Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND): a multicentre, parallel, randomised controlled trial in the UK.

BACKGROUND: Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Acceptance and Commitment Therapy (ACT) is a psychological therapy incorporating acceptance, mindfulness, and behaviour change techniques. We aimed to evaluate the effectiveness of ACT plus usual care, compared with usual care alone, for improving quality of life in people with motor neuron disease. METHODS: We conducted a parallel, multicentre, two-arm randomised controlled trial in 16 UK motor neuron disease care centres or clinics. Eligible participants were aged 18 years or older with a diagnosis of definite or laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis; progressive muscular atrophy; or primary lateral sclerosis; which met the World Federation of Neurology's El Escorial diagnostic criteria. Participants were randomly assigned (1:1) to receive up to eight sessions of ACT adapted for people with motor neuron disease plus usual care or usual care alone by a web-based system, stratified by site. Participants were followed up at 6 months and 9 months post-randomisation. Outcome assessors and trial statisticians were masked to treatment allocation. The primary outcome was quality of life using the McGill Quality of Life Questionnaire-Revised (MQOL-R) at 6 months post-randomisation. Primary analyses were multi-level modelling and modified intention to treat among participants with available data. This trial was pre-registered with the ISRCTN Registry (ISRCTN12655391). FINDINGS: Between Sept 18, 2019, and Aug 31, 2022, 435 people with motor neuron disease were approached for the study, of whom 206 (47%) were assessed for eligibility, and 191 were recruited. 97 (51%) participants were randomly assigned to ACT plus usual care and 94 (49%) were assigned to usual care alone. 80 (42%) of 191 participants were female and 111 (58%) were male, and the mean age was 63·1 years (SD 11·0). 155 (81%) participants had primary outcome data at 6 months post-randomisation. After controlling for baseline scores, age, sex, and therapist clustering, ACT plus usual care was superior to usual care alone for quality of life at 6 months (adjusted mean difference on the MQOL-R of 0·66 [95% CI 0·22-1·10]; d=0·46 [0·16-0·77]; p=0·0031). Moderate effect sizes were clinically meaningful. 75 adverse events were reported, 38 of which were serious, but no adverse events were deemed to be associated with the intervention. INTERPRETATION: ACT plus usual care is clinically effective for maintaining or improving quality of life in people with motor neuron disease. As further evidence emerges confirming these findings, health-care providers should consider how access to ACT, adapted for the specific needs of people with motor neuron disease, could be provided within motor neuron disease clinical services. FUNDING: National Institute for Health and Care Research Health Technology Assessment and Motor Neurone Disease Association.

Cost-effectiveness of acceptance and commitment therapy for people living with motor neuron disease, and their health-related quality of life.

BACKGROUND: Given the degenerative nature of the condition, people living with motor neuron disease (MND) experience high levels of psychological distress. The purpose of this research was to investigate the cost-effectiveness of acceptance and commitment therapy (ACT), adapted for the specific needs of this population, for improving quality of life. METHODS: A trial-based cost-utility analysis over a 9-month period was conducted comparing ACT plus usual care (n = 97) versus usual care alone (n = 94) from the perspective of the National Health Service. In the primary analysis, quality-adjusted life years (QALYs) were computed using health utilities generated from the EQ-5D-5L questionnaire. Sensitivity analyses and subgroup analyses were also carried out. RESULTS: Difference in costs was statistically significant between the two arms, driven mainly by the intervention costs. Effects measured by EQ-5D-5L were not statistically significantly different between the two arms. The incremental cost-effectiveness was above the £20,000 to £30,000 per QALY gained threshold used in the UK. However, the difference in effects was statistically significant when measured by the McGill Quality of Life-Revised (MQOL-R) questionnaire. The intervention was cost-effective in a subgroup experiencing medium deterioration in motor neuron symptoms. CONCLUSIONS: Despite the intervention being cost-ineffective in the primary analysis, the significant difference in the effects measured by MQOL-R, the low costs of the intervention, the results in the subgroup analysis, and the fact that ACT was shown to improve the quality of life for people living with MND, suggest that ACT could be incorporated into MND clinical services.

Antidepressants for pain management in adults with chronic pain: a network meta-analysis.

