Dataset Information

Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples.

ABSTRACT: OBJECTIVE:The objective of this study was to test the short-term efficacy of a brief, fully manualized marital communication and interpersonal support intervention for couples facing recently diagnosed breast cancer. METHODS:A total of 322 women diagnosed within 6 months with stages 0 to III breast cancer and their 322 spouse caregivers were enrolled. Spouses in the experimental group received five 30- to 60-minute intervention sessions at 2-week intervals by master's-prepared patient educators; controls received the booklet, "What's Happening to the Woman I Love?" Outcomes were assessed at 3, 6, and 9 months using the linear mixed models within an intent-to-treat analysis. RESULTS:Compared with controls, at 3 months, spouse caregivers significantly improved on standardized measures of depressed mood, anxiety, cancer-related marital communication, interpersonal support, and self-care. All differences except depressed mood and anxiety were sustained at 9 months. Wives significantly improved at 3 months on marital communication and positive appraisal of spouses' interpersonal support; gains remained significant at 9 months. Compared with controls on chemotherapy, wives in the experimental group additionally improved on depressed mood and tended to improve on anxiety. CONCLUSIONS:A brief, fully manualized intervention delivered directly to spouse caregivers early in the course of their wives' medical treatment improves caregivers' self-care and behavioral-emotional adjustment and wives' positive view of their spouses' support and communication. The brevity and manualized structure of the intervention argue strongly for its scalability, use in cost-sensitive settings, and its potential dissemination through e-health channels.

SUBMITTER: Lewis FM

PROVIDER: S-EPMC6483880 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples.

Lewis Frances Marcus FM Griffith Kristin A KA Alzawad Zainab Z Dawson Patricia L PL Zahlis Ellen H EH Shands Mary Ellen ME

Psycho-oncology 20181228 2

<h4>Objective</h4>The objective of this study was to test the short-term efficacy of a brief, fully manualized marital communication and interpersonal support intervention for couples facing recently diagnosed breast cancer.<h4>Methods</h4>A total of 322 women diagnosed within 6 months with stages 0 to III breast cancer and their 322 spouse caregivers were enrolled. Spouses in the experimental group received five 30- to 60-minute intervention sessions at 2-week intervals by master's-prepared pat ...[more]

PMID: 30549145

Similar Datasets

Project description:BackgroundEnhancing physical activity in overweight and obese individuals is an important means to promote health in this target population. The Health Action Process Approach (HAPA), which was the theoretical framework of this study, focuses on individual self-regulation variables for successful health behavior change. One key self-regulation variable of this model is action control with its three subfacets awareness of intentions, self-monitoring and regulatory effort. The social context of individuals, however, is usually neglected in common health behavior change theories. In order to integrate social influences into the HAPA, this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity.Methods/designThis protocol describes the design of a single-blind randomized controlled trial, which comprises four experimental groups: a dyadic action control group, an individual action control group and two control groups. Participants of this study are overweight or obese, heterosexual adult couples who intend to increase their physical activity. Blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition. The ecological momentary intervention takes place in the first 14 days after baseline assessment and is followed by another 14 days diary phase without intervention. Follow-ups are one month and six months later. Subsequent to the six-months follow-up another 14 days diary phase takes place.The main outcome measures are self-reported and accelerometer-assessed physical activity. Secondary outcome measures are Body Mass Index (BMI), aerobic fitness and habitual physical activity.DiscussionThis is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial. Challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed. This RCT was funded by the Swiss National Science Foundation (PP00P1_133632/1) and was registered on 27/04/2012 at http://www.isrctn.com/ISRCTN15705531.

Project description:BackgroundMajor depressive disorder (MDD) is often comorbid with metabolic diseases such as obesity, cardiovascular disease, and type 2 diabetes. A potential link between these disorders is adiponectin, an adipocyte-derived circulating hormone with insulin-sensitizing, anti-inflammatory, and neuroplasticity effects. Reductions in plasma levels of adiponectin have been reported in both humans with depression and in the chronic-defeat mouse model of depression. However, the predictive value of adiponectin for treatment response to depression has not been determined.MethodsWe investigated the potential predictive effect of baseline adiponectin levels in patients who provided plasma and were undergoing one of three pharmacological treatments (escitalopram monotherapy; escitalopram plus bupropion; and venlafaxine plus mirtazapine) in the Combining Medications to Enhance Depression Outcomes clinical trial (n=160). Specifically, we assessed whether adiponectin moderates-that is, differentially predicts-treatment response among the treatment arms. Improvements with treatment were assessed using change in the clinician-rated 30-item Inventory of Depressive Symptomatology (IDS-C) from baseline through week 12. Moderator effects were tested using separate pairwise repeated measures mixed-effects models with a treatment-arm-by-adiponectin interaction.ResultsBaseline adiponectin levels moderated treatment outcome between two combination therapies. Specifically, low adiponectin predicted better response to escitalopram plus bupropion compared to venlafaxine plus mirtazapine, whereas high adiponectin predicted better response to venlafaxine plus mirtazapine compared to escitalopram plus bupropion (F=4.84, p=0.03). Adiponectin levels did not correlate with baseline depression severity (r=-0.03, p=.59).ConclusionsAntidepressant selection for patients with MDD can be personalized using pre-treatment blood-based biomarkers, such as adiponectin, thereby improving treatment outcomes.

Project description:Hospitalization provides an opportunity for smokers to quit, but tobacco-cessation interventions started in hospital must continue after discharge to be effective. This study aimed to improve the scalability of a proven effective post-discharge intervention by incorporating referral to a telephone quitline, a nationally available cessation resource.A three-site RCT compared Sustained Care, a post-discharge tobacco-cessation intervention, with Standard Care among hospitalized adult smokers who wanted to quit smoking and received in-hospital tobacco-cessation counseling.A total of 1,357 daily smokers admitted to three hospitals were enrolled from December 2012 to July 2014.Sustained Care started at discharge and included automated interactive voice response telephone calls and the patient's choice of cessation medication for 3 months. Each automated call advised cessation, supported medication adherence, and triaged smokers seeking additional counseling or medication support directly to a telephone quitline. Standard Care provided only medication and counseling recommendations at discharge.Biochemically confirmed past 7-day tobacco abstinence 6 months after discharge (primary outcome) and self-reported tobacco abstinence and tobacco-cessation treatment use at 1, 3, and 6 months and overall (0-6 months). Analyses were done in 2015-2016.Smokers offered Sustained Care (n=680), versus those offered Standard Care (n=677), did not have greater biochemically confirmed abstinence at 6 months (17% vs 16%, p=0.58). However, the Sustained Care group reported more tobacco-cessation counseling and medication use at each follow-up and higher rates of self-reported past 7-day tobacco abstinence at 1 month (43% vs 32%, p<0.0001) and 3 months (37% vs 30%, p=0.008). At 6 months, the difference narrowed (31% vs 27%, p=0.09). Overall, the intervention increased self-reported 7-day abstinence over the 6-month follow-up (relative risk, 1.25; 95% CI=1.10, 1.40; p=0.0006).A 3-month post-discharge smoking-cessation intervention for hospitalized smokers who wanted to quit did not increase confirmed tobacco abstinence at 6 months but did increase self-reported abstinence during the treatment period (3 months). Real-time linkage of interactive voice response calls to a quitline, done in this trial to increase scalability of a previously proven cessation intervention, demonstrated short-term promise but did not sustain long-term intervention effectiveness.This study is registered at www.clinicaltrials.gov NCT01714323.

Dataset Information

Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples.

Publications

Helping Her Heal: Randomized clinical trial to enhance dyadic outcomes in couples.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets