4. List of included studies in Comparison 1 reporting adverse events data.
| Study | Approach to reporting adverse events | Count |
| Abrahams 2010 | Study explicitly states that there were no recorded adverse events. | 0/136 telephonic psychosocial support vs 0/138 minimal intervention |
| Anderson 2010 | Study highlights that, in terms of emotional processes at the session level, women in the CBT (CAED) group reported significantly greater levels of negative affect following each of the sessions (except Session 3), relative to the control group; however, it does not provide the numbers. It states, "Hence, overall the CAED sessions appeared to achieve the expected increase in negative affect." Beyond this, the study lacks specific information about recording of or actual adverse events and harms. | — |
| Bass 2016 | There was no reference to any methods around assessing adverse events or harms. Authors state, "We learned that it is possible to implement targeted strategies to include sexual violence survivors in VSLA groups in a safe and ethical manner, and that sexual violence survivors even those with severe trauma symptoms, can benefit from this participation." | — |
| Bell 2019 | The study lists a range of stressors that participants were exposed to during the study but does not provide numbers for these. They make the point that "many participants who were exposed to triggers and stressors reported feeling lower levels of stress reactivity and enhanced levels of self‐regulation in response to these stressors than they had prior to the study." The study refers to how stressors may confound the findings and acknowledges triggering experiences occurring in participants' lives but does not give attention to harms arising from its interventions. Notwithstanding this, there was just 1 withdrawal, and that was in the control (or minimal intervention) group. | — |
| Bomyea 2015 | "No participants experienced clinically significant deterioration." The authors acknowledge the high rate of treatment dropout but did not gather systematic data or reasons for this. Overall, the study does not report a systematic approach to recording adverse events and harms. | — |
| Bowland 2012 | Treatment dropout was low: "One did not attend any groups and was unable to be reached after the randomization procedure". Overall, the study does not report a systematic approach to recording adverse events and harms. | — |
| Brady 2021 | "Overall, retention in both arms of the trial was acceptable. Within the NET group, one individual discovered that she was in the advanced stages of pregnancy soon after allocation. It was not feasible for her to receive a full course of treatment, so she was withdrawn from the study. One individual dropped out of therapy after eight sessions, stating that they no longer wanted to engage in trauma‐focused therapy. All other participants in the NET group (n = 13) completed NET. In the wait‐list group, one participant was removed from the trial before the end of the waiting period owing to a significant increase in their risk of suicide. The remaining participants in the wait‐list group completed the waiting period. However, two participants dropped out of the study at the point of post‐wait assessment, owing to a deterioration in their physical health, and were therefore lost to follow‐up. The remaining participants in the wait‐list group were offered the opportunity to receive NET, and all took up this offer." The researchers make reference to deterioration in scores – for example, in the NET group, two people had worse scores on the CAPS‐5 – but this was not clinically significant, and we did not count it. | 0/15 narrative exposure therapy vs 1/10 minimal intervention (psychoeducation) |
| Falsetti 2008 | It is indicated that "Additionally, 16 participants dropped out of the study, including six individuals in the treatment group who attended only one session and 10 participants who dropped out at a later point in the study (two from the treatment group and eight from the control group)." However, reasons for treatment noncompletion are not furnished. There is no other reference to assessment of adverse events or harms in the study. | — |
| Foa 1991 | No specific reference to adverse events or harm is made. | — |
| Foa 1999 | The study provides an analysis of the differences in baseline characteristics between treatment completers and noncompleters but does not offer any explanations as to why people elected to exit the intervention. "More participants dropped out from SIT and PE‐SIT (27%) than from the PE and WL conditions (5%)… There were no significant differences between dropouts and completers on any of the pretreatment measures of psychopathology. A significant difference on one demographic variable emerged: nonworking participants (30%) were more likely to drop out than participants who were working full or part time (10%)." No specific reference to adverse events or harm is made. | — |
| Foa 2005 | Greater detail in this subsequent study by Foa and colleagues on the nature of events: "Twelve serious adverse events led to termination in the study, six of which are included in the postrandomization removal category in Figure 1 (4 participants reassaulted, 1 developing a life‐threatening illness, and 1 death). The remaining six serious adverse events were classified as drop‐outs (4 had severe depression and suicidal ideation that required immediate intervention, 2 of which were hospitalized, and 2 exhibited extreme dissociative symptoms)." This study also examined symptom worsening. Whilst this study has provided detail at the individual level not seen in others, it is limited by not providing events by group and thus cannot be meta‐analysed. | 12/179 |
| Foa 2006 | "Twenty‐four participants (26.7%) dropped out of the intervention, leaving 66 completers. Dropouts were distributed as follows: 9 (29%) in the B‐CBT condition, 10 (33.3%) in the AC, and 5 (17.2%) in the SC condition. The dropout rate did not differ across conditions…No significant differences between completers and dropouts emerged on pre‐intervention psychopathology and demographic variables." The authors state, "Finally, we did not collect systematic information about how many people were excluded from the study or the reasons why." Overall, this study lacks detail on adverse events and harms. | — |
| Gray 2020 | Dropout from this study was low – one person exited the post‐wait intervention group. The study states that "No reportable adverse events occurred" across the 30 randomised participants. | 0/15 RTM vs 0/15 waiting list |