BACKGROUND: Chronic pain is common in adults, and often has a detrimental impact upon physical ability, well-being, and quality of life. Previous reviews have shown that certain antidepressants may be effective in reducing pain with some benefit in improving patients' global impression of change for certain chronic pain conditions. However, there has not been a network meta-analysis (NMA) examining all antidepressants across all chronic pain conditions. OBJECTIVES: To assess the comparative efficacy and safety of antidepressants for adults with chronic pain (except headache). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, AMED and PsycINFO databases, and clinical trials registries, for randomised controlled trials (RCTs) of antidepressants for chronic pain conditions in January 2022. SELECTION CRITERIA: We included RCTs that examined antidepressants for chronic pain against any comparator. If the comparator was placebo, another medication, another antidepressant, or the same antidepressant at different doses, then we required the study to be double-blind. We included RCTs with active comparators that were unable to be double-blinded (e.g. psychotherapy) but rated them as high risk of bias. We excluded RCTs where the follow-up was less than two weeks and those with fewer than 10 participants in each arm.  DATA COLLECTION AND ANALYSIS: Two review authors separately screened, data extracted, and judged risk of bias. We synthesised the data using Bayesian NMA and pairwise meta-analyses for each outcome and ranked the antidepressants in terms of their effectiveness using the surface under the cumulative ranking curve (SUCRA). We primarily used Confidence in Meta-Analysis (CINeMA) and Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) to assess the certainty of the evidence. Where it was not possible to use CINeMA and ROB-MEN due to the complexity of the networks, we used GRADE to assess the certainty of the evidence. Our primary outcomes were substantial (50%) pain relief, pain intensity, mood, and adverse events. Our secondary outcomes were moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change (PGIC), serious adverse events, and withdrawal. MAIN RESULTS: This review and NMA included 176 studies with a total of 28,664 participants. The majority of studies were placebo-controlled (83), and parallel-armed (141). The most common pain conditions examined were fibromyalgia (59 studies); neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of RCTs was 10 weeks. Seven studies provided no useable data and were omitted from the NMA. The majority of studies measured short-term outcomes only and excluded people with low mood and other mental health conditions. Across efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. In duloxetine studies, standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that of duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.  Primary efficacy outcomes Duloxetine standard dose (60 mg) showed a small to moderate effect for substantial pain relief (odds ratio (OR) 1.91, 95% confidence interval (CI) 1.69 to 2.17; 16 studies, 4490 participants; moderate-certainty evidence) and continuous pain intensity (standardised mean difference (SMD) -0.31, 95% CI -0.39 to -0.24; 18 studies, 4959 participants; moderate-certainty evidence). For pain intensity, milnacipran standard dose (100 mg) also showed a small effect (SMD -0.22, 95% CI -0.39 to 0.06; 4 studies, 1866 participants; moderate-certainty evidence). Mirtazapine (30 mg) had a moderate effect on mood (SMD -0.5, 95% CI -0.78 to -0.22; 1 study, 406 participants; low-certainty evidence), while duloxetine showed a small effect (SMD -0.16, 95% CI -0.22 to -0.1; 26 studies, 7952 participants; moderate-certainty evidence); however it is important to note that most studies excluded participants with mental health conditions, and so average anxiety and depression scores tended to be in the 'normal' or 'subclinical' ranges at baseline already. Secondary efficacy outcomes Across all secondary efficacy outcomes (moderate pain relief, physical function, sleep, quality of life, and PGIC), duloxetine and milnacipran were the highest-ranked antidepressants with moderate-certainty evidence, although effects were small. For both duloxetine and milnacipran, standard doses were as efficacious as high doses. Safety There was very low-certainty evidence for all safety outcomes (adverse events, serious adverse events, and withdrawal) across all antidepressants. We cannot draw any reliable conclusions from the NMAs for these outcomes. AUTHORS' CONCLUSIONS: Our review and NMAs show that despite studies investigating 25 different antidepressants, the only antidepressant we are certain about for the treatment of chronic pain is duloxetine. Duloxetine was moderately efficacious across all outcomes at standard dose. There is also promising evidence for milnacipran, although further high-quality research is needed to be confident in these conclusions. Evidence for all other antidepressants was low certainty. As RCTs excluded people with low mood, we were unable to establish the effects of antidepressants for people with chronic pain and depression. There is currently no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point.

Experiential Avoidance in Advanced Cancer: a Mixed-Methods Systematic Review.

