Ertl 2011.
| Study characteristics | ||
| Methods |
Study design: RCT Duration of study: trial conducted between November 2007 and October 2009 (last follow‐up). Preceded/overlapped by an epidemiological survey July 2007 to April 2008 |
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| Participants |
Country: Uganda Income classification: low income Geographical scope: rural and urban; takes place in IDP camps and new settlement areas in 3 regions of Northern Uganda: Anaka: rural area with the most documented rebel activity; Awer: urban relatively safe area close to large town called Gulu, Padibe; rural (long distance from Gulu and more affected by the war) Healthcare setting: home Mental health condition: child mental disorder ‐ PTSD Population: patients; children/adolescents (child soldiers) 1. Age: 12 to 25 years; mean age 18.66 years (SD 3.77) 2. Gender: both 3. Socioeconomic background: former child soldiers; mean economic status in Euros (as measured by household possessions weighted by current local market prices divided by household size): EUR44‐55 4. Inclusion criteria a. Clinical diagnosis of PTSD derived from expert interviews b. Member of the group of formerly abducted people or former child soldiers c. Note: to keep the trial naturalistic, we did not exclude patients with suicidal ideation, substance abuse, or depression 5. Exclusion criteria a. Current substance dependence b. Mental retardation c. Psychotic disorder |
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| Interventions |
Stated purpose: to examine whether individual‐based, trauma‐focused NET is feasible and effective in reducing PTSD symptoms among traumatised former child soldiers living in the IDP camps of Northern Uganda when carried out by trained local lay therapists directly in communities INTERVENTION 1 (n = 29) Name: NET Delivered by: LHWs Title/name of PW and number: local lay counsellors ‐ 14 (7 women, 7 men) 1. Selection: not specified 2. Educational background: not specified 3. Training: training in and performance of NET were as outlined by an adapted field version of manual, duration, and trainers: unspecified 4. Supervision: "treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session. In the case of NET, testimonies were additionally reviewed to check for trauma focus and richness of detail" ‐ not specified by whom 5. Incentives/remuneration: not specified Intervention details 1. Duration/frequency: 8 sessions of individual therapy; "sessions lasted between 90 and 120 minutes and were scheduled 3 times a week" 2. Content of intervention: "we chose an individual‐based over a group‐based treatment, because we expected this approach to better meet the requirements of former child soldiers, who present with high levels of PTSD as well as mistrust"; "narrative exposure therapy is a short‐term, trauma‐focused treatment developed for use in low‐resource countries affected by crises and conflict. Intended for survivors of multiple trauma, this therapy results in the detailed documentation of the patients' lives as part of the therapy process"; "irrespective of treatment condition, the first session included psychoeducation on PTSD, its symptoms and consequences for the individual, and explanation of the rationale for narrative exposure therapy or academic catch‐up". Participant constructs chronological account of self biography with therapist and reconstructs fragmented memories of traumatic events and habituation INTERVENTION 2 (n = 28) Name: Academic Catch‐up Training Delivered by: lay PHWs Title/name of PHW/CW and number: local lay counsellors ‐ 14 (7 women, 7 men) 1. Selection: not specified by whom 2. Educational background: not specified by whom 3. Training: written guidelines that summarised basic counselling skills and session outlines for academic catch‐up training; duration and trainers unspecified 4. Supervision: "treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session". Not specified by whom 5. Incentives/remuneration: not specified by whom Intervention details 1. Duration/frequency: 8 sessions of individual therapy; "sessions lasted between 90 and 120 minutes and were scheduled 3 times a week" 2. Content of intervention: "carried out according to written guidelines that summarized basic counselling skills and session outlines for the academic catch‐up training"; "irrespective of treatment condition, the first session included psychoeducation on PTSD, its symptoms and consequences for the individual, and explanation of the rationale for narrative exposure therapy or academic catch‐up"; "an intensive English catch‐up course using the official Ugandan schoolbooks for different skill levels was developed. Evaluation of process notes revealed that counsellors