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Preliminary Support for a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study.

ABSTRACT: Background: Menopause is associated with physical and emotional symptoms, and subjective cognitive concerns that are generally not borne out on objective cognitive measures. This discrepancy suggests that a psychological rather than biological mechanism likely mediates the cognitive concerns of women in menopause. The current study assessed the feasibility and effectiveness of a cognitive remediation intervention with the goal of reducing subjective perceptions of cognitive difficulty during the menopause. Methods: Twenty-seven menopausal women (M age = 53.74, SD = 4.14) completed a 5-week group-based intervention (with a post-group booster) consisting of 2-h weekly sessions. Participants completed pre- and post-intervention measures capturing subjective cognitive ability, mood, anxiety, stress, personality, and objective cognitive tests. The primary variable of interest was self-reported cognitive confidence measured by the Memory and Cognitive Confidence Scale (MACCS). Results: All but one MACCS subscale significantly decreased over the course of treatment (with lower scores associated with higher confidence) and effect sizes ranged from small to large (d = -0.39 to -0.91) with gains maintained at 1-month follow-up. Interestingly, no change in objective cognitive test performance was observed, indicating increases in subjective cognitive confidence in the absence of objective cognitive improvement. There was no change in mood, anxiety, or stress scores. Two-level HLM analyses revealed that those with higher baseline neuroticism, as measured by the NEO Personality Inventory, had smaller decreases in post-group MACCS High Standards subscale relative to those with lower baseline neuroticism (p = 0.027, d = -0.45). Those with higher baseline depression scores on the Depression Anxiety Stress Scale (DASS-21) had a smaller decrease in post-intervention MACCS Total Score relative to those with lower depression ratings. Conclusion: To our knowledge, this is the first feasibility study of its kind targeting perceptions of cognitive impairment during menopause. Although generally well-tolerated, recruitment and scheduling difficulties were flagged as challenges to engagement while a small sample size and lack of control group limit conclusions about efficacy. Providing current results could be replicated with enhanced methods, these results provide support that cognitive remediation is a feasible and credible treatment, and may improve quality of life for women in menopause. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03311880.

SUBMITTER: Ballantyne EC

PROVIDER: S-EPMC8733617 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAnorexia nervosa (AN) is a severe psychiatric condition characterized by low body weight, fear of weight gain/becoming fat and/or behavior that interferes with weight gain, and body disturbance. Though there have been recent advances in the treatment of AN, there continues to be an urgent need to increase treatment options. Cognitive remediation therapy (CRT) has been successfully used as an adjunctive treatment for individuals with AN. In this study, we pilot the use of CRT plus an innovative parent involvement component as a pre-treatment intervention on a medical unit. We hypothesize that adding CRT with parent involvement to a standard hospital stay is feasible, acceptable by patients and staff, and may improve treatment outcomes post-hospitalization.Methods/designThis is a pilot randomized controlled trial with three arms. Participants are adolescents aged 12-18 with AN; 60 participants will be included. They are randomized into one of three groups: treatment as usual (TAU, standard care at Children's Hospital of Philadelphia), CRT + contact control (known as "Family Fun Time"), and CRT + Teach the Parent. Intervention will occur on an inpatient basis. Follow-up will be outpatient and will continue until 6 months post-discharge. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study, and group differences will be evaluated at 4 weeks, 3 months, and 6 months post-discharge. The study will take place at The Children's Hospital of Philadelphia.DiscussionThis pilot randomized controlled trial will inform feasibility of the integration of a pre-treatment intervention into a medical hospital stay for AN. We will assess recruitment procedures, treatment administration, and participant retention. Finally, a comprehensive assessment battery will be evaluated. Secondary goals are to conduct a preliminary evaluation of whether or not CRT with parent involvement increases rate of weight gain and treatment engagement and decreases parental accommodation of symptoms post-discharge. If successful, this pilot study will inform a larger controlled trial fully powered to examine the secondary goals.Trial registrationClinicalTrials.gov Identifier NCT02883413.

Project description:Background:Most severe mental disorders have their onset between the age of 17 and 27, a time when many young adults begin participating in secondary or post-secondary education. The cognitive deficits typically associated with psychiatric disorders, especially psychotic disorders, increase the risk of leaving school early, which can lead to a reduction in employment opportunities later on in life and, in turn, a poorer long-term prognosis. Therefore, specific interventions aiming to improve these cognitive functions are needed. Cognitive remediation (CR) aims to improve cognitive functioning and may increase real-world functioning in educational performance. This study aims to examine the feasibility and applicability of a CR training named Mindset for students with psychotic disorders in the Netherlands. Methods/design:Sixty students diagnosed with a psychotic disorder and currently reporting cognitive deficits will be included from four Dutch Mental Health Care institutes. Half of the participants (N = 30) will be randomly assigned to the CR training consisting of twelve, individual, weekly 1-h meetings. The other half will be assigned to an active control condition consisting of twelve weekly assignments that will be sent by email aiming to improve school performance. Students will be evaluated at baseline (T0), directly after finishing the CR training or control intervention (T1), and 6 months later (T2). Treatment feasibility will be the primary outcome, using evaluation forms, interviews with trainers and participants, number of study drop outs, and patient eligibility and recruitment rates. School functioning, cognitive functioning, and strategy use will also be assessed to get a preliminary idea of the potential effectiveness of the intervention. Discussion:The CR training in this study will provide real-world examples and exercises aimed to teach useful strategies to cope with the cognitive deficits experienced by students with psychotic disorders. Furthermore, since students with other psychiatric disorders might also experience cognitive deficits, the results of this study may also provide some further implications for future studies on the effect of this CR training for students with these disorders. Trial registration:The study was registered with Trialregister.nl, no. NL6590 (NTR6764), date registered: September 7, 2017. Register name: Mindset. A cognitive rehabilitation training for young adults with psychotic spectrum disorder in an educational setting: A pilot study.Protocol version: 3, date December 23, 2019.

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Preliminary Support for a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study.

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