BACKGROUND: People with advanced cancer experience psychological distress due to physical symptoms, functional decline, and a limited prognosis. Difficult thoughts, feelings, and emotions may exacerbate distress and lead to avoidance of these experiences which is sometimes referred to as experiential avoidance (EA). Advanced cancer patients may be more likely to engage in EA especially when no obvious solutions to their problems exist. This study aims to examine the terms used to describe EA, the processes that might indicate EA, associations between EA and psychological distress, and to understand why individuals might engage in EA. METHODS: A mixed-methods review. Literature search of Medline, Embase, Psych INFO, and CINAHL 1980-October 2019. INCLUSION: adults ≥ 18 years; advanced cancer not amenable to cure. EXCLUSION: no measures of EA or psychological distress. Risk of bias and study quality assessed. Evidence of statistical techniques collected. Themes coded, grouped, and developed based on meaning. RESULTS: Nineteen studies identified, 13 quantitative studies and 6 qualitative. The quantitative of which 6 compared early-stage cancers with advanced cancers and examined subscales of EA alongside mood, quality of life, and psychological distress. EA covers a range or terms of which 'avoidant coping' is the commonest. EA is manifest as cognitive, behavioural, and emotional avoidance. A thematic synthesis suggests the function of EA is to protect people from distress, and from confronting or expressing difficult emotions by avoiding communication about cancer, controlling negative information, and maintaining normality and hope and optimism. CONCLUSIONS: EA may be beneficial in the short term to alleviate distress, but in the longer term, it can impair function and limit engagement in life. Greater clinical awareness of the complexity of EA behaviours is needed. Clinicians and researchers should define EA precisely and be aware of the function it may serve in the short and longer term. Future research studies may consider using specific measures of EA as a primary outcome, to assess the impact of psychological interventions such as ACT.

A randomised controlled trial of acceptance and commitment therapy plus usual care compared to usual care alone for improving psychological health in people with motor neuron disease (COMMEND): study protocol.

BACKGROUND: Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predominantly affects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weakening of bulbar, limb, abdominal and thoracic muscles. Prognosis is poor and median survival is 2-3 years following symptom onset. Psychological distress is relatively common in people living with MND. However, formal psychotherapy is not routinely part of standard care within MND Care Centres/clinics in the UK, and clear evidence-based guidance on improving the psychological health of people living with MND is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT) may be particularly suitable for people living with MND and may help improve their psychological health. AIMS: To assess the clinical and cost-effectiveness of ACT modified for MND plus usual multidisciplinary care (UC) in comparison to UC alone for improving psychological health in people living with MND. METHODS: The COMMEND trial is a multi-centre, assessor-blind, parallel, two-arm RCT with a 10-month internal pilot phase. 188 individuals aged ≥ 18 years with a diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis, and additionally the progressive muscular atrophy and primary lateral sclerosis variants, will be recruited from approximately 14 UK-based MND Care Centres/clinics and via self-referral. Participants will be randomly allocated to receive up to eight 1:1 sessions of ACT plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and at 6- and 9-months post-randomisation. The primary outcome will be quality of life at six months. Secondary outcomes will include depression, anxiety, psychological flexibility, health-related quality of life, adverse events, ALS functioning, survival at nine months, satisfaction with therapy, resource use and quality-adjusted life years. Primary analyses will be by intention to treat and data will be analysed using multi-level modelling. DISCUSSION: This trial will provide definitive evidence on the clinical and cost-effectiveness of ACT plus UC in comparison to UC alone for improving psychological health in people living with MND. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12655391. Registered 17 July 2017, https://www.isrctn.com/ISRCTN12655391 . PROTOCOL VERSION: 3.1 (10/06/2020).

Acceptance and commitment therapy for late-life treatment-resistant generalised anxiety disorder: a feasibility study.

BACKGROUND: Generalised anxiety disorder (GAD) is the most common anxiety disorder in older people. First-line management includes pharmacological and psychological therapies, but many do not find these effective or acceptable. Little is known about how to manage treatment-resistant generalised anxiety disorder (TR-GAD) in older people. OBJECTIVES: To examine the acceptability, feasibility and preliminary estimates of the effectiveness of acceptance and commitment therapy (ACT) for older people with TR-GAD. PARTICIPANTS: People aged ≥65 years with TR-GAD (defined as not responding to GAD treatment, tolerate it or refused treatment) recruited from primary and secondary care services and the community. INTERVENTION: Participants received up to 16 one-to-one sessions of ACT, developed specifically for older people with TR-GAD, in addition to usual care. MEASUREMENTS: Co-primary outcomes were feasibility (defined as recruitment of ≥32 participants and retention of ≥60% at follow-up) and acceptability (defined as participants attending ≥10 sessions and scoring ≥21/30 on the satisfaction with therapy subscale). Secondary outcomes included measures of anxiety, worry, depression and psychological flexibility (assessed at 0 and 20 weeks). RESULTS: Thirty-seven participants were recruited, 30 (81%) were retained and 26 (70%) attended ≥10 sessions. A total of 18/30 (60%) participants scored ≥21/30 on the satisfaction with therapy subscale. There was preliminary evidence suggesting that ACT may improve anxiety, depression and psychological flexibility. CONCLUSIONS: There was evidence of good feasibility and acceptability, although satisfaction with therapy scores suggested that further refinement of the intervention may be necessary. Results indicate that a larger-scale randomised controlled trial of ACT for TR-GAD is feasible and warranted.

