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Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?

Primary Purpose

ADHD, Depression, Stress

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online self-compassion intervention
Active Control
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring self-compassion, criticism, ADHD, mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Self-report a formal diagnosis of ADHD
  • Scores on the Adult ADHD Self Report Questionnaire (ASRS) meet the clinical cut-off.
  • No previous engagement with self-compassion interventions/practice

Exclusion Criteria:

  • No previous experiences of trauma.
  • No PTSD
  • No personality disorder

Sites / Locations

  • The University of Sheffield

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-compassion Intervention

Control Group

Arm Description

The intervention will include 14 self-compassion exercises completed over a 3-week period. The intervention will include methods of psychoeducation, meditation, and self-compassion exercises similar to Beshai et al.'s (2020) self-compassion-based intervention. The psychoeducation will focus on self-compassion, the meditations will be kindness and loving meditations and self-compassion breaks. The self-compassion exercises will be based on the writing exercises available on Neff's self-compassion website.

The active control will also include 14 exercises completed over a 3-week period. The 14 exercises will comprise of a psychoeducation video, writing exercises, video/audio-guided relaxation, and journal entries. The same psychoeducation video used in the intervention will be shown to participants, however, the other exercises will be altered to focus on factual information and not focused on self-compassion. The exercises will be matched to the self-compassion exercise so that similar exercises are completed in parallel time with the intervention.

Outcomes

Primary Outcome Measures

Change in trait Self-compassion
The self-compassion scale (SCS, Neff, 2003) consists of 26 items measured on a scale between 1-5 (never - always). The items include 3 sub-scales that represent compassionate self-responding (self-kindness, mindfulness and common humanity) and 3 sub-scales of uncompassionate self-responding (self-judgement, isolation and over-identification). To obtain a total self-compassion score, the uncompassionate items are reverse coded, the mean score for each subscale is calculated, then the mean of the six subscale scores added together is calculated. The mean scores can range between 1 - 5, whereby higher scores indicate higher self-compassion
Change in state self-compassion
The State Self-Compassion Scale Short Form (SSCS-S; (Neff et al., 2021) is a six-item measure of state self-compassion. The six items are rated on a 5-point scale from 1 (not at all true for me) to 5 (very true for me), and responses are summed (after negatively worded questions are reverse coded) to provide a global state self-compassion measure. Higher scores equate to higher levels of state self-compassion.
Change in Perceived Criticism
An adapted version of The Perceived Criticism Scale (PCS) (Hooley & Teasdale, 1989) will be used to measure how much criticism is "getting through" to individuals. The measure is a single question, "How critical do you think people in your nearest environment - such as family, friends, colleagues - are of you?", that is rated between 0 (not at all critical of me) to 10 (very critical of me). The measure can also include a second item also rated on a 1-10 scale that asks how upset the respondent may become when criticised.
Change in wellbeing
The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2009) will be used to measure the frequency of well-being symptoms (never [0] - every day [5]). The self-report questionnaire includes 14-items that measure emotional well-being (3-items), psychological well-being (6-items) and social well-being (5-items). A global well-being score between 0 - 70 is achieved by summing the scores for each item, whereby higher scores equal greater well-being. Subscale scores are calculated by summing the responses for each item of the corresponding sub-scale; emotional well-being scores can range between 0 - 15, social well-being scores can range between 0 - 25, and psychological well-being scores can range between 0 - 30.
Change in Depression
The Patient Health Questionnaire - 9 (PHQ-9) (Kroenke et al., 2001) will be used to assess the severity of depressive symptoms and assess responses to treatment. The PHQ-9 has nine items that represent each of the DSM-IV (APA) criteria of depression. The items, such as "feeling down, depressed, or hopeless?", are rated on a scale of 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score is calculated by summing the scores for each item, providing a severity score between 0 and 27. Higher scores represent more severe depression, and scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe and severe depression, respectively.
Change in Anxiety
General Anxiety Disorder- 7 (GAD-7) (Spitzer et al., 2006) will be used to assess the severity of anxiety. The GAD-7 includes 7 items that represent the DSM-IV (APA) clinical criteria. The items, such as "becoming easily annoyed or irritable", are scored on a scale between 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score between 0 - 21 is calculated by summing each individual item's rating. Higher scores represent more severe anxiety, and scores of 5, 10 and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Change in Stress
The Perceived Stress Scale (PSS, Cohen et al., 1983) will be used to measure participant's perception of stress. The 10-item self-report questionnaire includes four positively worded items and six negatively worded items that are rated on how frequently (never [0] - very often [4]) respondents perceive their lives as unpredictable, uncontrollable or overwhelming. Positively worded items are reverse scored, and each item response is summed to provide a total score of between 0 - 40 whereby higher scores equal higher perceived stress.
ADHD severity
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a screening tool to assess the frequency of ADHD symptoms and as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). Part A is a 6-item questionnaire that assesses the frequency to which ADHD symptoms are present on a 5-point Likert Scale (Never - Always). It is recommended that individuals who report "sometimes", "often" or "very often" to the first three questions, or "often", "very often" to the final three questions four or more items, have symptoms highly consistent with ADHD.
Changes in self-criticism
The Self-Critical Rumination Scale (SCRS, Smart et al., 2016) is a 10-item self-report questionnaire which measures the frequency of self-criticism on a 4-point scale from not at all (0) to very well (3). Self-criticism in this measure is conceptualised as a form of negative thinking that focuses on devaluing oneself. A total score is obtained by summing item responses, whereby higher scores equal greater self-criticism. Scores can range between 0 - 30.

