Underlying mechanisms and efficacy of a suicide-focused psychological intervention for psychosis, the Cognitive Approaches to Combatting Suicidality (CARMS): a multicentre, assessor-masked, randomised controlled trial in the UK.
There is a need for theoretically grounded and testable suicide-focused psychological therapies, especially in people with severe mental health problems, specifically non-affective psychosis. We aimed to test both the underlying mechanisms and efficacy of a suicide-focused therapy, cognitive behavioural suicide prevention for psychosis (CBSPp).
We did a multicentre, assessor-masked, randomised controlled trial conducted at four UK National Health Service (NHS) sites. Participants were eligible for enrolment if they were 18 years or older; met ICD-10 criteria for non-affective psychosis (F20-F29); had self-reported suicidal experiences in the 3 months before recruitment; were under the care of an NHS mental health services team; were not receiving a psychological therapy as part of a similar trial; had sufficient competency in the English language not to need an interpreter to participate; and were able to give informed consent. After screening for eligibility and completion of baseline assessments, participants were randomly allocated in a 1:1 ratio to either the treatment as usual group (control) or CBSPp therapy plus standard treatment group (treatment), with stratification by use of antidepressant medication and NHS site. Randomisation took place using an online Sealed Envelope randomisation procedure conducted and overseen by the Manchester Academic Health Sciences Centre Clinical Trials Unit (MCTU). This system was accessed only by specially allocated staff (eg, the CARMS Trial Manager or the MCTU Trial manager). When the system randomly allocated a participant, an unmasked email confirmation was sent to the unmasked coprincipal investigator and the CARMS Trial Manager (also unmasked). Assessors, the trial statistician, and one coprincipal investigator were masked to allocation group. Participants were informed of their randomised allocation group by an unmasked CARMS staff member. Experts-by-experience were involved in all stages of the research. For those in the treatment group, approximately 24 one-to-one therapy sessions were offered, usually weekly, for around 50 min per session. Assessments were conducted at baseline, month 6, and month 12. The primary outcome was suicide ideation severity measured by the 25-item Adult Suicide Ideation Questionnaire (ASIQ), assessed at month 6 relative to baseline. Outcome analyses used mixed models in the intention-to-treat population. Planned mediation indirect linear regression models examined appraisals of poor social support, emotional difficulties, interpersonal problem-solving difficulties, defeat, entrapment, and hopelessness as mediators at 6 months with allocation condition (treatment vs control) as the predictor variable and suicidal ideation severity (ASIQ) at 6 months as the outcome variable, whilst controlling for baseline levels of the mediator and outcome variables. The trial was registered before recruitment at ClinicalTrials.gov (NCT03114917) and ISRCTN (ISRCTN17776666) and is complete.
We recruited participants from four NHS sites from June 21, 2017, to Nov 25, 2020, with the final 12-month assessment completed on Jan 10, 2022. 479 participants were screened for eligibility, and of these 329 (69%) provided consent and were enrolled. After 69 participants were lost to follow-up, 292 participants were randomly allocated to the treatment and control groups (149 [51%] and 143 [49%], respectively). At baseline, 161 (55%) participants were male and 130 (45%) were female; one participant (<1%) in the treatment group was missing gender data. Mean age was 35·1 years (SD 13·2; range 18-69), and 247 (85%) were White or Caucasian. Severity of suicidal ideation was not statistically different between the treatment (n=136) and the control groups (n=116) at 6 months (p=0·07; Cohen's d -0·20 [95% CI -0·42 to 0·02]). A significant indirect mediation effect (-2·85, -7·00 to -0·23) showed that therapy strengthened social support appraisals which, in turn, reduced suicidal ideation severity at 6 months more in the treatment group than in the control group. Suicide attempts were the most frequent severe adverse event (132 attempts in 26 participants in the treatment group vs 91 attempts in 30 participants in the control group). There were four deaths in the CARMS study, none of which were by suicide or considered related to treatment.
CBSPp had no effect on suicidal ideation at 6 months, but it did have a significant indirect effect via improving appraisals of social support. It is important to explore how suicide-focused therapies can be developed and implemented in mental health services so that they maximally enhance appraisals of social support and social connection in ways that endure.
Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership (reference number: 13/161/25).
Gooding P
，Pratt D
，Edwards D
，Awenat Y
，Drake RJ
，Emsley R
，Jones S
，Kapur N
，Lobban F
，Peters S
，Boardman B
，Harris K
，Huggett C
，Haddock G
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How Does Shame Relate to Clinical and Psychosocial Outcomes in Knee Osteoarthritis?
Knee osteoarthritis (OA) is a common and disabling condition that often carries severe psychosocial implications. Chronic illness-related shame has emerged as a substantial psychosocial factor affecting individuals with knee OA, but it is unclear how chronic illness-related shame is associated with the long-term clinical and psychosocial outcomes in individuals with knee OA.
(1) Does a higher level of shame correlate with worse clinical and psychosocial outcomes at baseline among individuals with knee OA? (2) Is a higher level of shame at baseline associated with worse clinical and psychosocial outcomes at 4-month and 12-month follow-up among individuals with knee OA? (3) Are sociodemographic characteristics correlated with levels of shame among individuals with knee OA?