Views of healthcare professionals on recruiting to a psychosocial randomised controlled trial: a qualitative study.

BACKGROUND: Randomised controlled trials, and in particular those of psychosocial interventions, often fail to recruit to target, resulting in underpowered trials with poor generalisability of findings. The objectives of this study were to explore the views of healthcare professionals on recruiting to psychosocial research studies, and to explore their views on factors that may hinder or facilitate recruitment. METHODS: We conducted 14 semi-structured interviews, with healthcare professionals who had been involved in recruitment into a randomised controlled trial of a talking therapy for depression in patients with advanced cancer. Interviews were transcribed and analysed using thematic analysis. RESULTS: Five primary themes were identified, comprised of 11 subthemes. Attitudes towards research were largely positive. Health care professionals identified lack of time and narrow screening criteria as barriers to recruitment, and also noted the tendency to withhold participants from research for reasons other than eligibility (e.g., gatekeeping). The engagement of the study team with the clinical recruitment site, and the frequent presence of a researcher in clinics, were noted as facilitating recruitment. CONCLUSIONS: Healthcare professionals involved in recruiting to trials of psychosocial interventions hold generally positive views of psychosocial research. However, they report that constraints including space and time limit their ability to recruit, and express anxieties about approaching patients for trial recruitment in the palliative phase of their illness. The findings from this study can inform how best to design trials, and in particular trials of psychosocial interventions, and train health care professionals for the study, to maximise recruitment.

Effectiveness of cognitive-behavioural therapy for depression in advanced cancer: CanTalk randomised controlled trial.

BACKGROUND: Depression is one of the most common mental disorders in people with advanced cancer. Although cognitive-behavioural therapy (CBT) has been shown to be effective for depression in people with cancer, it is unclear whether this is the case for people with advanced cancer and depression. AIMS: We sought to determine whether CBT is more clinically effective than treatment as usual (TAU) for treating depression in people with advanced cancer (trial registration number ISRCTN07622709). METHOD: A multi-centre, parallel-group single-blind randomised controlled trial comparing TAU with CBT (plus TAU). Participants (n = 230) with advanced cancer and depression were randomly allocated to (a) up to 12 sessions of individual CBT or (b) TAU. The primary outcome measure was the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, and Satisfaction with Care. RESULTS: Multilevel modelling, including complier-average intention-to-treat analysis, found no benefit of CBT. CBT delivery was proficient, but there was no treatment effect (-0.84, 95% CI -2.76 to 1.08) or effects for secondary measures. Exploratory subgroup analysis suggested an effect of CBT on the BDI-II in those widowed, divorced or separated (-7.21, 95% CI -11.15 to -3.28). CONCLUSIONS: UK National Institute for Health and Care Excellence (NICE) guidelines recommend CBT for treating depression. Delivery of CBT through the Improving Access to Psychological Therapies (IAPT) programme has been advocated for long-term conditions such as cancer. Although it is feasible to deliver CBT through IAPT proficiently to people with advanced cancer, this is not clinically effective. CBT for people widowed, divorced or separated needs further exploration. Alternate models of CBT delivery may yield different results.

A pragmatic approach to measuring adherence in treatment delivery in psychotherapy.

Measuring therapists' adherence to treatment manuals is recommended for evaluating treatment integrity, yet ways to do this are poorly defined, time consuming, and costly. The aims of the study were to develop a Therapy Component Checklist (TCC) to measure adherence to manualised CBT; to test its application in research and clinical practice; to determine its validity; and consider its cost benefits. We conducted a randomised trial in 230 people with cancer evaluating effectiveness of CBT for depression. In this, therapists delivered manualised treatment.  Experts agreed on key components of therapy and therapists were asked to record these after therapy sessions by ticking a TCC. Inter-rater reliability was tested using an independent rater.  Therapists delivered 543 CBT sessions. TCCs were completed in 293, of which 39 were assessed by the independent rater. Self-reported TCC data suggested close adherence to the manual. Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  Self-rating of adherence saved around £96 per rating. In conclusion the TCC provides a quick and cost effective way of evaluating the components of therapy delivered. This approach could be applied to other psychological treatments and may help with linking therapeutic interventions with outcome.

