Sikkema 2013.
Methods |
Trial design: 3‐arm RCT Follow‐up: baseline, post, 4, 8, 12 months Loss to follow‐up: minimal loss to follow‐up, ITT analysis done |
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Participants |
Population: 247 HIV‐positive men (N = 117) and women (N = 130), intervention = 124, control = 123 Inclusion: sexual abuse as a child (age 12 and under) and/or adolescent (age 13 to 17 years); current age of 18 or older; HIV serostatus Exclusion: acute distress due to sexual revictimization experienced within past month; presence of impaired mental status; extreme distress or depressive symptomatology |
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Interventions |
Treatment 1: N= 124. HIV and Trauma Coping Group Intervention (LIFT) where participants Identify stressors that they perceived to be related to their sexual abuse experiences and those related to their HIV diagnosis, learn adaptive coping and risk reduction skills related to both sexual abuse and HIV infection.
Control: N = 123. HIV standard therapeutic support group. The comparison intervention paralleled a standard therapeutic support group and was led by experienced co‐therapists not trained on the coping intervention model. The purpose of the group was to provide a supportive environment for participants to address issues of HIV and trauma. |
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Outcomes |
Included in this review
Not included in this review
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Notes |
Setting: Community Health Centre Country: USA Different populations in each report |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial authors described the trial as 'randomized' but did not provide any further details. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not describe the method of allocation concealment, if any. |
Blinding of participants and personnel (performance bias) Anxiety | Unclear risk | The trial authors did not describe the method of blinding, if any. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial authors did not describe the method of blinding, if any. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up: 16.5% Intervention group versus 33.3% control. The trial authors conducted an intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | We did not detect any other sources of selective reporting bias. |
Other bias | Low risk | We did not detect any other potential sources of bias. |
Abbreviations: HAART: highly active antiretroviral therapy; PMR: progressive muscle relaxation; RCT: randomized controlled trial.