Assessing approaches aimed at improving sexual functioning

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Participants will be randomised on a 1:1 allocation ratio using a remote web‐based randomisation system to either enhanced standard care plus a switch in antipsychotic medication or enhanced standard care alone. Enhanced standard care All study participants will be offered two sessions of enhanced standard care comprising usual treatment plus brief advice and support to discuss their sexual health and functioning. Antipsychotic switch In addition to enhanced standard care, those in the “switch” arm of the trial will be offered a change in their current antipsychotic medication to a choice of three antipsychotics with a lower tendency to cause sexual dysfunction: aripiprazole, quetiapine and olanzapine. Patients will be recruited from NHS community mental health services and followed up for 6 months. CONDITION: Specialty: Mental health, Primary sub‐specialty: Psychosis ‐ schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders ; Mental and Behavioural Disorders ; Schizophrenia PRIMARY OUTCOME: Patient reported sexual dysfunction measured using the Arizona Sexual Experience scale (ASEX) at baseline, 3 and 6 months. Primary outcome at 6 months. SECONDARY OUTCOME: 1. Sexual behaviour measured using questions from the National Survey of Sexual Attitudes and Lifestyles (NATSAL) at baseline and 6 months; 2. Researcher‐rated sexual functioning measured using the Clinical Global Impression for Sexual Functioning at 6 months; 3. Mental health measured using the total score on the Positive and Negative Syndrome Scale (PANSS) at baseline and 6 months; 4. Side effects of medication measured using the Antipsychotic Non‐Neurological Side Effects Scale (ANNSERS) at baseline and 6 months; 5. Medication adherence measured using the Brief Adherence Rating Scale (BARS) at baseline and 6 months; 6. Quality of life measured using the European Quality of Life‐5 Dimensions (EQ‐5D‐5L) 40 and the Recovering Quality of Life (REQOL) questionnaire at baseline and 6 months; 7. Resource use measured using the Adult Service Use Schedule (AD‐SUS) at baseline and 6 months INCLUSION CRITERIA: 1. Men or women aged 18 or over 2. A clinical diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified, as defined by DSM‐IV 3. Sexual dysfunction associated with antipsychotic medication for whom reducing the dose of their current antipsychotic was either not effective or not appropriate 4. Assessed by their clinical team as not having an underlying physical condition that is responsible for their sexual dysfunction
Epistemonikos ID: 848bb4774b2ee14ca76d30f90697fffbf9443be7
First added on: Aug 24, 2024