Acceptance and commitment therapy for adults with advanced cancer (CanACT): A feasibility randomised controlled trial.

OBJECTIVE: To understand the feasibility of recruiting people with advanced cancer into a randomised controlled trial of acceptance and commitment therapy (ACT) vs a standardised talking control (TC) and delivering ACT to this population; to explore the acceptability of outcome measures and generate normative data. METHODS: This was a feasibility two-arm randomised controlled trial. Participants were attendees with advanced cancer at one of three hospice-based day-therapy units in London, United Kingdom, who demonstrated low scores on the Functional Assessment of Cancer Therapies-General (FACT-G). The primary end point was 3 months. RESULTS: The recruitment target was 54 participants; 42 people were recruited and randomised to up to eight individual sessions of ACT (n = 20) or TC (n = 22). Eighteen out of 42 (43%) of participants completed the primary outcome at 3 months, and at least one follow-up was available in 30/42 (71%) participants. An exploratory analysis revealed a non-significant adjusted mean difference after 3 months in the main outcome FACT-G of -3.41 (CI = -18.61-11.79) with TC having better functioning. Over 6 months, the adjusted mean difference between trial arms was 2.25 (CI = -6.03-10.52) in favour of ACT. CONCLUSIONS: It is feasible to recruit people with advanced cancer in a trial of ACT versus TC. Future research should test the effectiveness of ACT in a fully powered trial.

Optimising the acceptability and feasibility of acceptance and commitment therapy for treatment-resistant generalised anxiety disorder in older adults.

BACKGROUND: generalised anxiety disorder (GAD) is common in later life with a prevalence of 3-12%. Many only partially respond to cognitive behavioural therapy or pharmacotherapy and can be classified as treatment resistant. These patients experience poor quality of life, and are at increased risk of comorbid depression, falls and loneliness. Acceptance and commitment therapy (ACT) is an emerging therapy, which may be particularly suited to this population, but has not been tailored to their needs. OBJECTIVES: to optimise the acceptability and feasibility of ACT for older adults with treatment-resistant GAD. DESIGN: a person-based approach to ground the adapted ACT intervention in the perspectives and lives of those who will use it. METHODS: first, we conducted qualitative interviews with 15 older adults with GAD and 36 healthcare professionals to develop guiding principles to inform the intervention. Second, we consulted service users and clinical experts and interviewed the same 15 older adults using 'think aloud' techniques to enhance its acceptability and feasibility. RESULTS: in Stage 1, older adults' concerns and needs were categorised in four themes: 'Expert in one's own condition', 'Deep seated coping strategies', 'Expert in therapy' and 'Support with implementation'. In Stage 2, implications for therapy were identified that included an early focus on values and ACT as a collaborative partnership, examining beliefs around 'self as worrier' and the role of avoidance, validating and accommodating individuals' knowledge and experience and compensating for age-related cognitive changes. DISCUSSION: Our systematic approach combined rigour and transparency to develop a therapeutic intervention tailored to the specific needs of older adults with treatment-resistant GAD.

Delivering cognitive behavioural therapy to advanced cancer patients: A qualitative exploration into therapists' experiences within a UK psychological service.

BACKGROUND: Cognitive behavioural therapy (CBT) is commonly used to treat cancer patients with psychological disorders such as depression. There has been little qualitative research exploring the experience of therapists delivering CBT to patients with advanced cancer and long-term health conditions generally. Therapists' views may help identify difficulties in delivering therapy and how these may be overcome. The aim of this study was to inform practice by qualitatively exploring the experiences of therapists delivering CBT to patients with advanced cancer. DESIGN: Sixteen semi-structured interviews were conducted with therapists from Increasing Access to Psychological Therapy (IAPT) services in London, UK, who had delivered CBT to patients enrolled on the CanTalk trial. Interviews were recorded, transcribed, and analysed using framework analysis. RESULTS: Therapists reported positive experiences when working with the target population. Flexibility, adaptability, and a consideration of individual needs were identified as important when delivering CBT, but the rigidity of IAPT policies and demand for services were perceived as problematic. Although therapists reported adequate training, specialist supervision was desired when delivering therapy to this complex population. CONCLUSION: IAPT therapists can deliver CBT to advanced cancer patients, given therapists positive experiences evident in the present study. However, it was concluded that additional service and modifications of therapy may be needed before positive outcomes for both therapists and patients can be achieved.

