Hellerstein 2001.
Methods | Design: RCT Phases: acute (8 weeks), continuation (16 weeks) Comparison groups: fluoxetine vs fluoxetine + group psychotherapy Funded by: grant from Eli Lilly Company. |
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Participants | Number of participants randomized (NRCT: number of participants included): 40 Criteria for relapse/recurrence: not available Age distribution in sample (mean): 45.1 (SD 9.8) years Sex distribution in sample (% women): 50 Diagnoses in sample: 100% dysthymia Depression severity at continuation/maintenance baseline (mean): HAM‐D 21: fluoxetine: 7.8 (SD 4.7); combination: 6.2 (SD 4.9) Age of onset: unclear Length current/last major episode in months: unclear |
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Interventions | Continuation treatment (16 weeks) Fluoxetine (participants = 18) Name (class and type): fluoxetine (SSRI) Planned dosage of drug: 20–80 mg/day Dosage of drug (mean): 38.8 (SD 18.9) mg/day Combination (participants = 19) Name (class and type): fluoxetine (SSRI) + group psychotherapy (CT/IPT) Planned number of sessions + dosage of drug: 16 sessions + 20–80 mg/day Dosage of drug (mean): 37.4 (SD 17.3) mg/day Notes: participants were not allowed to currently undergo another psychotherapy. In the medication group, psychiatrists were instructed not to engage in psychotherapy, counselling, or supportive interventions. |
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Outcomes | HAM‐D‐21 mean (end of intervention and follow‐up) Dropout any SWLS (end of intervention and follow‐up) |
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Notes | Possibly conflict of interest (funded by Eli Lilly); discrepant information given in text vs tables; sometimes also unclear/discrepant: information given in text itself; treatment/group therapy = CIGP‐CD manual, which is not classified by Cochrane. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Psychotherapy trial, no blinding possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Unblinded raters" (p. 101) |
Incomplete outcome data (attrition bias) All outcomes | High risk | LOCF method for physician rated scales: 7/35 (20%) dropout at follow‐up (36 weeks), these scales are main outcomes; no comment why participants dropped out. |
Selective reporting (reporting bias) | Unclear risk | No existing study protocol. |
Other bias | High risk | Quote: "Insufficient treatment adherence: Sessions were audiotaped and reviewed in weekly supervision meetings for adherence to the manual." (pp. 96–7) Allegiance bias/conflict of interest: financed by pharmaceutical company, but unclear/no further information. Attention bias: more attention in the combination group as this group also received psychotherapy. Other: very likely that randomization was before acute treatment, but it was not described clearly. Discrepant information in the text. |