| Krakow 2001 | Four participants were lost from the intervention. The study states, "Imagery rehearsal therapy produces imagery adverse effects; 4 patients reported increased negative imagery and eventually withdrew, and 12 of 66 who completed treatment did not complete follow‐up for unknown reasons." Some limitations around the potential for wider harms to be detected. | 4/88 CBT/IRT vs 0/80 waiting list |
| Littleton 2016 | This study was explicit about any increases in symptoms (PTSD, anxiety and depression) at the individual level, e.g. "No participants reported a clinically significant increase in PTSD symptoms from pre‐treatment to follow‐up. Two participants in the interactive program reported continued clinically significant increases in depression symptoms from pre‐treatment to follow‐up…One participant assigned to the psycho‐educational website also experienced a clinically significant increase in depressive symptoms from pre‐treatment to follow‐up. Finally, one additional participant in the interactive program reported a clinically significant increase in anxiety at follow‐up." This study shows positive attention to individual journeys through the treatment; however, it confines its assessment to the outcome measures. | 3/46 interactive CBT vs 1/41 minimal intervention website |
| Miller 2015 | Only 1 person is reported to not have tolerated the psychoeducation video; however, attrition was very high in this study at nearly 60%. "Participants were questioned about whether the examination or participating in research increased their distress. Overall, they responded that neither increased distress so this is unlikely to relate to the attrition." There is a lack of information about the qualitative component of this research. There are many unknowns in regard to the reasons why attrition was so elevated. | — |
| Rajan 2020 | Treatment completion was high, and attrition was low. "No harms were detected (i.e., there were no elevated scores on IES‐R, or NSESSS at time point two or three)." The authors explain, "Because this was the first randomized controlled treatment study conducted for the method, we followed the results in order to be able to detect adverse effects (i.e., elevated scores on self‐rating at time point two)." This study showed an awareness of monitoring adverse effects, although it appears to confine this to the outcome measures. | 0/21 modified lifespan integration vs 0/17 waiting list |
| Resick 2002 | This study makes some attempt to provide reasons for early postrandomisation withdrawals, though it is not systematic about this: "Of 181 women randomized into the trial, 10 were terminated from the study as a result of meeting exclusion criteria subsequent to new violence (women had to be at least 3 months posttrauma), changes in medication, or substance dependence relapse. Therefore, the intent‐to‐treat (ITT) sample included 171 women, among whom 13 never returned for the first session." The study provides an analysis on the differences in baseline characteristics between treatment completers and noncompleters but does not offer any explanations as to why a further 37 women left the treatment", "Thirty‐seven women dropped out of treatment, and 121 women completed treatment along with at least the posttreatment assessment: 41 CPT clients, 40 PE clients, and 40 MA clients. Dropout rates for the two active treatment groups were similar: 26.8% for CPT and 27.3% for PE. In the MA condition, 14.9% did not return for the second assessment. There were no significant differences between women who dropped out of therapy and those who completed therapy with regard to their initial PTSD or depression scores." This study lacks a systematic approach to recording adverse events and harms. | — |
| Rothbaum 1997 | No specific statement on adverse events or harm is offered; however, reasons for attrition of 3 people in the study are provided, and none raise concerns. | — |
| Rothbaum 2005 | "Of the 74 women enrolled in the study, 1 dropped out during the assessment phase, 1 was terminated and referred during treatment for not meeting treatment criteria, 12 dropped out during treatment, and 60 women (83.3%) completed the protocol. The dropout rate across the three groups was not significantly different, PE: 13.0% (n = 3, 2 before MID); EMDR: 20.0% (n = 5, 4 before MID); and WAIT: 16.7% (n = 4)." This study lacks a systematic approach to recording adverse events and harms. | — |
| Sikkema 2018 | This study highlights the barriers to gaining reasons for treatment noncompletion when people are not contactable: of the 13 who left the treatment, 12 were not reachable and 1 had scheduling issues; of the 6 who exited the standard care condition, 4 were not reachable and 2 had scheduling issues. In terms of attrition, "Participants lost to follow‐up at the 6‐month assessment were significantly more likely than those retained to have reported hazardous drinking (69.2% vs. 37.3%, p = 0.04) and recent physical intimate partner violence at baseline (46.2% vs. 17.65%, p = 0.03)." This study lacks a systematic approach to recording adverse events and harms. | — |
| Walsh 2017 | "The PANAS was administered pre‐exam as a measure of potential differences in distress across groups as well as post‐exam as a validity check regarding intervention condition." We did not see any reporting of scores beyond as a check when a change in length of the video was introduced. This study lacks a systematic approach to recording adverse events and harms. | — |
AC: assessment control; B‐CBT: brief cognitive behaviour therapy; CAED: Clinician‐Assisted Emotional Disclosure; CAPS‐5: Clinician‐Administered PTSD Scale for DSM‐5; CBT: cognitive behavioural therapy; CPT: cognitive processing therapy; EMDR: eye movement desensitisation and reprocessing; IES‐R: Impact of Event Scale – Revised; IRT: imagery rehearsal therapy; MA: minimal attention condition; MID: minimally important difference; NET: narrative exposure therapy; NSESSS: National Stressful Events Survey PTSD Short Scale; PANAS: Positive and Negative Affect Schedule; PE: prolonged exposure; PE‐SIT: prolonged exposure combined with stress inoculation therapy; PTSD: post‐traumatic stress disorder; RTM: reconsolidation of traumatic memories; SC: supportive counselling; SIT: stress inoculation therapy; VSLA: Village Savings and Loans Associations; WAIT: wait‐list control; WL: wait‐list