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness--ERRATUM.

The author list previously published for this article was incomplete when received by the journal. It should also have included Gerard Leavey, University College London, UK, as an author, as follows: Marc Serfaty, Anna Ridgewell, Vari Drennan, Chris R. Brewin, Gerard Leavey, Anwen Wright, Gloria Laycock, Martin Blanchard.

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness.

BACKGOUND: Limited data suggest that crime may have a devastating impact on older people. Although identification and treatment may be beneficial, no well-designed studies have investigated the prevalence of mental disorder and the potential benefits of individual manualized CBT in older victims of crime. AIMS: To identify mental health problems in older victims of common crime, provide preliminary data on its prevalence, and conduct a feasibility randomized controlled trial (RCT) using mixed methods. METHOD: Older victims, identified through police teams, were screened for symptoms of anxiety, depression or post-traumatic stress disorder (PTSD) one (n = 581) and 3 months (n = 486) after experiencing a crime. Screen positive participants were offered diagnostic interviews. Of these, 26 participants with DSM-IV diagnoses agreed to be randomized to Treatment As Usual (TAU) or TAU plus our manualized CBT informed Victim Improvement Package (VIP). The latter provided feedback on the VIP. RESULTS: Recruitment, assessment and intervention are feasible and acceptable. At 3 months 120/486 screened as cases, 33 had DSM-IV criteria for a psychiatric disorder; 26 agreed to be randomized to a pilot trial. There were trends in favour of the VIP in all measures except PTSD at 6 months post crime. CONCLUSIONS: This feasibility RCT is the first step towards improving the lives of older victims of common crime. Without intervention, distress at 3 and 6 months after a crime remains high. However, the well-received VIP appeared promising for depressive and anxiety symptoms, but possibly not posttraumatic stress disorder.

"If we don't forgive, it's like holding on to them": A qualitative study of religious and spiritual coping on psychological recovery in older crime victims.

OBJECTIVE: There is growing need to strengthen support for older crime victims. We aimed to explore spiritual and/or religious (S/R) beliefs in a sample of older victims and understand how this shapes psychological responding and coping with crime. METHOD: Qualitative study with supplementary descriptive statistics nested within a clinical trial. We explored psychological responding and coping in-depth through semistructured interviews with 27 older victims of police-reported crime, purposefully sampled to achieve maximum variation. We inductively analyzed data using a reflexive thematic analysis. We assessed the breadth of S/R beliefs in a large sample (N = 402) of initially distressed older victims using an abbreviated version of The Royal Free Interview for Spiritual Beliefs. We assessed continued psychological distress using the two-item Generalised Anxiety Disorder and Patient Health Questionnaire 3 months postcrime. RESULTS: Over two-thirds (67%) identified as S/R, but psychological distress scores were similar, irrespective of religiosity. Our qualitative analysis suggests that crime may impact religious identity or practice in some older victims (hate crime) but influences attitudes or coping in others. Positive coping included acceptance, forgiveness, and/or turning to prayer or faith communities. Negative coping included fixation on retribution, superstition, perceived abandonment by God, or an inability to accommodate the crime within their beliefs, amplifying psychological distress. CONCLUSIONS: Understanding the psychological impact on older crime victims is enhanced by clarifying the role of S/R. Further research, especially on non-Christian religious victims, is needed. Cultural awareness training for trauma counselors and trauma awareness training for faith leaders is recommended. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Psychological Distress and Interventions for Older Victims of Crime: A Systematic Review.

We aimed to conduct the first systematic narrative review and quality appraisal of existing evidence on the psychological consequences of crime in older victims in the community and psychological interventions. We searched five databases to identify all peer-reviewed literature published in English on psychological impact and/or interventions for older crime victims and quality appraised these using the Mixed-Methods Appraisal Tool, following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines (Prospero: CRD42019140137). Evidence from included studies were narratively synthesized, along with their strengths and limitations. We found 20 studies on psychological distress in older victims, four of which included interventions. From these, we identified 30 different impacts including symptoms of anxiety, depression, post-traumatic stress disorder, emotions including humiliation and self-blame, and behavioral changes. Only feasibility interventions have been published, although promising results were reported for cognitive-behavioral informed treatments for depression and anxiety. Studies were wide-ranging in aims, crimes included, and outcomes used. Recommendations for improving the evidence-base and to raise the profile of this neglected population have been provided.