Secondary Outcome Measures

Fear of compassion
The Fears of Compassion for Self (FOC-FS) (Gilbert et al., 2011) subscale will measure the level of resistance respondents have in projecting compassion towards the self. The measure includes 15 items (e.g., "Getting on in life is about being tough rather than compassionate") that are rated on a scale between 0 (don't agree at all) ¬- 4 (completely agree). Item responses are summed to give a total score between 0 and 60 whereby higher scores indicate a greater fear of compassion towards the self.
Acceptability of the Intervention
Acceptability of the intervention at post-intervention will be assessed following Sekhon et al.'s (2017) Theoretical Framework of Acceptability (TFA). A visual analogue rating scale will be used to measure: (1) affective attitude - how do you feel about the intervention?; (2) burden - how satisfied were you with the amount of time/effort the intervention required?; (3) ethicality - how well do you feel the intervention fits with your value system?; (4) self-efficacy - how confident are you that you could perform the intervention tasks?; (5) opportunity costs - to what extent did you have to give up something to take part in the intervention?; (6) perceived effectiveness - how confident are you that this intervention will improve your well-being?; (7) intervention coherence will be measured through a basic definitions quiz of self-compassion principles.
Change in daily Mood
Mood will be measured daily using two affective sliders that rate level of alertness and level of happiness/pleasure on a 10-point scale. The two item responses are added together to give an overall score of mood between 0 and 20, whereby higher scores equal a more positive mood.
Change in ADHD trait severity
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). It consists of 18 items that question the frequency of ADHD symptoms from "never" to "very often" (0 - 4) over the previous 6 months. Part A consists of 6-items that are most predictive of the disorder. Part B includes an additional 12 items which act as additional cues to participants symptoms. A total score can be obtained by summing the scores. A higher total score would represent a more frequent display of ADHD symptoms, and scores can range between 0 - 72.
Perfectionism
Hewitt & Flett Multidimensional Perfectionism Scale (MPS-HW) Short form (2008), is a 15 item self-report questionnaire. Items are rated on a scale between 1-7 (Strongly disagree - strongly disagree), and is scored by summing responses to items. Higher scores indicate higher levels of perfectionism. Scores can range between 15 and 105.

