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The Session Wants and Need Outcome Measure: The Development of a Brief Outcome Measure for Single-Sessions of Web-Based Support

ABSTRACT: Single-session, brief interventions in therapy for young people make up a large proportion of service provision, including in digital mental health settings. Current nomothetic mental health measures are not specifically designed to capture the benefit or ‘change’ directly related to these brief interventions. As a consequence, we set out to design an outcome measure to concretely demonstrate the value of single-session interventions. The Session Wants and Needs Outcome Measure (SWAN-OM) aims to capture in-session goals and focuses on being user-centric, elements critical to the success of single-session and brief interventions which typically are asset-based and solution-focused. We describe the 4-stage process that was followed to develop this measure: (I) classical item generation and development, (II) content and (III) face validity pilot testing, and (IV) a user-experience approach with young people using framework analysis. This final stage was critical to ensure the integration of this outcome tool into a web-based digital therapy setting, a context which adds another layer of design complexity to item and measure development. This iterative methodology was used to overcome the challenges encountered and to place the needs of the young people and service practitioners at the centre of the design process, thus ensuring measure usability. To end, we highlight the main lessons learnt from engaging in this design process. Specifically, the needs of a measure for single-session interventions are considered, before outlining the learning associated with integrating the measure into a digital mental health platform. Both of these areas are emerging fields and, as such, this study contributes to our understanding of how an idiographic patient outcome theory driven measure can be created for use in a web-based digital mental health therapy service.

SUBMITTER: de Ossorno Garcia S

PROVIDER: S-EPMC8588807 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceChronic low back pain (CLBP), the most prevalent chronic pain condition, imparts substantial disability and discomfort. Cognitive behavioral therapy (CBT) reduces the effect of CLBP, but access is limited.ObjectiveTo determine whether a single class in evidence-based pain management skills (empowered relief) is noninferior to 8-session CBT and superior to health education at 3 months after treatment for improving pain catastrophizing, pain intensity, pain interference, and other secondary outcomes.Design, setting, and participantsThis 3-arm randomized clinical trial collected data from May 24, 2017, to March 3, 2020. Participants included individuals in the community with self-reported CLBP for 6 months or more and an average pain intensity of at least 4 (range, 0-10, with 10 indicating worst pain imaginable). Data were analyzed using intention-to-treat and per-protocol approaches.InterventionsParticipants were randomized to (1) empowered relief, (2) health education (matched to empowered relief for duration and format), or (3) 8-session CBT. Self-reported data were collected at baseline, before treatment, and at posttreatment months 1, 2, and 3.Main outcomes and measuresGroup differences in Pain Catastrophizing Scale scores and secondary outcomes at month 3 after treatment. Pain intensity and pain interference were priority secondary outcomes.ResultsA total of 263 participants were included in the analysis (131 women [49.8%], 130 men [49.4%], and 2 other [0.8%]; mean [SD] age, 47.9 [13.8] years) and were randomized into 3 groups: empowered relief (n = 87), CBT (n = 88), and health education (n = 88). Empowered relief was noninferior to CBT for pain catastrophizing scores at 3 months (difference from CBT, 1.39 [97.5% CI, -∞ to 4.24]). Empowered relief and CBT were superior to health education for pain catastrophizing scores (empowered relief difference from health education, -5.90 [95% CI, -8.78 to -3.01; P < .001]; CBT difference from health education, -7.29 [95% CI, -10.20 to -4.38; P < .001]). Pain catastrophizing score reductions for empowered relief and CBT at 3 months after treatment were clinically meaningful (empowered relief, -9.12 [95% CI, -11.6 to -6.67; P < .001]; CBT, -10.94 [95% CI, -13.6 to -8.32; P < .001]; health education, -4.60 [95% CI, -7.18 to -2.01; P = .001]). Between-group comparisons for pain catastrophizing at months 1 to 3 were adjusted for baseline pain catastrophizing scores and used intention-to-treat analysis. Empowered relief was noninferior to CBT for pain intensity and pain interference (priority secondary outcomes), sleep disturbance, pain bothersomeness, pain behavior, depression, and anxiety. Empowered relief was inferior to CBT for physical function.Conclusions and relevanceAmong adults with CLBP, a single-session pain management class resulted in clinically significant improvements in pain catastrophizing, pain intensity, pain interference, and other secondary outcomes that were noninferior to 8-session CBT at 3 months.Trial registrationClinicalTrials.gov Identifier: NCT03167086.

