Plasma Methylmalonic Acid Concentration in Folic Acid-Supplemented Depressed Patients with Low or Marginal Vitamin B-12: A Randomized Trial

BACKGROUND: Individuals with low serum vitamin B-12 and high serum folate have higher plasma concentrations of methylmalonic acid (MMA). Whether folic acid (FA) causes an increase in MMA is not known. OBJECTIVES: We aimed to determine the impact of FA supplementation on plasma MMA concentration in people with low or marginal serum vitamin B-12. METHODS: We conducted a multicenter double-blind placebo-controlled randomized trial of oral FA (5 mg/d for 12 wk) in middle-aged patients treated with antidepressant medication participating in the FoLATED (Folate Augmentation of Treatment—Evaluation for Depression) trial. Participants defined as having “low” serum vitamin B-12 (vitamin B-12 ≥150 and <220 ng/L) or “marginal” serum vitamin B-12 (vitamin B-12 ≥ 220 and <280 ng/L) were included. The primary outcome of this substudy was MMA at week 12. A mixed-effects linear regression was fitted and reported using the adjusted mean difference (aMD). RESULTS: A total of 177 participants were included (85 randomly assigned to placebo and 92 to FA); the mean ± SD age was 46.2 ± 11.8 y, and 112 (63.3%) were female. The MMA analysis included 135 participants and the aMD was −0.01 (95% CI: −0.06, 0.04; P = 0.71). Serum folate was measured on 166 participants and increased in the supplementation group; the aMD was 21.6 μg/L (95% CI: 8.13, 25.02 μg/L; P < 0.001). A total of 117 participants were assessed for RBC folate, which also increased in the supplementation group; the aMD was 461 μg/L (95% CI: 387, 535 μg/L; P < 0.001). CONCLUSIONS: Supplementation of FA leads to an increase of serum and RBC folate, but does not change plasma MMA concentration in individuals with serum vitamin B-12 between 150 and 280 ng/L. We cannot exclude effects in older people or those with serum vitamin B-12 <150 ng/L. Previously reported associations may arise from effects of impaired vitamin B-12 status on folate metabolism. This trial was registered at www.isrctn.com as ISRCTN37558856

The feasibility of delivering the ADVANCE digital intervention to reduce intimate partner abuse by men receiving substance use treatment:protocol for a non-randomised multi-centre feasibility study and embedded process evaluation

BACKGROUND: Compared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery. METHODS/DESIGN: This mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men’s female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention’s acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life. DISCUSSION: Findings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA. TRIAL REGISTRATION: The feasibility study was prospectively registered: ISRCTN66619273

Adapting the ADVANCE group program for digitally-supported delivery to reduce intimate partner violence by men in substance use treatment: a feasibility study

IntroductionCOVID-19 restrictions created barriers to “business as usual” in healthcare but also opened the door to innovation driven by necessity. This manuscript (1) describes how ADVANCE, an in-person group perpetrator program to reduce intimate partner violence (IPV) against female (ex)partners by men in substance use treatment, was adapted for digitally-supported delivery (ADVANCE-D), and (2) explores the feasibility and acceptability of delivering ADVANCE-D to men receiving substance use treatment.MethodsFirstly, the person-based approach and mHealth development framework were used to iteratively adapt ADVANCE for digitally-supported delivery including conceptualization, formative research, and pre-testing. Then, a non-randomized feasibility study was conducted to assess male participants’ eligibility, recruitment, and attendance rates and uptake of support offered to their (ex)partners. Exploratory analyses on reductions in IPV perpetration (assessed using the Abusive Behavior Inventory; ABI) and victimization (using the revised ABI; ABI-R) at the end of the program were performed. Longitudinal qualitative interviews with participants, their (ex)partners, and staff provided an understanding of the program’s implementation, acceptability, and outcomes.ResultsThe adapted ADVANCE-D program includes one goal-setting session, seven online groups, 12 self-directed website sessions, and 12 coaching calls. ADVANCE-D includes enhanced risk management and support for (ex)partners. Forty-five participants who had perpetrated IPV in the past 12 months were recruited, forty of whom were offered ADVANCE-D, attending 11.4 (SD 9.1) sessions on average. Twenty-one (ex)partners were recruited, 13 of whom accepted specialist support. Reductions in some IPV perpetration and victimization outcome measures were reported by the 25 participants and 11 (ex)partners interviewed pre and post-program, respectively. Twenty-two participants, 11 (ex)partners, 12 facilitators, and 7 integrated support service workers were interviewed at least once about their experiences of participation. Overall, the program content was well-received. Some participants and facilitators believed digital sessions offered increased accessibility.ConclusionThe digitally-supported delivery of ADVANCE-D was feasible and acceptable. Remote delivery has applicability post-pandemic, providing greater flexibility and access. Given the small sample size and study design, we do not know if reductions in IPV were due to ADVANCE-D, time, participant factors, or chance. More research is needed before conclusions can be made about the efficacy of ADVANCE-D

Feasibility Randomised Trial Comparing Two Forms of Mental Health Supported Accommodation (Supported Housing and Floating Outreach); a Component of the QuEST (Quality and Effectiveness of Supported Tenancies) Study

Background: Mental health supported accommodation services are implemented across England, usually organised into a ‘step-down’ care pathway that requires the individual to repeatedly move as they gain skills and confidence for more independent living. There have been no trials comparing the effectiveness of different types of supported accommodation, but two widely used models (supported housing and floating outreach) have been found to provide similar support. We aimed to assess the feasibility of conducting a large-scale trial comparing these two models. Methods: Individually randomised, parallel group feasibility trial in three regions of England (North London, East London, and Cheltenham and Gloucestershire). We aimed to recruit 60 participants in 15 months, referred to supported accommodation, randomly allocated on an equal basis to receive either a local supported housing or floating outreach service. We assessed referrals to the trial, participants recruited, attrition, time from recruitment to moving into either type of supported accommodation, and feasibility of masking. We conducted a process evaluation to examine our results further. Results: We screened 1,432 potential participants, of whom 17 consented to participate, with 8 agreeing to randomisation (of whom 1 was lost to attrition) and 9 participating in naturalistic follow-up. Our process evaluation indicated that the main obstacle to recruitment was staff and service user preferences for certain types of supported accommodation or for specific services. Staff also felt that randomisation compromised their professional judgement. Conclusions: Our results do not support investment in a large-scale trial in England at this time

The feasibility of delivering the ADVANCE digital intervention to reduce intimate partner abuse by men receiving substance use treatment : protocol for a non-randomised multi-centre feasibility study and embedded process evaluation

BACKGROUND: Compared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery.METHODS/DESIGN: This mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention's acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life.DISCUSSION: Findings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA.TRIAL REGISTRATION: The feasibility study was prospectively registered: ISRCTN66619273 .</p