Skip to main content
. 2019 May 20;2019(5):CD012855. doi: 10.1002/14651858.CD012855.pub2

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.
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
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.
Outcomes HAM‐D‐21 mean (end of intervention and follow‐up)
Dropout any
SWLS (end of intervention and follow‐up)
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.