Obsessive-compulsive disorder Mental and Behavioural Disorders Obsessive-compulsive disorder
Conditions
Interventions
This feasibility study uses treatment manuals or written protocols
the therapists will be trained to provide combination treatment ERP with HRT (experimental treatment) and ERP monotherapy (Treatment As Usual - (TAU))
treatment integrity will be checked e.g. by evaluating an audio recorded session, and an assessor blinded to both treatment conditions will be used to evaluate the pre and post outcome measures.
Stud
Sponsors
Hertfordshire Partnership University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Obsessive-Compulsive Disorder as a diagnosis confirmed using the MINI International neuropsychiatric inventory 2. Minimum OCD symptom severity score of 17 based on the Yale Brown Obsessive Compulsive Scale (YBOCS) 3. Medication for OCD will be allowed (SSRI, clomipramine, adjunctive antipsychotic) as long as the formulation and dose remains unchanged for 16 weeks before the study and for the total duration of the study 4. Have a use of a smartphone but patients without easy access to it will be provided with a mobile device that runs the app 5. Aged 18 to 65 years old 6. Adequate use of English to understand the study documentation and participate in the rating assessments 7. Capable of giving consent
Exclusion criteria
Exclusion criteria: 1. Severe Major Depressive Disorder with a score of at least 35 as measured by the Montgomery-Asberg Depression rating Scale (MADRS) 2. Severe suicidal ideation with a score of 4 or greater on the MADRS 3. Past or present psychotic episodes 4. Meets DSM-V criteria for substance abuse or dependence 5. Severe physical impairments affecting eyesight or motor performance, as this may affect performance on behavioural tasks 6. Any changes in dosage or formulation of medication known to be efficacious in OCD in the previous 16 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Presence of OCD measured using the Yale Brown Obsessive Compulsive Symptom (YBOCS) Checklist at baseline screening and again at end of study at 12 weeks. 2. OCD symptoms measured using Yale Brown Obsessive Compulsive Scale (YBOCS) at baseline (Week0), midpoint (week6) and at study end (end of the 12 sessions treatment programme) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The MINI International Neuropsychiatric Interview (M.I.N.I.) questionnaire at baseline used both for inclusion purposes to confirm the diagnosis for OCD and for exclusion purposes to screen for Major Depressive Disorder (MDD), Alcohol and Substance Misuse and Psychotic Disorders. 2. National Adult Reading Test (NART) to measure verbal intelligence. It is simply a measure of scholarity at baseline 3. Edinburgh Handedness Inventory (EHI) to measure a person's right or left hand dominance in everyday activities at baseline 4. MADRS for measuring the severity of depressive symptoms at baseline, at 6 weeks and at 12 weeks 5. Sheehan Disability Scale (SDS) to evaluate the impact of the patient’s symptoms/illness on three areas of functioning: work, social and family at 6 weeks and at 12 weeks. 6. State/Trait Anxiety Questionnaire (STAI) to report the anxiety feelings currently experienced by the participant at the present moment at baseline, at 6 weeks and at 12 weeks 7. Self Report Habit Index (SRHI) for measuring habit strength and automaticity at baseline, 6 weeks and at 12 weeks. 8. Intolerance of Uncertainty Scale measures the unpleasantness of uncertainty at 6 weeks and at 12 weeks 9. The Intradimensional / Extradimensional Shift task (IED) (CANTAB) measuring the participant’s ability to withhold/sustain their attention to certain rules displayed on a computer screen at baseline, at 6 weeks and at 12 weeks 10. Electroencephalography (EEG) analyses to record electrical activity in the brain at baseline, 6 weeks and at 12 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed