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. 2016 Aug 9;2016(8):CD003380. doi: 10.1002/14651858.CD003380.pub4

Reynolds 2011.

Methods Design: cluster‐RCT
Conducted by the team who developed the intervention: yes
Participants Description: universal
Cut‐point for inclusion for indicated studies: N/A
What risk was basis of inclusion for selected studies:  N/A
Diagnostic interview to exclude those with current or previous depression: not undertaken
Baseline severity of depression: DASS‐d: 5.0 (subthreshold)
 
Mean age: 17.9
Age range: not specified
Percentage male: 45.7%
Setting: college
 
State what psychiatric diagnoses were excluded: exclusion criteria not specified
Suicide risk excluded: exclusion criteria not specified
Parents with history of schizophrenia/bipolar disorder excluded: exclusion criteria not specified
 
Country: USA
Interventions Broad category: BT (for further information on intervention components, see Table 3)
Manualised: yes
Online: no
Name of programme: Brief Behavioral Activation Treatment for Depression (BATD)
Number of sessions: 15 sessions
Length of sessions: 120 minutes
Intensity (total number of hours): 30 hours
Duration of treatment period: 15 weeks
Group size: unclear
Delivered by: mental health experts
Fidelity: not assessed
Type of comparison: TAU comprising classes to facilitate student adjustment, including: academic skills, career exploration, library resources, campus safety, sexuality, diversity and responsible decision making. Students were encouraged to make contact with a faculty advisor and to keep diaries reflecting on the process of adjusting to college life.
Outcomes Diagnosis: N/A
Name of self‐report depression measure: DASS‐d
Name of clinical report depression measure: N/A
Name of anxiety measure: N/A
Name of general functioning measure: N/A
Assessment points: post‐intervention
Notes Author contacted for methodological detail: no
Author contacted for treatment manual: yes (provided)
Author contacted for outcome data: no
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information specified
Allocation concealment (selection bias) Unclear risk No information specified
Blinding (performance bias and detection bias) 
 Subjects High risk The nature of the trial suggests it is unlikely participants could have been blind to the fact they were allocated to treatment as usual. However, without access to the participant information sheets and PLS, level of blinding cannot be ascertained.
Blinding (performance bias and detection bias) 
 Assessors Unclear risk "Research assistants were not affiliated in any way with the courses...Research assistants were blind to the class condition as well as the study hypotheses" (p.557).
However, primary outcomes self‐reported. Assessor blinding therefore not applicable.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Proportion of participants with incomplete post‐intervention self‐reported depression scores: 9.6%
Means and SDs used in meta‐analysis based on what data: observed cases
Intention‐to‐treat analyses: generalised estimating equations
Selective reporting (reporting bias) High risk Protocol not available. Outcomes assessed with the DASS, which includes an anxiety subscale. Data on this outcome not reported, however.
Other bias High risk Trial conducted by those who developed the intervention
Implementation integrity Unclear risk Implementation integrity assessed: unclear if assessed
Implementation integrity adequate: N/A
Implementation integrity reported: N/A