Full Information

First Posted
July 9, 2021
Last Updated
July 27, 2022
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT04978792
Brief Title
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
Official Title
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the effect that increasing levels of self-compassion may have on levels of perceived criticism, self-criticism, and mental health of adults with ADHD. A secondary aim of the study is to capture how feasible using an online self-guided self-compassion practice maybe with people with ADHD. Research Questions Does a short self-guided self-compassion intervention increase levels of state and/or trait self-compassion in adults with ADHD over time? Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism? Are changes in state and/or trait self-compassion associated with improvements in mental health? Are changes in mental health mediated by changes in self-criticism or perceived criticism?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Depression, Stress, Self-Criticism, Anxiety, Wellbeing, Self-compassion
Keywords
self-compassion, criticism, ADHD, mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-compassion Intervention
Arm Type
Experimental
Arm Description
The intervention will include 14 self-compassion exercises completed over a 3-week period. The intervention will include methods of psychoeducation, meditation, and self-compassion exercises similar to Beshai et al.'s (2020) self-compassion-based intervention. The psychoeducation will focus on self-compassion, the meditations will be kindness and loving meditations and self-compassion breaks. The self-compassion exercises will be based on the writing exercises available on Neff's self-compassion website.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The active control will also include 14 exercises completed over a 3-week period. The 14 exercises will comprise of a psychoeducation video, writing exercises, video/audio-guided relaxation, and journal entries. The same psychoeducation video used in the intervention will be shown to participants, however, the other exercises will be altered to focus on factual information and not focused on self-compassion. The exercises will be matched to the self-compassion exercise so that similar exercises are completed in parallel time with the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Online self-compassion intervention
Intervention Description
An online self-guided intervention that uses widely available exercises and information.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants will complete written exercises and breathing exercises that are not associated with self-compassion
Primary Outcome Measure Information:
Title
Change in trait Self-compassion
Description
The self-compassion scale (SCS, Neff, 2003) consists of 26 items measured on a scale between 1-5 (never - always). The items include 3 sub-scales that represent compassionate self-responding (self-kindness, mindfulness and common humanity) and 3 sub-scales of uncompassionate self-responding (self-judgement, isolation and over-identification). To obtain a total self-compassion score, the uncompassionate items are reverse coded, the mean score for each subscale is calculated, then the mean of the six subscale scores added together is calculated. The mean scores can range between 1 - 5, whereby higher scores indicate higher self-compassion
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Change in state self-compassion
Description
The State Self-Compassion Scale Short Form (SSCS-S; (Neff et al., 2021) is a six-item measure of state self-compassion. The six items are rated on a 5-point scale from 1 (not at all true for me) to 5 (very true for me), and responses are summed (after negatively worded questions are reverse coded) to provide a global state self-compassion measure. Higher scores equate to higher levels of state self-compassion.
Time Frame
4x a week after intervention exercise complete.
Title
Change in Perceived Criticism
Description
An adapted version of The Perceived Criticism Scale (PCS) (Hooley & Teasdale, 1989) will be used to measure how much criticism is "getting through" to individuals. The measure is a single question, "How critical do you think people in your nearest environment - such as family, friends, colleagues - are of you?", that is rated between 0 (not at all critical of me) to 10 (very critical of me). The measure can also include a second item also rated on a 1-10 scale that asks how upset the respondent may become when criticised.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Change in wellbeing
Description
The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2009) will be used to measure the frequency of well-being symptoms (never [0] - every day [5]). The self-report questionnaire includes 14-items that measure emotional well-being (3-items), psychological well-being (6-items) and social well-being (5-items). A global well-being score between 0 - 70 is achieved by summing the scores for each item, whereby higher scores equal greater well-being. Subscale scores are calculated by summing the responses for each item of the corresponding sub-scale; emotional well-being scores can range between 0 - 15, social well-being scores can range between 0 - 25, and psychological well-being scores can range between 0 - 30.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Change in Depression
Description
The Patient Health Questionnaire - 9 (PHQ-9) (Kroenke et al., 2001) will be used to assess the severity of depressive symptoms and assess responses to treatment. The PHQ-9 has nine items that represent each of the DSM-IV (APA) criteria of depression. The items, such as "feeling down, depressed, or hopeless?", are rated on a scale of 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score is calculated by summing the scores for each item, providing a severity score between 0 and 27. Higher scores represent more severe depression, and scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe and severe depression, respectively.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Change in Anxiety
Description
