Chibanda 2016.
| Study characteristics | ||
| Methods |
Study design: cluster‐RCT (unit of allocation: primary care clinics. 12 clinics in each arm, 24 in total) Duration of study: 1 September 2014 to 25 May 2015 |
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| Participants |
Country: Zimbabwe Income classification: low income Geographical scope: Harare, Zimbabwe Healthcare setting: PC facility Mental health condition: common mental disorders Population 1. Age: 18 and above 2. Gender: both 3. Socioeconomic background: not mentioned 4. Inclusion criteria a. All persons residing in the area and attending local clinics who are aged 18 and above and are able to give written informed consent will be eligible for enrolment b. Individuals scoring at or above a cutoff point of 9 on the SSQ‐14 will be invited to participate 5. Exclusion criteria a. Persons who are unable to comprehend the nature of the study in either English or Shona (local language) b. Those with suicidal intent, end‐stage AIDS, currently in psychiatric care, or presenting with current psychosis, intoxication, and/or dementia c. Those excluded for medical reasons will be referred for appropriate care to 1 of 2 tertiary facilities in Harare d. Those reported to be physically unwell by the clinic Nurse‐in‐Charge e. Pregnant women in the third trimester and women within the 3 months post delivery period f. Those not residing in the geographical locality or whose address cannot be verified through clinic registries |
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| Interventions |
Stated purpose: to evaluate effectiveness of this culturally adapted intervention for common mental disorders delivered by existing LHWs in primary care in Harare, Zimbabwe INTERVENTION (n = 260) Name: Friendship Bench Intervention Delivered by: LHWs Title/name of PW and number: community workers (lay health workers) 1. Selection: LHW was attached to the clinic and employed by the local health authority; all were female 2. Educational background: mean of 10 years education 3. Training: 9 days' training. Topics included common mental disorders, counselling skills, problem‐solving supported with a manual developed by Friendship Bench team 4. Supervision: LHWs will receive supervision and support from the clinical team at the site level or through mobile phones using voice calls and, when necessary, SMS messaging. The SMS messaging/voice call will be sent by the LHW, and when challenges such as being unable to contact a participant are encountered, project co‐ordinators will follow up with a voice call; if this yields no results, a physical home visit will be carried out. The support structure is based on a predetermined algorithm developed during formative research. This consists of study screen tool cutoff scores, criteria for referral including assessment for “red flags”, clients who are suicidal, and immediate referral to a tertiary facility 5. Incentives/remuneration: not mentioned Intervention details 1. Duration/frequency: 6 weekly sessions of 30 to 45 minutes delivered through the Friendship Bench over 6 weeks, including home visits when deemed necessary 2. Content of intervention: Friendship Bench intervention is problem‐solving therapy, in which the patient identifies a problem (e.g. unemployment) rather than a diagnosis or symptom; this has been shown to be feasible and acceptable in this resource‐poor setting. The psychological approach of problem‐solving therapy works by enabling a more positive orientation towards resolving problems and empowering people to have a sense of greater coping and control over their lives 3. Lay health workers followed a detailed script contained in a manual to conduct 6 sessions on a bench located in a discreet area outside the clinic 4. The care model was driven by a trained and supervised LHW attached to the clinic and employed by the local health authority. After 6 sessions of individual therapy, the LHW referred those not improving or with suicidal ideation to a supervisor trained in mental health to re‐assess and manage the case if needed 5. Participants in the intervention group received up to 6 text messages, phone calls, or both during the intervention, which reinforced the problem‐solving therapy approach and encouraged participants, particularly those attending fewer than 3 sessions during the first 4 weeks, to follow their action plan. As part of the improved management programme, participants were re‐assessed by the LHW after the third session using the SSQ‐14, and those whose score had worsened by 1 or more scale points or who had suicidal ideation were assessed by a psychiatrist. These results were not used for research purposes. If participants missed a