Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms

Conditions

Obsessive-compulsive disorder Mental and Behavioural Disorders Obsessive-compulsive disorder

Naomi Fineberg, Eduardo Cinosi, Megan Smith, Amanda Busby, David Wellsted et al. (17 authors)

Comprehensive Psychiatry2023-01-2623 citations

10.1016/j.comppsych.2023.152371

Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD)

Eduardo Cinosi, David Adam, Ibrahim H. Aslan, David S. Baldwin, Kieran Chillingsworth et al. (23 authors)

Pilot and Feasibility Studies2021-12-015 citations

10.1186/s40814-021-00945-6

Interventions

In this study, treatment-seeking adults with OCD are recruited from mental health units, GP referrals and improved access to psychological therapies services. Twenty-five patients with OCD will receiv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Community-based service-users, aged 18-65 years 2. DSM-5 defined obsessive-compulsive disorder determined by a research psychiatrist using the structured interview for DSM-5 3. Duration of symptoms > 1 year (from medical history) 4. Baseline score >= 20 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 5. Ongoing medication (SSRI, tricyclic antidepressant, antipsychotic, benzodiazepine) is allowed as long as the dose is kept stable for a sustained period before (> = 6 weeks) randomisation and remains so throughout the study. CBT is not allowed during or within 6 weeks of the start of the intervention

Exclusion criteria

Exclusion criteria: 1. History of psychotic disorder (schizophrenia, psychotic symptoms, bipolar disorder), Tourette syndrome (tic disorders not amounting to Tourette syndrome will not be exclusionary), organic mental disorder, psychosurgery, personality disorder of borderline or histrionic type 2. Alcohol/substance-abuse disorders within the past 12 months 3. Any other DSM-5 disorder that is considered the primary focus of treatment 4. Severe depression, defined by a Montgomery-Åsberg Depression Rating Scale (MÅDRS) score > 30 at baseline 5. Actively planning suicide (scoring 5 or 6 on item 10 of MADRS) or judged by the clinician to be at significant risk of self-harm 6. Received CBT involving ERP from an accredited (British Association of Behavioural and Cognitive Psychotherapies (BABCP) approved or equivalent) therapist (e.g. IAPTs stage 2) in the last 6 weeks 7. Highly CBT resistant (inadequate clinical response, equivalent to = 3 previous adequate (> 12 weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist 8. Highly medication resistant (inadequate clinical response, equivalent to = 3 previous adequate (> 12 weeks) trials of any SSRI or clomipramine taken at optimal doses with adequate adherence 9. Needing regular psychotropic drugs other than permitted medication 10. Currently involved in a treatment research study 11. Acute or unstable physical illness 12. Skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites 13. History of surgical procedure with implanted body materials or devices (e.g. metal, pacemakers) 14. Epilepsy or other clinically defined neurological disorder or insult 15. Inadequate understanding of English to give informed consent or such that the outcome measurement is impossible 16. Women of child-bearing age not using reliable contraception (e.g. oral contraception pill, intra-uterine contraceptive device or condom) 17. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
1. Acceptability, tolerability and safety of the intervention is determined using treatment logs recorded during and following study visits. Specifically: 1.1. Sessions completed and missed (acceptability, tolerability) 1.2. Recording of issues raised by patients at any point during the study. Adverse events reported at any point, specifically recorded at study visits (safety) 2. Feasibility of recruitment is determined using logs of referral into the services, by recording the numbers of potential patients, as well as why patients were excluded at each point, and the number of patients consented. 3. Adherence to tDCS and the study protocol assessed by recording sessions, and the proportion of study outcomes completed is determined using notes on issues raised by patients and researchers that are recorded during the study. 4. Willingness evaluated by recording the numbers of key staff approached, those declining study participation and the reasons given. 5. tDCS in a clinical setting assessed by recording any issues relating to setting up the sessions, delivery of the stimulation, and issues raised by the participants during or in the hours after the stimulation sessions. Difficulties with the application of the treatment protocols and equipment failures are noted	—

Measure

Time frame

1. Acceptability, tolerability and safety of the intervention is determined using treatment logs recorded during and following study visits. Specifically: 1.1. Sessions completed and missed (acceptability, tolerability) 1.2. Recording of issues raised by patients at any point during the study. Adverse events reported at any point, specifically recorded at study visits (safety) 2. Feasibility of recruitment is determined using logs of referral into the services, by recording the numbers of potential patients, as well as why patients were excluded at each point, and the number of patients consented. 3. Adherence to tDCS and the study protocol assessed by recording sessions, and the proportion of study outcomes completed is determined using notes on issues raised by patients and researchers that are recorded during the study. 4. Willingness evaluated by recording the numbers of key staff approached, those declining study participation and the reasons given. 5. tDCS in a clinical setting assessed by recording any issues relating to setting up the sessions, delivery of the stimulation, and issues raised by the participants during or in the hours after the stimulation sessions. Difficulties with the application of the treatment protocols and equipment failures are noted

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Secondary

Measure	Time frame
Current secondary outcome measures as of 24/07/2019: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate)scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation). 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation. 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests usingY-BOCS and Y-BOCS Challenge at all time points following the first stimulation. 4. Usefulness and limitations of specific neurocognitive tests is measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), andFabulous Fruit game (habit learning test) at baseline and 3 hours. Previous secondary outcome measures: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate) scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation) 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests using Y-BOCS and Y-BOCS Challenge at all timepoints following the first stimulation 4. Usefulness and limitations of specific neurocognitive tests are measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), and Fabulous Fruit game (habit learning test) at baseline and 3 hours	—

Measure

Time frame

Current secondary outcome measures as of 24/07/2019: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate)scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation). 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation. 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests usingY-BOCS and Y-BOCS Challenge at all time points following the first stimulation. 4. Usefulness and limitations of specific neurocognitive tests is measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), andFabulous Fruit game (habit learning test) at baseline and 3 hours. Previous secondary outcome measures: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate) scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation) 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests using Y-BOCS and Y-BOCS Challenge at all timepoints following the first stimulation 4. Usefulness and limitations of specific neurocognitive tests are measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), and Fabulous Fruit game (habit learning test) at baseline and 3 hours

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Countries

England, United Kingdom

Outcome results

None listed