Hubschmid 2015.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group Adequate power (evidence of power calculation): no information provided Allocation concealment method: randomisation to IPI or SC was done through 24 identical, non‐transparent, sealed envelopes, half containing a paper stipulating 'treatment' and the other half 'standard'. Blinding of outcome assessors: no, to minimise dropout of participants Check of blinding: no blinding Duration of study: November 2010 to January 2013 Randomisation method: randomisation to IPI or SC using 24 identical, non‐transparent, sealed envelopes, half containing a paper stipulating 'treatment' and the other half 'standard.' Envelopes were independently prepared and sealed, and given to a third person unaware of the content to mix. They were numbered consecutively and given in chronological order to patients as written informed consent was signed. |
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Participants |
Baseline characteristics Intervention
Control
Overall
Inclusion criteria: aged 16–65 years; newly diagnosed conversion disorder according to the (DSM‐IV‐TR) (within 12 months) with motor or NEA symptoms assessed by experienced neurologists. Exclusion criteria: lack of verbal fluency in French; neurological comorbidity with motor or gait symptoms, or concomitant epilepsy diagnosed by an experienced epileptologist; psychiatric comorbidity of psychosis, acute suicidality or current substance abuse; or current psychotherapy at the time of inclusion. Pretreatment: no statistically significant differences at baseline between groups. |
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Interventions |
Intervention characteristics Intervention
Control
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Outcomes |
Conversions symptoms (SDQ‐20)
Quality of life (SF‐36)
Use of health service emergency department
Mental state – depression (BDI‐II),
Dropout
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Notes | The use of health services at 4 and 10 months' follow‐up were not included in this review, as data did not allow for inclusion in the analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization to IPI or SC was done through 24 identical, nontransparent, sealed envelopes, half containing a paper stipulating "treatment" and the other half “standard." The envelopes were independently prepared by H.M. and sealed, and then given to a third person unaware of their content to mix. They were numbered consecutively and given in chronological order to patients as written informed consent was signed." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization to IPI or SC was done through 24 identical, nontransparent, sealed envelopes, half containing a paper stipulating "treatment” and the other half "standard." The envelopes were independently prepared by H.M. and sealed, and then given to a third person unaware of their content to mix. They were numbered consecutively and given in chronological order to patients as written informed consent was signed." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No blinding of personnel delivering the intervention to keep participants throughout the study. So the authors had actively made a decision. Nothing mentioned for participants. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "This trial was not blinded, as part of the measures was rated by the therapists themselves, to try and limit the dropout rate. Other measures were self‐administered." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts accounted for. |
Selective reporting (reporting bias) | Low risk | No changes to trial outcomes were made after trial started. The following outcome measures were analysed as per protocol. |
Other bias | Low risk | No other apparent sources of bias. |