Acceptance and Commitment Therapy for people living with motor neuron disease: an uncontrolled feasibility study.

BACKGROUND: Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND. METHODS: PlwMND aged ≥ 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (≥ 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (≥ 70% completing ≥ 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months. RESULTS: Both a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended ≥ 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status. CONCLUSIONS: There was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway. TRIAL REGISTRATION: The study was pre-registered with the ISRCTN Registry (ISRCTN12655391).

Talking control sessions in people with advanced cancer: a qualitative analysis of sessions.

BACKGROUND: Talking control (TC) was developed to control for the common factors in therapy so that the specific effects of therapy can be tested. A TC was recently used in a pilot study of Acceptance and Commitment therapy for dysfunction in people with advanced cancer. This work explores the audio recording of the sessions in a TC to explore how they were utilised by people with advanced cancer. METHODS: This is a qualitative study nested in larger feasibility randomised control trial. The trial participants were recruited from three London hospices. The study examined data for 5 participants who received weekly sessions of a TC. Fifteen sessions, three per participant, were transcribed and analysed using a thematic approach. RESULTS: Individuals with advanced cancer used TC sessions as a safe place in which they could express their feelings-from smaller daily concerns to deeper-rooted difficulties. Many participants also engaged in emotional and cognitive avoidance regarding some topics, particularly those pertaining to their cancer. The TC sessions were also used as an opportunity to focus on the more positive aspects of their lives. Lastly, they served to reflect on ways to overcome difficulties. CONCLUSIONS: This study suggests the TC can have beneficial, albeit varying uses for people with advanced cancer, that may even be considered therapeutic.

Cost-effectiveness of cognitive behaviour therapy versus talking and usual care for depressed older people in primary care.

BACKGROUND: Whilst evidence suggests cognitive behaviour therapy (CBT) may be effective for depressed older people in a primary care setting, few studies have examined its cost-effectiveness. The aim of this study was to compare the cost-effectiveness of cognitive behaviour therapy (CBT), a talking control (TC) and treatment as usual (TAU), delivered in a primary care setting, for older people with depression. METHODS: Cost data generated from a single blind randomised controlled trial of 204 people aged 65 years or more were offered only Treatment as Usual, or TAU plus up to twelve sessions of CBT or a talking control is presented. The Beck Depression Inventory II (BDI-II) was the main outcome measure for depression. Direct treatment costs were compared with reductions in depression scores. Cost-effectiveness analysis was conducted using non-parametric bootstrapping. The primary analysis focussed on the cost-effectiveness of CBT compared with TAU at 10 months follow up. RESULTS: Complete cost data were available for 198 patients at 4 and 10 month follow up. There were no significant differences between groups in baseline costs. The majority of health service contacts at follow up were made with general practitioners. Fewer contacts with mental health services were recorded in patients allocated to CBT, though these differences were not significant. Overall total per patient costs (including intervention costs) were significantly higher in the CBT group compared with the TAU group at 10 month follow up (difference £427, 95% CI: £56 - £787, p < 0.001). Reductions in BDI-II scores were significantly greater in the CBT group (difference 3.6 points, 95% CI: 0.7-6.5 points, p = 0.018). CBT is associated with an incremental cost of £120 per additional point reduction in BDI score and a 90% probability of being considered cost-effective if purchasers are willing to pay up to £270 per point reduction in the BDI-II score. CONCLUSIONS: CBT is significantly more costly than TAU alone or TAU plus TC, but more clinically effective. Based on current estimates, CBT is likely to be recommended as a cost-effective treatment option for this patient group if the value placed on a unit reduction in BDI-II is greater than £115. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18271323.

Acceptance and commitment therapy for older people with treatment-resistant generalised anxiety disorder: the FACTOID feasibility study.