spent 55% of total time allocated for academic catch‐up doing academic training. The rest of the time was equally dedicated to providing psychoeducation, conducting discussions on coping with symptoms, and dealing with current problems. None of the counsellors deviated from the restriction that they should not focus on traumatic experiences in this condition. In the last session, participants received the English textbooks and exercise books they had been working on with their counsellors" CONTROL (n = 28) Wait‐list control; 10 received suicide intervention due to suicidal ideation. "After the 12‐month follow‐up, each waiting‐list and academic catch‐up participant still presenting with PTSD was offered narrative exposure therapy" CO‐INTERVENTIONS: wait list with suicide intervention for those who exhibited high levels of suicide ideation (10 people) |
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| Outcomes |
Patients 1. PTSD symptom load* (Clinician‐Administered PTSD Scale ‐ CAPS) 2. Functional impairment* (CAPS) 3. Guilt § (CAPS) 4. Symptoms of depression (MINI Neuropsychiatric Interview for depression module A ‐ MINI) 5. Suicidal ideation (MINI) 6. Stigmatisation § (Perceived Stigmatization Questionnaire ‐ PSQ) Carers N/a Process/health workers 1. "Treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session. In the case of narrative exposure therapy, testimonies were additionally reviewed to check for trauma focus and richness of detail. No deviations from the study protocol were noted" 2. None reported in the study § Economic outcomes None (*: primary outcomes of the study; §: outcomes that we have not reported in this review) Time points: baseline; 3‐, 6‐, and 12‐month follow‐up |
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| Notes |
Source of funding: this study was supported by the NGO vivo and by funding from the DFG (Deutsche Forschungsgemeinschaft) and the Ein Herz für Kinder Foundation Notes on validation of instruments (screening and outcomes): CAPS and MINI validated; PSQ not validated Additional information:clinicaltrialsgov/show/NCT00552006. Declaration of interests ‐ study authors reported no competing interests Handling the data: as per footnotes in data and analysis Prospective trial registration number: NCT00552006 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: randomly selected, but study does not specify how |
| Allocation concealment (selection bias) | Unclear risk | Comment: unspecified |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: unspecified |
| Blinding of outcome assessment (detection bias) all outcomes | Low risk | Quote: "pretreatment assessments as well as follow‐up assessments at 3 months, 6 months, and 12 months after treatment were conducted by 13 clinical psychologists blinded to treatment conditions" Comment: appropriate blinding; no objective outcomes |
| Baseline outcome measurements similar | Low risk | Comment: no statistical differences Quote: "there were no systematic pretreatment differences in sociodemographic data, traumatic load, and psychological impairment between the 3 groups" |
| Baseline characteristics similar? | Low risk | Comment: no statistical differences Quote: "there were no systematic pretreatment differences in sociodemographic data, traumatic load, and psychological impairment between the 3 groups" |
| Incomplete outcome data (attrition bias) Efficacy data | Low risk | Comment: 3‐month follow‐up: 26 included and 2 discontinued in NET; 24 included, 2 discontinued, and 1 died in academic catch‐up (ACU) at 6 months' follow‐up; 26 included in NET, 23 included, 1 not found in ACU at 12 months' follow‐up; 25 included, 1 loss to follow‐up, 23 in NET; all 28 wait‐list participants remained throughout treatment Quote: "apart from providing participants with the written documentation of their lives or with the English textbooks and exercise books, no incentives were offered. During follow‐up periods, individuals who had relocated far from the former IDP camps were refunded travel expenses" Comment: this would have reduced attrition; unlikely to have affected outcomes |
| Incomplete outcome data (attrition bias) Safety data (e.g. adverse events) | Low risk | Comment: no negative effects of NET were observed in this trial. Clinically reliable aggravation of symptoms was not present in the NET group but was present in 4.4% of academic catch‐up and in 10.7% of waiting list participants |
| Protection against contamination | Low risk | Comment: lay counsellors were instructed not to integrate treatment material from NET to ACU |
| Selective reporting (reporting bias) | Low risk | Comment: all pre‐specified outcomes in protocol were reported |
| Other bias | Low risk | Comment: none were detected |