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Completed

NCT Number: NCT03215134

Self-Criticism 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?

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Key information

Conditions

Self-Criticism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

    Depressive symptoms scale. Change is being assessed.

  2. 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.

    Anxiety related symptoms scale. Change is being assessed.

  3. Rosenberg Self-Esteem Scale

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

    Measure of self-esteem. Change is being assessed.

  4. 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.

    Measure of negative self-thinking. Change is being assessed.

  5. 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.

    measure of criticism. Change is being assessed.

Other outcomes

  1. Self-Compassion Scale

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

    Process measure reflecting levels of self-compassion. Change is being assessed.

  2. Beliefs about Emotion Scale

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

    Process measure reflecting the acceptability of negative emotions. Change is being assessed.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • South London and Maudsley NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2017
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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