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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Huguelet 2011.

Methods Randomized controlled trial
Participants The study location was the Department of Psychiatry at the University Hospitals of Geneva
42 participants were randomized to the intervention group and 42 participants were randomized to the control group
The inclusion criteria were no hospitalization in the previous 6 months (stability) and treated by their current psychiatrist for at least 3 months (familiarity)
The exclusion criterion was inability to participate in the intervention due to their clinical condition
Interventions Intervention: RELIGIOUS AND SPIRITUAL ASSESSMENT
 The intervention was delivered by psychiatrists who were trained by the researchers. Psychiatrist attended a 90‐minute training session during which they were informed about the rationale for taking into account the spiritual dimension in the treatment of patients with schizophrenia and how to conduct a spiritual assessment. They were made aware of how their own religious and spiritual experiences could influence their identity and world view, as well as how their attitudes toward such experiences might introduce biases into clinical assessment and treatment. Finally, psychiatrists were reminded to show respect for patients with different religious and spiritual backgrounds. Psychiatrists used a semi‐structured interview guided by the following topics: religious and spiritual history, effects of illness on spirituality or religiousness, current spiritual or religious beliefs and practices, subjective importance of religion in general, subjective importance of religion in coping with the illness, synergy of religion with psychiatric care. After each assessment the psychiatrist met with 2 of the authors, a psychiatrist and a psychologist of religion. In these sessions the individual patient was discussed for 10 to 40 minutes, depending on the clinical context. The participating psychiatrist reported the outcome of his or her spiritual assessment and was given guidance and advice, similar to clinical coaching; when needed, a more thorough discussion from a psychotherapeutic perspective was undertaken
Control: USUAL CARE
 "For the control group, psychiatrists were instructed to avoid speaking about religious issues during the three‐month follow‐up period unless patients spontaneously brought up the subject." (pg 81)
Outcomes The measures of adherence were Medication Adherence Rating Scale. It was administered at baseline and at the 3‐month assessment
The patient outcomes were psychosocial adaptation measured with Global Assessment Function, Social Functioning Questionnaire and World Health Organization Quality of Life Instrument; satisfaction with care measured with Client Satisfaction Questionnaire and Working Alliance Inventory; change in symptoms as measured with Positive Negative Scale and Recovery Assessment Scale. All measurements were carried out at baseline and at completion of the 3‐month intervention by trained and blinded psychologists
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The authors state that they assigned the patients a random number but it is not clear how they came up with these random numbers (e.g. coin tossing, random number etc?). "To ensure random selection, all eligible patients of each psychiatrist were assigned a random number and then listed in numerical order. Up to 14 patients per clinician were selected. The first seven patients on the numerical list were assigned to the intervention group, which receive standard treatment plus a spiritual assessment by their psychiatrist. The last seven patients on the list were assigned to the control group, which received only standard treatment." (pg 80)
Allocation concealment (selection bias) High risk Their method of allocating patients to treatment groups is not concealed: "To ensure random selection, all eligible patients of each psychiatrist were assigned a random number and then listed in numerical order. Up to 14 patients per clinician were selected. The first seven patients on the numerical list were assigned to the intervention group, which receive standard treatment plus a spiritual assessment by their psychiatrist. The last seven patients on the list were assigned to the control group, which received only standard treatment." (pg 80)
Selective reporting (reporting bias) Unclear risk Protocol not available
Other bias Unclear risk Several limitations have been listed by the authors but how they might have influenced the result is unknown. (pg 84) "The study had some limitations. First, cultural context is likely to have influenced the results, and the study should be replicated in other areas. Only patients in the intervention group received additional attention from the psychiatrists, who explored and discussed patients' personal beliefs, which may have introduced significant bias. The additional time invested by the psychiatrists could have made a difference, an effect having little to do with the focus on spiritual issues. Furthermore, psychiatrists received supervision only for patients in the intervention group, and supervision itself could have altered patients' outcomes. Patients signed an informed consent form to participate in the study and then were randomly assigned to the intervention or control group. The latter patients might have been disappointed at not having received a spiritual assessment, which may have altered their evaluations. Other limitations were noted above: the short training session and the lack of commitment among some clinicians."
Blinding of outcome assessment (detection bias) 
 Adherence measure Unclear risk (PRIMARY) MEDICATION ADHERENCE RATING SCALE ‐ It is not clear who administered and collected the questionnaire data
Blinding of outcome assessment (detection bias) 
 Patient outcome Low risk (PRIMARY) CLIENT SATISFACTION QUESTIONNAIRE ‐ (pg 81) "Assessment was performed by trained psychologists blind to the patient's group assignment."
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) MEDICATION ADHERENCE RATING SCALE ‐ This is a subjective measure of adherence. The following quote suggests that the patients probably knew their group assignment: "Patients signed an informed consent form to participate in the study and then were randomly assigned to the intervention or control group. The latter patients might have been disappointed at not having received a spiritual assessment, which may have altered their evaluations."
Blinding of participants (performance bias) 
 Patient outcome High risk (PRIMARY) CLIENT SATISFACTION QUESTIONNAIRE ‐ The questionnaires were a subjective measure, answered by the patients. The following quote suggests that the patients probably knew their group assignment: "Patients signed an informed consent form to participate in the study and then were randomly assigned to the intervention or control group. The latter patients might have been disappointed at not having received a spiritual assessment, which may have altered their evaluations."
Blinding of personnel (performance bias) 
 Adherence measure Unclear risk (PRIMARY) MEDICATION ADHERENCE RATING SCALE ‐ No information is provided about the blinding of key personnel
Blinding of personnel (performance bias) 
 Patient outcome Unclear risk (PRIMARY) CLIENT SATISFACTION QUESTIONNAIRE ‐ Insufficient information for judgment
Incomplete outcome data (attrition bias) 
 Adherence measure High risk (PRIMARY) MEDICATION ADHERENCE RATING SCALE ‐ Missing data not balanced across the groups. Reason for missing is not given
Incomplete outcome data (attrition bias) 
 Patient outcome High risk (PRIMARY) CLIENT SATISFACTION QUESTIONNAIRE ‐ Missing data not balanced across the groups. Reason for missing data is not given