session, the LHWs followed up with a phone call, a home visit, or both if there was no response 6. After 4 individual sessions, all intervention group participants were invited to join a peer‐led group called Circle Kubatana Tose, or “holding hands together”. These weekly meetings consisted of sharing personal experiences while crocheting a bag from recycled plastic materials. The latter activity was a skill for generating income by making and selling the bags. Participants in the intervention group were also offered enhanced usual care (EUC) CONTROL (n = 261) The control group received the standard usual care consisting of a nurse‐led evaluation, brief support counselling, and an option for medication, as well as information, education, and support for common mental disorders including assessment for antidepressant medication prescribed by the clinic nurse, referral to a psychiatric facility, or both if needed. Participants also received 2 to 3 supportive Short Message Service messages or calls, with the last message a reminder to attend the 6‐month assessment CO‐INTERVENTIONS: nil |
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| Outcomes |
Patients 1. Continuous: SSQ‐14; PHQ‐9; GAD‐7; WHODAS.2.0; EQ‐5D 2. Binary: PHQ‐9 ≥ 11, PHQ‐9 diagnostic algorithm, GAD ≥ 10, SSQ‐14 ≥ 9, WHODAS2.0 ≥ 20 Carers Nil Process/health workers Nil Economic outcomes Nil Time points: baseline, 6 months |
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| Notes |
Source of funding: Grand Challenges Canada (grant KCU‐0087‐042) Notes on validation of instruments (screening and outcomes): all validated Additional information: declarations of interest ‐ study authors reported no conflict of interest Handling the data: as per footnotes in data and analysis Prospective trial registration number: PACTR201410000876178 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "on each day of screening, computer‐generated preprinted random numbers were used to select clinic attenders based on their queue position number" Judgement comment: random allocation of patients with computer‐generated lists. Also randomisation of clinics (not specified how) |
| Allocation concealment (selection bias) | Low risk | Quote: "the research assistants responsible for outcome assessment were masked to the allocation" Judgement comment: allocation was conducted by city health staff not involved in the study and was blinded to the study team. Allocation unit was clearly specified Therefore, low risk |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Participants in both groups were not aware which group was the intervention" Interventionists were unlikely to be blinded, but this was unlikely to have influenced outcomes |
| Blinding of outcome assessment (detection bias) all outcomes | Low risk | "Research assistants conducting follow‐up interviews in the clinics could have ascertained allocation by the presence of the bench, but we attempted to minimise bias by keeping research assistants independent of intervention delivery and implementation" Therefore, low risk |
| Baseline outcome measurements similar | Low risk | Mean SSQ‐14 score at baseline similar between groups. Other measures mostly similar; PHQ showed participants with high scores in the intervention group |
| Baseline characteristics similar? | Low risk | Participants in the intervention group were more likely to be women, younger, and better educated, and were less likely to be HIV positive COMMENTS Some differences in baseline characteristics but not very large |
| Incomplete outcome data (attrition bias) Efficacy data | Low risk | "Because of a high 6 month follow up rate (91%), complete case analysis was used, and missing data were not imputed at the individual level" Missing data unlikely to bias results; therefore low risk "Data were not imputed for 9% of participants lost to follow‐up and with missing data. However, missing outcome was associated with baseline SSQ‐14, PHQ‐9, and WHODAS2.0 scores, and the complete‐case analysis should therefore be unbiased" 26 dropouts in each group; all clinics included in analyses |
| Incomplete outcome data (attrition bias) Safety data (e.g. adverse events) | Low risk | Reasons for dropout were reported. Study authors report no evidence of harm. Proportions of missing data were similar in intervention and control groups |
| Protection against contamination | Low risk | Judgement comment: allocation by primary care clinic |
| Selective reporting (reporting bias) | Unclear risk | Protocol is published; primary outcome is the same but not all secondary outcomes are specified in the protocol. All outcomes described in methods are reported |
| Other bias | Low risk | No other sources of bias were found |