Self-Criticism Feasibility Study

Self-Criticism Clinical Trial

Official title:

A Novel Intervention for Self-criticism in a Primary Care Psychological Therapies Service: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215134
• Other study ID #: 17/LO/0335
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: December 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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; and a preliminary indication of the the effectiveness of this intervention?

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The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 12, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self-Criticism

Intervention

Other:
• Self-criticism intervention
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.

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Foundation Trust (SlaM) and Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London (KCL)	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Compassion Scale	Process measure reflecting levels of self-compassion. Change is being assessed.	Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Other	Beliefs about Emotion Scale	Process measure reflecting the acceptability of negative emotions. Change is being assessed.	Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Primary	Do clients find the intervention an acceptable treatment option	This will be assessed through anonymised written feedback	3.5 months (from start to end of therapy, including follow-up)
Primary	Is this intervention feasible to deliver within an IAPT service	This will be assessed through recruitment and retention rates	9 months - through recruitment until the end of therapy for the final participant.
Primary	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.	Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Primary	Self-Critical Rumination Scale (SCRS)	Measure of self-criticism. Change is being assessed.	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	Patient Health Questionnaire (PHQ-9)	Depressive symptoms scale. Change is being assessed.	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	Generalised Anxiety Disorder scale (GAD-7)	Anxiety related symptoms scale. Change is being assessed.	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	Rosenberg Self-Esteem Scale	Measure of self-esteem. Change is being assessed.	Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Secondary	Habitual Index of Negative Thinking	Measure of negative self-thinking. Change is being assessed.	Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.
Secondary	Forms of Self-Criticising/Attacking and Self-Reassuring Scale	measure of criticism. Change is being assessed.	Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.

External Links

•   Gilbert, P. (2010). An introduction to compassion focused therapy in cognitive behavior therapy. International Journal of Cognitive Therapy, 3, 97-112.