Self-Criticism Feasibility Study (NCT03215134) | Clinical Trial Compass
CompletedNot Applicable
Self-Criticism Feasibility Study
United Kingdom20 participantsStarted 2017-05-04
Plain-language summary
This uncontrolled pilot seeks to develop a novel intervention based on Compassion Focused Therapy (CFT), that reduces self-criticism and improves psychological wellbeing. The researchers aim to assess the the acceptability and feasibility of providing such an intervention within a primary mental health care service; and a preliminary indication of the the effectiveness of this intervention?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent
. Registered with and opt into the Southwark IAPT service, Talking Therapies Southwark
. Score at least 10 on the WSAS questionnaire regarding the impact of self-criticism on their daily life
. Requesting help for their self-criticism.
Exclusion criteria
. 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.
. Being unable to attend six sessions of assessment/treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Do clients find the intervention an acceptable treatment option
Timeframe: 3.5 months (from start to end of therapy, including follow-up)
2
Is this intervention feasible to deliver within an IAPT service
Timeframe: 9 months - through recruitment until the end of therapy for the final participant.
3
Work and Social Adjustment Scale (W&SAS) adapted to reflect self-criticism
Timeframe: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
4
Self-Critical Rumination Scale (SCRS)
Timeframe: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
. Presenting with high levels of risk requiring monitoring and assistance beyond the weekly intervention focusing on self-criticism.
. Current serious mental health problem such as bipolar disorder, anorexia nervosa or a moderate / severe substance use disorder.
. 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.
. 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
. New pharmacological interventions for psychological distress - i.e. a change of medication or dosage in the last 4 weeks.
. Current participation in another clinical (talking therapy or drug) trial or another psychological intervention.