Between June 2021 and February 2022, we screened 977 patients based on the inclusion criteria of (1) age 45 years or older, (2) independent in community mobility with or without walking aids, (3) proficient in English or Chinese language, and (4) met the clinical criteria for OA diagnosis outlined by the National Institute for Health and Care Excellence. Of these patients, 47% (460) were eligible and enrolled. A further 53% (517) were excluded for prespecified reasons. Of the 460 enrolled patients, 7% (30) dropped out before data collection began, and 46% (210) of patients did not complete the psychological questionnaires, leaving 48% (220) of patients for analysis. From this final sample, 25% (56) were lost to follow-up at 4 months, and an additional 7% (16) were lost by the 12-month follow-up, leaving 67% (148) of the original eligible group for analysis. All patients were recruited from the outpatient clinics of the orthopaedic and physiotherapy departments across two Singapore hospitals within the National Healthcare Group. The study population had a mean ± SD age of 64 ± 8 years, with 69% (152 of 220) women, and the mean ± SD duration of knee OA symptoms was 6 ± 6 years. Outcome measures used were the Chronic Illness-Related Shame Scale (CISS), the 12-item Knee Injury and Osteoarthritis Outcome Score (KOOS-12), Patient Health Questionnaire 4 (PHQ-4), the 8-item Arthritis Self-Efficacy Scale (ASES-8), and the Brief Fear of Movement Scale (BFOM). The CISS is a validated tool specifically designed to measure feelings of shame (internal and external shame) in individuals living with chronic illness. The scale has been validated for use among patients with knee OA in Singapore. The functional outcome measure used was the Modified Barthel Index. Data on demographic characteristics were collected. Data were collected at baseline, 4-month follow-up, and 12-month follow-up. Statistical analyses included the Spearman correlation, linear regression, and cluster analysis.
At baseline, there was a weak to moderate negative correlation between CISS scores and KOOS-12 and ASES-8 scores (Spearman correlation coefficients ranged from -0.46 to -0.36; all p values < 0.001), indicating that higher levels of shame were associated with slightly to moderately worse knee function and lower self-efficacy. There was a modest positive correlation between CISS scores and PHQ-4 and BFOM scores (the Spearman correlation coefficients ranged from 0.43 to 0.46; all p values < 0.001), indicating that higher levels of shame were linked to more psychological distress and greater fear of movement. At the 4-month follow-up, a higher CISS score at baseline was associated with a decrease in KOOS-12 (adjusted coefficient -0.86 [95% confidence interval (CI) -1.33 to -0.40]; p < 0.001) and ASES-8 (adjusted coefficient -0.12 [95% CI -0.19 to -0.06]; p < 0.001) scores, indicating worsened knee function and reduced self-efficacy over time. Higher CISS scores at baseline were also associated with an increase in PHQ-4 (adjusted coefficient 0.23 [95% CI 0.14 to 0.31]; p < 0.001) and BFOM (adjusted coefficient 0.22 [95% CI 0.08 to 0.36]; p = 0.002) scores at the 4-month follow-up, reflecting greater psychological distress and greater fear of movement. At the 12-month follow-up, a higher CISS score at baseline was associated with a decrease in KOOS-12 (adjusted coefficient -0.72 [95% CI -1.25 to -0.19]; p = 0.008) and ASES-8 (adjusted coefficient -0.12 [95% CI -0.20 to -0.04]; p = 0.002) scores, indicating that those with higher initial levels of shame continued to experience poorer knee function and lower self-efficacy. Higher CISS scores at baseline were also associated with an increase in PHQ-4 (adjusted coefficient 0.13 [95% CI 0.04 to 0.21]; p = 0.004) as well as BFOM (adjusted coefficient 0.20 [95% CI 0.06 to 0.34]; p = 0.007) scores at the 12-month follow-up, indicating ongoing psychological distress and fear of movement. Cluster analysis found that unemployed older patients with lower CISS scores and BMI, as well as having unilateral arthritis and shorter duration of OA, were observed to have better knee function at 4 months (mean difference 7 [95% CI 1 to 12]; p = 0.02) and 12 months (mean difference 7 [95% CI 1 to 13]; p = 0.02) compared with the opposite. After controlling for age, gender, ethnicity, and employment status, the regression analysis found that higher BMI was related to higher CISS scores (adjusted coefficient 0.21 [95% CI 0.07 to 0.34]; p = 0.003).
Chronic illness-related shame has a small to modest association with clinical and psychosocial outcomes for individuals with knee OA. Healthcare professionals should routinely incorporate psychosocial assessments to identify and manage shame early, potentially improving both clinical and psychosocial outcomes. Recognizing that higher BMI is linked to increased shame can specifically guide targeted emotional and psychosocial support. Additionally, integrating interventions such as acceptance and commitment therapy and peer support with traditional treatments could enhance adherence and overall patient outcomes, making comprehensive care more effective.
Level II, prognostic study.
Yeo JY
，Lim CJ
，Yang SY
，Tan BY
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ResearchGate
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