Critical consideration of assessment methods for clinically significant changes of mental distress after psycho‐oncological interventions

Vaganian, Lusine; Bussmann, Sonja; Gerlach, Alexander L.; Kusch, Michael; Labouvie, Hildegard; Cwik, Jan Christopher

doi:10.1002/mpr.1821

Cited by 18 publications

(15 citation statements)

References 36 publications

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“…Data from several studies support a minimally clinically important difference of 1.5–2. 44 , 45 The current study demonstrated an absolute improvement of 3.8 in this score, with a relative improvement of 26%. A similar relative improvement of 22% was seen in the PSS.…”

Section: Discussionsupporting

confidence: 55%

A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease

Peerani

Watt

Ismond

et al. 2022

Therap Adv Gastroenterol

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Background: Psychological stress negatively impacts inflammatory bowel disease (IBD) outcomes. Patients have prioritized access to online interventions; yet, the data on these have been limited by mixed in-person/online interventions, low adherence, and non-randomized controlled trial (RCT) design. Objectives: We assessed the efficacy of and adherence to a 12-week online multicomponent stress reduction intervention in IBD. Design: This is a RCT. Methods: Adult participants on stable IBD medical therapy with elevated stress levels from four centers were randomized to intervention or control groups. Intervention participants received a 12-week online program including a weekly yoga, breathwork and meditation video (target 2–3 times/week), a weekly cognitive behavioral therapy/positive psychology informed video activity, and weekly 10-min check-ins by a study team member. Control participants received weekly motivational messages by email. All patients received standard of care IBD therapy. The primary outcome was Cohen’s Perceived Stress Scale (PSS). Secondary outcomes evaluated mental health, resilience, health-related quality of life (HRQoL), symptom indices, acceptability, adherence, and inflammatory biomarkers. Analysis of covariance was used to determine between-group differences. Results: Of 150 screened patients, 101 were randomized to the intervention ( n = 49) and control ( n = 52) groups (mean age: 42.5 ± 14.1 years; M:F 1:3, 48% with ulcerative colitis and 52% with Crohn’s disease). The between-group PSS improved by 22.4% (95% confidence interval, 10.5–34.3, p < 0.001). Significant improvements were seen in mental health, resilience, and HRQoL measures, with a median satisfaction score of 89/100 at the end of the 12 weeks. In the 44/49 patients who completed the intervention, 91% achieved program adherence targets. Conclusion: This 12-week online intervention improved perceived stress, mental health, and HRQoL, but did not impact IBD symptom indices or inflammatory biomarkers. The program was readily adopted and adhered to by participants with high retention rates. After iterative refinement based on participant feedback, future studies will evaluate the impact of a longer/more intense intervention on disease course. Registration: ClinicalTrials.gov Identifier NCT03831750 Plain Language Summary An online stress reduction intervention in inflammatory bowel disease patients improves stress, mental health, and quality of life People with inflammatory bowel disease (IBD) have high levels of stress, anxiety, and depression. Although IBD patients have expressed the need for online mental wellness interventions, the existing data to support these interventions in IBD are limited. In this trial, 101 IBD patients had the chance to participate in a 12-week online stress reduction intervention. In those patients randomly selected to participate in the online intervention, each week they received the following: a 20- to 30-min yoga, breathwork, and meditation video that they were asked to do 2–3 times a week, a 10- to 20-min mental wellness activity they were asked to do once during the week, and a 10-min telephone check-in with a study team member. Participants who were not selected to use the online intervention received a weekly motivational message by email. In all, 90 of the 101 participants (89%) completed the study with the mean age of participants being 43 years and the majority being females (75%). Ninety-one percent of participants who completed the intervention met the program target of doing the yoga, breathwork, and meditation video at least 2 times per week. Significant improvements were seen in perceived stress (by 22.4%), depression (by 29.5%), anxiety (by 23.7%), resilience (by 10.6%), and quality of life (by 8.9%). No changes were seen in IBD severity or in blood markers of inflammation. In conclusion, this study demonstrates evidence that a 12-week online stress reduction intervention had low dropout rates, high adherence and beneficial effects on stress, mental health, and quality of life measures. Continued feedback will be sought from study participants and our IBD patient partners to refine the intervention and assess the impact in future studies of patients with active IBD, as well as the impact of a longer/more intense intervention.