General Anxiety Disorder- 7 (GAD-7) (Spitzer et al., 2006) will be used to assess the severity of anxiety. The GAD-7 includes 7 items that represent the DSM-IV (APA) clinical criteria. The items, such as "becoming easily annoyed or irritable", are scored on a scale between 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score between 0 - 21 is calculated by summing each individual item's rating. Higher scores represent more severe anxiety, and scores of 5, 10 and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Change in Stress
Description
The Perceived Stress Scale (PSS, Cohen et al., 1983) will be used to measure participant's perception of stress. The 10-item self-report questionnaire includes four positively worded items and six negatively worded items that are rated on how frequently (never [0] - very often [4]) respondents perceive their lives as unpredictable, uncontrollable or overwhelming. Positively worded items are reverse scored, and each item response is summed to provide a total score of between 0 - 40 whereby higher scores equal higher perceived stress.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
ADHD severity
Description
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a screening tool to assess the frequency of ADHD symptoms and as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). Part A is a 6-item questionnaire that assesses the frequency to which ADHD symptoms are present on a 5-point Likert Scale (Never - Always). It is recommended that individuals who report "sometimes", "often" or "very often" to the first three questions, or "often", "very often" to the final three questions four or more items, have symptoms highly consistent with ADHD.
Time Frame
Baseline.
Title
Changes in self-criticism
Description
The Self-Critical Rumination Scale (SCRS, Smart et al., 2016) is a 10-item self-report questionnaire which measures the frequency of self-criticism on a 4-point scale from not at all (0) to very well (3). Self-criticism in this measure is conceptualised as a form of negative thinking that focuses on devaluing oneself. A total score is obtained by summing item responses, whereby higher scores equal greater self-criticism. Scores can range between 0 - 30.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Secondary Outcome Measure Information:
Title
Fear of compassion
Description
The Fears of Compassion for Self (FOC-FS) (Gilbert et al., 2011) subscale will measure the level of resistance respondents have in projecting compassion towards the self. The measure includes 15 items (e.g., "Getting on in life is about being tough rather than compassionate") that are rated on a scale between 0 (don't agree at all) ¬- 4 (completely agree). Item responses are summed to give a total score between 0 and 60 whereby higher scores indicate a greater fear of compassion towards the self.
Time Frame
Baseline
Title
Acceptability of the Intervention
Description
Acceptability of the intervention at post-intervention will be assessed following Sekhon et al.'s (2017) Theoretical Framework of Acceptability (TFA). A visual analogue rating scale will be used to measure: (1) affective attitude - how do you feel about the intervention?; (2) burden - how satisfied were you with the amount of time/effort the intervention required?; (3) ethicality - how well do you feel the intervention fits with your value system?; (4) self-efficacy - how confident are you that you could perform the intervention tasks?; (5) opportunity costs - to what extent did you have to give up something to take part in the intervention?; (6) perceived effectiveness - how confident are you that this intervention will improve your well-being?; (7) intervention coherence will be measured through a basic definitions quiz of self-compassion principles.
Time Frame
Immediately following intervention end
Title
Change in daily Mood
Description
Mood will be measured daily using two affective sliders that rate level of alertness and level of happiness/pleasure on a 10-point scale. The two item responses are added together to give an overall score of mood between 0 and 20, whereby higher scores equal a more positive mood.
Time Frame
Prior to each intervention session
Title
Change in ADHD trait severity
Description
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). It consists of 18 items that question the frequency of ADHD symptoms from "never" to "very often" (0 - 4) over the previous 6 months. Part A consists of 6-items that are most predictive of the disorder. Part B includes an additional 12 items which act as additional cues to participants symptoms. A total score can be obtained by summing the scores. A higher total score would represent a more frequent display of ADHD symptoms, and scores can range between 0 - 72.
Time Frame
Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Title
Perfectionism
Description
Hewitt & Flett Multidimensional Perfectionism Scale (MPS-HW) Short form (2008), is a 15 item self-report questionnaire. Items are rated on a scale between 1-7 (Strongly disagree - strongly disagree), and is scored by summing responses to items. Higher scores indicate higher levels of perfectionism. Scores can range between 15 and 105.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-report a formal diagnosis of ADHD Scores on the Adult ADHD Self Report Questionnaire (ASRS) meet the clinical cut-off. No previous engagement with self-compassion interventions/practice Exclusion Criteria: No previous experiences of trauma. No PTSD No personality disorder
Facility Information:
Facility Name
The University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2TN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected information will be anonymised and shared as part of open science protocol. Consent to share data will be obtained from participants prior to data collection.
IPD Sharing Time Frame
When study results are accepted for publication.
Links:
URL
https://self-compassion.org/
Description
self-compassion website where intervention exercises are found.

Learn more about this trial

Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?

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