BACKGROUND: Generalised anxiety disorder, characterised by excessive anxiety and worry, is the most common anxiety disorder among older people. It is a condition that may persist for decades and is associated with numerous negative outcomes. Front-line treatments include pharmacological and psychological therapy, but many older people do not find these treatments effective. Guidance on managing treatment-resistant generalised anxiety disorder in older people is lacking. OBJECTIVES: To assess whether or not a study to examine the clinical effectiveness and cost-effectiveness of acceptance and commitment therapy for older people with treatment-resistant generalised anxiety disorder is feasible, we developed an intervention based on acceptance and commitment therapy for this population, assessed its acceptability and feasibility in an uncontrolled feasibility study and clarified key study design parameters. DESIGN: Phase 1 involved qualitative interviews to develop and optimise an intervention as well as a survey of service users and clinicians to clarify usual care. Phase 2 involved an uncontrolled feasibility study and qualitative interviews to refine the intervention. SETTING: Participants were recruited from general practices, Improving Access to Psychological Therapies services, Community Mental Health Teams and the community. PARTICIPANTS: Participants were people aged ≥ 65 years with treatment-resistant generalised anxiety disorder. INTERVENTION: Participants received up to 16 one-to-one sessions of acceptance and commitment therapy, adapted for older people with treatment-resistant generalised anxiety disorder, in addition to usual care. Sessions were delivered by therapists based in primary and secondary care services, either in the clinic or at participants' homes. Sessions were weekly for the first 14 sessions and fortnightly thereafter. MAIN OUTCOME MEASURES: The co-primary outcome measures for phase 2 were acceptability (session attendance and satisfaction with therapy) and feasibility (recruitment and retention). Secondary outcome measures included additional measures of acceptability and feasibility and self-reported measures of anxiety, worry, depression and psychological flexibility. Self-reported outcomes were assessed at 0 weeks (baseline) and 20 weeks (follow-up). Health economic outcomes included intervention and resource use costs and health-related quality of life. RESULTS: Fifteen older people with treatment-resistant generalised anxiety disorder participated in phase 1 and 37 participated in phase 2. A high level of feasibility was demonstrated by a recruitment rate of 93% and a retention rate of 81%. A high level of acceptability was found with respect to session attendance (70% of participants attended ≥ 10 sessions) and satisfaction with therapy was adequate (60% of participants scored ≥ 21 out of 30 points on the Satisfaction with Therapy subscale of the Satisfaction with Therapy and Therapist Scale-Revised, although 80% of participants had not finished receiving therapy at the time of rating). Secondary outcome measures and qualitative data further supported the feasibility and acceptability of the intervention. Health economic data supported the feasibility of examining cost-effectiveness in a future randomised controlled trial. Although the study was not powered to examine clinical effectiveness, there was indicative evidence of improvements in scores for anxiety, depression and psychological flexibility. LIMITATIONS: Non-specific therapeutic factors were not controlled for, and recruitment in phase 2 was limited to London. CONCLUSIONS: There was evidence of high levels of feasibility and acceptability and indicative evidence of improvements in symptoms of anxiety, depression and psychological flexibility. The results of this study suggest that a larger-scale randomised controlled trial would be feasible to conduct and is warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12268776. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 54. See the NIHR Journals Library website for further project information.

Generalised anxiety disorder, characterised by a tendency to worry, is the most common anxiety disorder among older people. Those with this condition may experience other difficulties, including increased distress and disability, poorer coping and reduced quality of life. Medication and talking therapy are usually offered as forms of treatment, but many do not find them helpful. Guidance is lacking on how to help older people manage generalised anxiety disorder when it does not respond to such treatments. We developed a 16-session intervention specifically for older people with treatment-resistant generalised anxiety disorder. This was based on acceptance and commitment therapy: a form of talking therapy that helps people to learn how to best live with distressing experiences while still doing things that really matter to them. It may be particularly suited to older people because many older people experience difficulties with chronic ill health and other problems that cannot be easily improved with conventional talking therapies. We developed our intervention by asking 15 older people about their experiences of treatment-resistant generalised anxiety disorder and treatments they have received for it, as well as what might help or hinder their engagement with talking therapy. We combined their guidance with advice from 36 clinicians to ensure that our intervention was tailored to the needs of this population. We then asked the same 15 older people, our Service User Advisory Group and academic clinicians about how we could optimise our intervention. We also conducted an online survey of service users and clinicians to clarify what care older people with generalised anxiety disorder are typically offered and receive. We tested how acceptable our intervention was to 37 older people with treatment-resistant generalised anxiety disorder, and how feasible it was to deliver within the NHS. We found evidence that it was acceptable to participants, that it could be delivered within the NHS and that its value for money could be tested in a larger study. We also found evidence suggestive of improvements in anxiety, depression and coping. There were some limitations of our study. However, overall, our results suggest that we should conduct a larger study to find out whether or not our intervention is helpful for older people with treatment-resistant generalised anxiety disorder.