Self-CriticismNCT03215134
Self-Criticism Feasibility Study
A study testing Self-criticism intervention in people with Self-Criticism, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-Criticism
- What is being tested?
- Self-criticism intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2017to 12 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust (SlaM) and Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London (KCL)
London, SE5 8AF
About this study
Official title: A Novel Intervention for Self-criticism in a Primary Care Psychological Therapies Service: Feasibility Study
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?
Read the detailed description
The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism. This pilot study aims to adapt the intervention for an Improving Access to Psychological Therapies (IAPT) service, a primary mental-health service in the UK.
Self-criticism is a transdiagnostic process across common mental-health disorders and is therefore, a potential target for psychological intervention. Clients at IAPT are likely to present with high levels of self-criticism. This pilot study may help develop an alternative evidence-based intervention that can be routinely offered within IAPT services.
The researchers aim to recruit 20 clients registered at Talking Therapies Southwark, experiencing a significant impact of self-criticism on their daily life, and requesting help for self-criticism. Clients that provide consent to participate in this study would receive 6 sessions of this intervention and a 2-month follow-up telephone session.
- Conditions
- Self-Criticism
- Being tested
- Self-criticism intervention
- Keywords
- Improving Access to Psychological Therapies (IAPT), Primary mental health service, Compassion Focused Therapy (CFT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-criticism interventionOther
Compassion Focused Therapy (Gilbert, 2010) adapted to focus specifically on reducing self-criticism. This intervention was originally developed for a student population (Rose, McIntyre \& Rimes, submitted) and is now being evaluated in a primary mental-health service.
| Study group | Role | What they receive |
|---|---|---|
| Self-criticism intervention | Experimental | 6 weekly face to face therapy sessions (1st assessment an intervention session of 60 to 90 minutes; sessions 2-5 are 60 minutes each) and a 2 month follow-up telephone call of upto 30 minutes. Receives: Other: Self-criticism intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Do clients find the intervention an acceptable treatment option
This will be assessed through anonymised written feedback
Measured: 3.5 months (from start to end of therapy, including follow-up)
Is this intervention feasible to deliver within an IAPT service
This will be assessed through recruitment and retention rates
Measured: 9 months - through recruitment until the end of therapy for the final participant.
Work and Social Adjustment Scale (W&SAS) adapted to reflect self-criticism
Measure of the impact of the presenting problem, in this case, self-criticism. Change is being assessed.
Measured: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Self-Critical Rumination Scale (SCRS)
Measure of self-criticism. Change is being assessed.
Measured: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Secondary outcomes (5)
Patient Health Questionnaire (PHQ-9)
Depressive symptoms scale. Change is being assessed.
Measured: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Generalised Anxiety Disorder scale (GAD-7)
Anxiety related symptoms scale. Change is being assessed.
Measured: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Rosenberg Self-Esteem Scale
Measure of self-esteem. Change is being assessed.
Measured: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Habitual Index of Negative Thinking
Measure of negative self-thinking. Change is being assessed.
Measured: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Forms of Self-Criticising/Attacking and Self-Reassuring Scale
measure of criticism. Change is being assessed.
Measured: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start4 May 2017
- Primary completion20 Apr 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-CriticismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- uncontrolled pilot study of 1 intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Mehul Elliott-Joshi, Principal investigator, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), Kings College London; South London and Maudsley (SLaM) NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215134
- Sponsor's protocol ID
- 17/LO/0335
- Status last verified
- Dec 2017
- First submitted
- 6 Jun 2017
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention for Self-criticism in a Primary Care Psychological Therapies Service: Feasibility Study
- ClinicalTrials.gov ID
- NCT03215134
- Acronym / sponsor ID
- 17/LO/0335
- Conditions
- Self-Criticism
- Keywords
- Improving Access to Psychological Therapies (IAPT), Primary mental health service, Compassion Focused Therapy (CFT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 4 May 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism. This pilot study aims to adapt the intervention for an Improving Access to Psychological Therapies (IAPT) service, a primary mental-health service in the UK.
Self-criticism is a transdiagnostic process across common mental-health disorders and is therefore, a potential target for psychological intervention. Clients at IAPT are likely to present with high levels of self-criticism. This pilot study may help develop an alternative evidence-based intervention that can be routinely offered within IAPT services.
The researchers aim to recruit 20 clients registered at Talking Therapies Southwark, experiencing a significant impact of self-criticism on their daily life, and requesting help for self-criticism. Clients that provide consent to participate in this study would receive 6 sessions of this intervention and a 2-month follow-up telephone session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- uncontrolled pilot study of 1 intervention
| Arm | Type | Receives |
|---|---|---|
| Self-criticism intervention | Experimental | Other: Self-criticism intervention6 weekly face to face therapy sessions (1st assessment an intervention session of 60 to 90 minutes; sessions 2-5 are 60 minutes each) and a 2 month follow-up telephone call of upto 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-criticism interventionCompassion Focused Therapy (Gilbert, 2010) adapted to focus specifically on reducing self-criticism. This intervention was originally developed for a student population (Rose, McIntyre \& Rimes, submitted) and is now being evaluated in a primary mental-health service. | Other | Self-criticism intervention |
Primary outcome
Do clients find the intervention an acceptable treatment option
Time frame: 3.5 months (from start to end of therapy, including follow-up)
This will be assessed through anonymised written feedback
Is this intervention feasible to deliver within an IAPT service
Time frame: 9 months - through recruitment until the end of therapy for the final participant.
This will be assessed through recruitment and retention rates
Work and Social Adjustment Scale (W&SAS) adapted to reflect self-criticism
Time frame: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Measure of the impact of the presenting problem, in this case, self-criticism. Change is being assessed.
Self-Critical Rumination Scale (SCRS)
Time frame: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Measure of self-criticism. Change is being assessed.
5 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Generalised Anxiety Disorder scale (GAD-7)
Time frame: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Rosenberg Self-Esteem Scale
Time frame: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Habitual Index of Negative Thinking
Time frame: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Forms of Self-Criticising/Attacking and Self-Reassuring Scale
Time frame: Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Self-Criticism
Recruiting
Readiness and Progress in Emotion Regulation Therapy
Rumination, Worry
Recruiting
Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion
Post-traumatic Stress Disorder (PTSD)
Recruiting
Brief Interventions for Coping with Distress
Distress, Emotional, Emotional Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehul Elliott-Joshi principal investigator
Institute of Psychiatry, Psychology and Neuroscience (IoPPN), Kings College London; South London and Maudsley (SLaM) NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-criticism intervention in people with Self-Criticism, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Do clients find the intervention an acceptable treatment option (time frame: 3.5 months (from start to end of therapy, including follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.