Dataset Information

Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv).

ABSTRACT:

Background

Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled trials on the effects of this among people with substance use disorder receiving opioid agonist therapy.

Methods

BAReAktiv is a multicentre randomized controlled trial. The study aims to recruit 324 patients receiving opioid agonist therapy (parallel groups randomized 1:1 to integrated exercise intervention or control, superiority trial). A 16-week group-based integrated exercise intervention with workouts twice a week. The exercise program consists of endurance and resistance training. The target group will be patients 18 years and older receiving opioid agonist therapy in outpatient clinics in several centers in Western Norway. The primary outcome of the study is the effect on psychological distress measured by Hopkins' symptom checklist with ten items. Secondary outcome measures include physical functioning assessed with a 4-min step test, activity level, fatigue symptoms, quality of life, and changes in inflammation markers. This study will provide improved knowledge on the effects of an integrated exercise program in opioid agonist therapy.

Discussion

Systematically integrating exercise programs for people receiving opioid agonist therapy could lead to a shift towards a stronger focus on health behaviors in outpatient care. Integrating exercise could benefit patient recovery and reduce disease burden. Further scale-up will be considered if the provided exercise program is safe and effective.

Trial registration

ClinicalTrials.gov. NCT05242848. Registered on February 16, 2022.

SUBMITTER: Furulund E

PROVIDER: S-EPMC10905828 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Publications

Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv).

Furulund Einar E Madebo Tesfaye T Druckrey-Fiskaaen Karl Trygve KT Vold Jørn Henrik JH Nordbotn Mette Hegland MH Dahl Eivin E Dyrstad Sindre M SM Lid Torgeir Gilje TG Fadnes Lars T LT

Trials 20240229 1

<h4>Background</h4>Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled trials on the effects of this among people with substance use disorder ...[more]

PMID: 38424609

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Project description:BackgroundUniversity students are at high risk of various mental health problems due to high levels of psychological distress. However, university counseling services are often inadequate to meet their mental health needs due to shortage of mental health professionals, especially in Hong Kong. Internet-based cognitive behavioral therapy (iCBT) has shown similar effects as those of face-to-face CBT in addressing these mental health concerns, but few iCBT programs have been developed for Hong Kong university students.ObjectiveThis study protocol aims to develop and evaluate a culturally and linguistically appropriate iCBT program called "REST Online" to reduce the psychological distress and improve the mental health of Chinese university students in Hong Kong in a randomized controlled trial (RCT).MethodThe contents and functionality of the "REST Online" program which includes both web- and app-based versions, are described. A blended mode of service delivery is adopted, with 8 online modules and 2 counseling sessions. Therapist support will be provided by a CBT therapist. A total of 338 Chinese university students with mild to moderate levels of psychological distress will be openly recruited and randomized to three groups: the (1) web-based and (2) app-based "REST Online" groups, and (3) waitlist control group. The program effectiveness is evaluated in psychological distress, depression and anxiety symptoms, and positive and negative emotions and positive and negative thoughts at pre-, post- and 3-month follow-up tests. Linear mixed effect models will be conducted for data analysis.DiscussionThe "REST Online" program is among the first of its kind to address the mental health needs of Hong Kong university students by an internet intervention. Theoretically, this study will provide some empirical evidence for the effectiveness of this iCBT program in the Hong Kong context for Chinese clients. Practically, if proven effective, this program can be provided to local university counselors as an option for service delivery. Strengths and limitations are also discussed.

Project description:BackgroundClinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.MethodsA randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.DiscussionThe trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.Trial registrationClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Project description:BackgroundDespite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care.ObjectiveWe intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer.MethodsThis will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures.ResultsA total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service.ConclusionsBizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden.Trial registrationClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595.International registered report identifier (irrid)DERR1-10.2196/24835.

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Dataset Information

Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv).

Background

Methods

Discussion

Trial registration

Publications

Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv).

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