Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT03215134
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Registered with and opt into the Southwark IAPT service, Talking Therapies Southwark
3. Score at least 10 on the WSAS questionnaire regarding the impact of self-criticism on their daily life
4. Requesting help for their self-criticism.
Exclusion Criteria:
1. Not being sufficiently proficient in English to fully participate in the sessions with English-speaking therapists or process the written study materials for any reason.
2. Being unable to attend six sessions of assessment/treatment.
3. Presenting with high levels of risk requiring monitoring and assistance beyond the weekly intervention focusing on self-criticism.
4. Current serious mental health problem such as bipolar disorder, anorexia nervosa or a moderate / severe substance use disorder.
5. Cognitive impairment or psychomotor retardation of a degree that would prevent completion of the study treatment protocol with the individual. This would be based on a clinical judgement by potential referrers or by the clinician undertaking the screening assessment.
6. Currently experiencing a degree of life stress (e.g. recent bereavement) that is judged by the assessor to be likely to seriously adversely affect their ability to benefit from the intervention
7. New pharmacological interventions for psychological distress - i.e. a change of medication or dosage in the last 4 weeks.
8. Current participation in another clinical (talking therapy or drug) trial or another psychological intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03215134
Study Brief:
Protocol Section:
NCT03215134