Self-Criticism Feasibility Study

NCT03215134 | Completed

• 1 other identifier: 17/LO/0335
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Self-Criticism

Keywords

Improving Access to Psychological Therapies (IAPT); Primary mental health service; Compassion Focused Therapy (CFT)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Patient Health Questionnaire (PHQ-9)

  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)

  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

  Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.

• Habitual Index of Negative Thinking

  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

  Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.

Other Outcomes (2)

• Self-Compassion Scale

  Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.

• Beliefs about Emotion Scale

  Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.

Study Arms (1)

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.

Other: Self-criticism intervention

Interventions

Self-criticism intervention OTHER

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.

Self-criticism intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust (SlaM) and Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London (KCL)

London, SE5 8AF, United Kingdom

Location

Study Officials

• Mehul Elliott-Joshi

  Institute of Psychiatry, Psychology and Neuroscience (IoPPN), Kings College London; South London and Maudsley (SLaM) NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: uncontrolled pilot study of 1 intervention

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: July 12, 2017
• Study Start: May 4, 2017
• Primary Completion: April 20, 2018
• Study Completion: June 12, 2018
• Last Updated: August 9, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)