NCT04978792

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

  1. 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. 2.Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism?
  3. 3.Are changes in state and/or trait self-compassion associated with improvements in mental health?
  4. 4.Are changes in mental health mediated by changes in self-criticism or perceived criticism?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 9, 2021

Last Update Submit

July 27, 2022

Conditions

Keywords

self-compassioncriticismADHDmental health

Outcome Measures

Primary Outcomes (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Fear of compassion

    Baseline

  • Acceptability of the Intervention

    Immediately following intervention end

  • Change in daily Mood

    Prior to each intervention session

  • Change in ADHD trait severity

    Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.

  • Perfectionism

    Baseline.

Study Arms (2)

Self-compassion Intervention

EXPERIMENTAL

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.

Behavioral: Online self-compassion intervention

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Active Control

Interventions

An online self-guided intervention that uses widely available exercises and information.

Self-compassion Intervention
Active ControlBEHAVIORAL

Participants will complete written exercises and breathing exercises that are not associated with self-compassion

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Sheffield

Sheffield, South Yorkshire, S10 2TN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 27, 2021

Study Start

September 23, 2021

Primary Completion

April 25, 2022

Study Completion

September 1, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
When study results are accepted for publication.

Locations