‐ 11.4 %, Other ‐ 10.1%; FBT: Dep ‐ 25.6%, Anx ‐ 14.1%, OCD ‐ 10.2%, Other ‐ 9.0%; SyFT: Dep ‐ 25.0%, Anx ‐ 7.5%, OCD ‐ 12.5 %, Other ‐ 11.2% Details on living arrangements: No detail Family education/employment/income: No detail Recruitment strategy: 6 clinical sites experienced in the treatment of AN, 1 site had difficulty with recruitment and was replaced by another site Exclusion criteria:
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Interventions | Setting of care: Outpatient
Training/qualification of care provider(s): Yes: 26 therapists were doctorate‐ or masters‐level psychologists, psychiatrists, or social workers; mean of 6 years’ experience in the treatment of adolescent AN
Treatment manual: Yes, both treatments
Supervision of treatment: Therapists were trained in separate workshops for each treatment and then completed treatment for 2 cases with supervision from experts in each type of family therapy (JL for FBT and ED for SyFT). Supervision of therapists continued at weekly intervals throughout the treatment phase and were provided centrally by the data and co‐ordinating centre and at the site level by a trained supervisor, with each treatment supervised separately. Elements of supervision included listening to therapy tapes, case discussions focusing on the process of treatment, behavioural rehearsal, and treatment planning
Adherence to treatment: Yes: Fidelity to each treatment was assessed at 1 of the sites by 6 raters with a graduate degree in psychology or social work and experience in treating eating disorders. Raters were trained in 1 of the 2 treatments by reading the manual and viewing tapes of the training workshop for clinicians and were also trained in the application of the appropriate fidelity instrument for which reliability was established. Each site provided 4 videotapes per family randomly sampled from each of the following blocks of sessions: 1 to 4, 5 to 8, 9 to 12, and 13 to 16. A total of 421 therapy tapes were audited (210 FBT and 211 SyFT). The overall mean scores for fidelity were FBT 4.15 (0.94) and SyFT 4.38 (0.48) on a 0 to 6 scale
Intervention group 1
Description: Family‐based therapy Length: 60 min, 16 sessions over 9 months Intervention group 2 Description: Systemic family therapy There is no family meal or specific emphasis on normalisation of eating or weight, although if the family raises this issue, the therapist will help them address it Length: 60 min, 16 sessions over 9 months |
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Outcomes |
Eating psychopathology EDE Yale‐Brown‐Cornell EDS Behavioural indices Remission (defined as achieving a minimum of 95% of the IBW) Ideal body weight % (IBW) General psychopathology and obsessionality BDI STAI Child Yale‐Brown Obsessive Compulsive Scale Rosenberg self‐esteem scale Global pathology and interpersonal functioning Quality of Life and Enjoyment Scale (short form) |
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Notes | The study was supported in part by the following grants from the National Instituteof Mental Health: 1UO1 MH076290 (Dr Agras), MH076254 (Dr Brandt), MH 076251 (Dr Halmi), MH076250 (Dr Johnson), MH 076255 (Dr Wilfley), and076252 (Dr Woodside). Standard deviations often not reported so data for eating disorder psychopathology and weight could not be used |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised within sites to 1 of the 2 family therapies using a computer‐generated programme |
Allocation concealment (selection bias) | Unclear risk | No detail |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Therapists and participants cannot be blinded in trials of family‐based therapy |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors were blinded to the treatment condition |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Results for all participants who began treatment reported |
Selective reporting (reporting bias) | Unclear risk | All measures appear to have been reported on; but in many cases the SDs were not reported |
Other bias | Unclear risk |
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