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Section: Discussionsupporting

confidence: 55%

A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease

Peerani

Watt

Ismond

et al. 2022

Therap Adv Gastroenterol

View full text Add to dashboard Cite

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“…A minimal important difference (MID) for change in the hospital anxiety and depression scale score has not been determined in a population of adults with overweight and obesity. The minimal important difference in alternative populations (adults with cancer, cardiovascular disease, bronchiectasis, and chronic obstructive pulmonary disease) has most commonly been defined as a change of 2 points [ 32 , 33 , 34 , 35 , 36 ]. Therefore, we categorized changes in depression/anxiety as “decrease in symptoms” (≤−2), “no change in symptoms” (−1.99 to 1.99), or “increase in symptoms” (≥2) in the multinomial regression models.…”

Section: Methodsmentioning

confidence: 99%

Participant Characteristics Associated with Changes in Mental Health in a Trial of Behavioural Weight Management Programmes: Secondary Analysis of the WRAP Trial

et al. 2022

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Introduction: On average, aspects of mental health improve following behavioural weight management programmes, yet this is not the case for all participants. It is important to identify those at risk of harm to provide more effective psychological support. We aimed to identify participant characteristics associated with changes in depression and anxiety in participants of a behavioural weight management programme. Methods: In the Weight loss Referrals for Adults in Primary care (WRAP) trial, 1267 adults with BMI≥28 kg/m2 were randomised to brief intervention, or WW (formerly Weight Watchers) for 12-weeks or 52-weeks and followed for five years. We used linear and multinomial regression to explore the association between participant characteristics and changes in depression and anxiety (measured by Hospital Anxiety and Depression Scale). Where possible, the impact of missing data was investigated using multiple imputation. Results: Higher baseline anxiety was associated with decreases in anxiety symptoms and increases in depression symptoms from baseline to follow-up. Higher baseline depression was associated with decreases in depression symptoms and increases in anxiety symptoms from baseline to follow-up. The magnitude of the associations were small. No further characteristics were consistently associated with changes in mental health. Discussion: Evidence suggests that baseline depression and anxiety may indicate how depression and anxiety symptoms change during and after attending WW. Measurement of depression and anxiety at the start of a behavioural weight management programme and subsequent monitoring may facilitate timely psychological support if a deterioration in mental health is identified. Further research in large and diverse participant samples is required to clarify the findings.

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“…In our samples, similar internal consistencies were obtained ( α = .8479 for the anxiety and α = .824 for the depression scales). A score of 10 or more on HADS total scale resulted useful for screening significant distress in a Spanish sample, 29 and a change of ≥2 points has been used as a cut‐off point to assess the clinical change 30 …”

Section: Methodsmentioning

confidence: 99%

Video conference vs face‐to‐face group psychotherapy for distressed cancer survivors: A randomized controlled trial

et al. 2020

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Objective: This study assesses the effectiveness of face-to-face group positive psychotherapy for cancer survivors (PPC) compared to its online adaptation, online group positive psychotherapy for cancer survivors (OPPC), which is held via videoconference. A two-arm, pragmatic randomized controlled trial was conducted to examine the effects of both interventions on emotional distress, post-traumatic stress symptoms (PTSS), and post-traumatic growth (PTG) among cancer survivors and analyze attrition to treatment. Methods: Adult women with a range of cancer diagnoses were invited to participate if they experienced emotional distress at the end of their primary oncological treatment. Emotional distress, PTSS, and PTG were assessed at baseline, immediately after treatment, and 3 months after treatment. Intention-to-treat analyses were carried out using general linear mixed models to test the effect of the interventions overtime. Logistic regressions were performed to test differential adherence to treatment and retention to follow-up. Results: A total of 269 individuals participated. The observed treatment effect was significant in both modalities, PPC and OPPC. Emotional distress (b = −2.24, 95% confidence interval [CI] = −3.15 to −1.33) and PTSS (b = −3.25, 95% CI = −4.97 to −1.53) decreased significantly over time, and PTG (b = 3.08, 95% CI = 0.38-5.78) increased significantly. Treatment gains were sustained across outcomes and over time. Analyses revealed no significant differences between modalities of treatment, after adjusting for baseline differences, finding that OPPC is as effective and engaging as PPC. Conclusions: The OPPC treatment was found to be effective and engaging for female cancer early survivors. These results open the door for psycho-oncology interventions via videoconference, which are likely to lead to greater accessibility and availability of psychotherapy.

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Critical consideration of assessment methods for clinically significant changes of mental distress after psycho‐oncological interventions

Cited by 18 publications

References 36 publications

A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease

A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease

Participant Characteristics Associated with Changes in Mental Health in a Trial of Behavioural Weight Management Programmes: Secondary Analysis of the WRAP Trial

Video conference vs face‐to‐face group psychotherapy for distressed cancer survivors: A randomized controlled trial

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