Project description:BACKGROUND:Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. OBJECTIVE:The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. METHODS:We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. RESULTS:Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). CONCLUSIONS:Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG)

Project description:BackgroundThe Common Elements Toolbox (COMET) is an unguided digital single-session intervention (SSI) based on principles of cognitive behavioral therapy and positive psychology. Although unguided digital SSIs have shown promise in the treatment of youth psychopathology, the data are more mixed regarding their efficacy in adults.ObjectiveThis study aimed to investigate the efficacy of COMET-SSI versus a waiting list control in depression and other transdiagnostic mental health outcomes for Prolific participants with a history of psychopathology.MethodsWe conducted an investigator-blinded, preregistered randomized controlled trial comparing COMET-SSI (n=409) with an 8-week waiting list control (n=419). Participants were recruited from the web-based workspace Prolific and assessed for depression, anxiety, work and social functioning, psychological well-being, and emotion regulation at baseline and at 2, 4, and 8 weeks after the intervention. The main outcomes were short-term (2 weeks) and long-term (8 weeks) changes in depression and anxiety. The secondary outcomes were the 8-week changes in work and social functioning, well-being, and emotion regulation. Analyses were conducted according to the intent-to-treat principle with imputation, without imputation, and using a per-protocol sample. In addition, we conducted sensitivity analyses to identify inattentive responders.ResultsThe sample comprised 61.9% (513/828) of women, with a mean age of 35.75 (SD 11.93) years. Most participants (732/828, 88.3%) met the criteria for screening for depression or anxiety using at least one validated screening scale. A review of the text data suggested that adherence to the COMET-SSI was near perfect, there were very few inattentive respondents, and satisfaction with the intervention was high. However, despite being powered to detect small effects, there were negligible differences between the conditions in the various outcomes at the various time points, even when focusing on subsets of individuals with more severe symptoms.ConclusionsOur results do not support the use of the COMET-SSI in adult Prolific participants. Future work should explore alternate ways of intervening with paid web-based participants, including matching individuals to SSIs they may be most responsive to.Trial registrationClinicalTrials.gov NCT05379881, https://clinicaltrials.gov/ct2/show/NCT05379881.

Project description:BackgroundFew measures capture the complex symptoms and concerns of those receiving palliative care.AimTo validate the Integrated Palliative care Outcome Scale, a measure underpinned by extensive psychometric development, by evaluating its validity, reliability and responsiveness to change.DesignConcurrent, cross-cultural validation study of the Integrated Palliative care Outcome Scale - both (1) patient self-report and (2) staff proxy-report versions. We tested construct validity (factor analysis, known-group comparisons, and correlational analysis), reliability (internal consistency, agreement, and test-retest reliability), and responsiveness (through longitudinal evaluation of change).Setting/participantsIn all, 376 adults receiving palliative care, and 161 clinicians, from a range of settings in the United Kingdom and Germany.ResultsWe confirm a three-factor structure (Physical Symptoms, Emotional Symptoms and Communication/Practical Issues). Integrated Palliative care Outcome Scale shows strong ability to distinguish between clinically relevant groups; total Integrated Palliative care Outcome Scale and Integrated Palliative care Outcome Scale subscale scores were higher - reflecting more problems - in those patients with 'unstable' or 'deteriorating' versus 'stable' Phase of Illness (F = 15.1, p < 0.001). Good convergent and discriminant validity to hypothesised items and subscales of the Edmonton Symptom Assessment System and Functional Assessment of Cancer Therapy-General is demonstrated. The Integrated Palliative care Outcome Scale shows good internal consistency (α = 0.77) and acceptable to good test-retest reliability (60% of items kw > 0.60). Longitudinal validity in form of responsiveness to change is good.ConclusionThe Integrated Palliative care Outcome Scale is a valid and reliable outcome measure, both in patient self-report and staff proxy-report versions. It can assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care. This represents a major step forward internationally for palliative care outcome measurement.

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The Session Wants and Need Outcome Measure: The Development of a Brief Outcome Measure for Single-Sessions of Web-Based Support

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