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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04978792
Other study ID # 172839
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 23, 2021
Est. completion date September 2022

Study information

Verified date July 2022
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 1. Does a short self-guided self-compassion intervention increase levels of state and/or trait self-compassion in adults with ADHD over time? 2. Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism? 3. Are changes in state and/or trait self-compassion associated with improvements in mental health? 4. Are changes in mental health mediated by changes in self-criticism or perceived criticism?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 114
Est. completion date September 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Online self-compassion intervention
An online self-guided intervention that uses widely available exercises and information.
Active Control
Participants will complete written exercises and breathing exercises that are not associated with self-compassion

Locations

Country Name City State
United Kingdom The University of Sheffield Sheffield South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. 4x a week after intervention exercise complete.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Primary 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. Baseline.
Primary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Secondary 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. Baseline
Secondary 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. Immediately following intervention end
Secondary 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. Prior to each intervention session
Secondary 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. Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Secondary 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. Baseline.
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