Self-Criticism Feasibility Study

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?

Study Overview

• Status: Completed
• Conditions: Self-Criticism
• Intervention / Treatment: Other: Self-criticism 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The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism.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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • South London and Maudsley NHS Foundation Trust (SlaM) and Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London (KCL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Self-criticism intervention; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: South London and Maudsley NHS Foundation Trust
• Investigators: Principal Investigator: Mehul Elliott-Joshi, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), Kings College London; South London and Maudsley (SLaM) NHS Foundation Trust

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2017
• Primary Completion (ACTUAL): April 20, 2018
• Study Completion (ACTUAL): June 12, 2018

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (ACTUAL): July 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Improving Access to Psychological Therapies (IAPT); Primary mental health service; Compassion Focused Therapy (CFT)
• Other Study ID Numbers: 17/LO/0335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No