Dataset Information

Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR).

ABSTRACT:

Background

People with substance use disorders generally have unhealthy diets, including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on various indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy for opioid dependence. FruktBAR will compare the efficacy of added fruit smoothie supplementation to people receiving opioid agonist therapy compared to standard treatment without added supplementation.

Methods

FruktBAR is a multicentre, randomised controlled trial. The trial will aim to recruit 302 patients receiving opioid agonist therapy. The intervention involves daily supplementation with 250 ml fruit smoothie including a variety of fruits such as apple, pineapple, mango, bananas, orange, blueberries, passion fruit, coconut, lime, and blackcurrant. The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up during and after the intervention. The target group will be patients with opioid dependence receiving opioid agonist therapy from involved outpatient clinics in Bergen and Stavanger, two of the largest cities in Norway. The main outcome is psychological distress assessed with Hopkins Symptom Checklist (SCL-10) at the end of the intervention period 16 weeks after initiation, and will be compared between the intervention and control arms. Secondary outcome measures are changes in fatigue, physical functioning assessed with a 4-minute step-test, health-related quality of life, biochemical indicators of inflammation, and biochemical indicators of fruit intake.

Discussion

This study will inform on the relative advantages or disadvantages of fruit supplementation in addition to the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If the supplementation is efficacious, it can be considered for further scale-up.

Trial registration

Registered 2022-02-08 in ClinicalTrials.gov , identifier NCT05229770.

SUBMITTER: Fadnes LT

PROVIDER: S-EPMC9441043 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR).

Fadnes Lars T LT Furulund Einar E Druckrey-Fiskaaen Karl Trygve KT Madebo Tesfaye T Vold Jørn Henrik JH Olsvold Maria M Pierron Marianne Cook MC Carlsen Siv-Elin Leirvåg SL Blomhoff Rune R Lid Torgeir Gilje TG

BMC nutrition 20220903 1

<h4>Background</h4>People with substance use disorders generally have unhealthy diets, including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on various indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy for opioid dependence. FruktBAR will compare the efficacy of added fr ...[more]

PMID: 36057629

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Project description:BackgroundThe preliminary results of a randomised controlled trial are presented. The aim of the trial is to determine the efficacy, feasibility and acceptability of email-delivered psychological interventions with telephone support, for adults injured in a motor vehicle crash engaged in seeking compensation. The primary intention for this preliminary analysis was to investigate those who were psychologically distressed and to stop the trial midway to evaluate whether the safety endpoints were necessary.MethodsThe analysis included 90 adult participants randomised to one of three groups, who were assessed at baseline and post-intervention at 3 months. Cognitive behaviour therapy (CBT) or healthy lifestyle interventions were delivered over 10 weeks, involving fortnightly emailed modules plus clinically focussed telephone support, with the aim of reducing psychological distress. An active waiting list of control subjects received non-clinically focussed telephone contact over the same period along with claim-related reading material. Depression Anxiety Stress Scales (DASS) and Impact of Events Scale (Revised) (IES-R) were used to assess psychological distress. Psychiatric interviews were used to diagnose major depressive disorder and post-traumatic stress disorder. Aspects of acceptability and feasibility were also assessed.ResultsFor those diagnosed with depression at baseline in the CBT group, psychological distress reduced by around 16%. For those with depression in the healthy lifestyle group, distress increased marginally. For those in the control group with depression, distress also decreased (by 18% according to DASS-21 and 1.2% according to IES-R). For those without depression, significant reductions in distress occurred, regardless of group (P < .05). The results suggest that for those with depression, a healthy lifestyle intervention is contraindicated, necessitating the cessation of recruitment to this intervention. The interventions were reported as acceptable by the majority and the data indicated that the study is feasible.ConclusionsCBT with telephone support reduced psychological distress in physically injured people with depression who are engaged in seeking compensation. However, time plus fortnightly telephone contact with claim-related reading material may be sufficient to reduce distress in those who are depressed. For those who were not depressed, time plus telephone support is most likely sufficient enough to assist them to recover. The trial will continue with further recruitment to only the CBT and control groups, over longer follow-up periods.Trial registrationAustralian and New Zealand Clinical Trials Registry: Preventing psychological distress following a motor vehicle accident; ACTRN12615000326594 . Registered on 9 April 2015.

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Dataset Information

Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR).

Background

Methods

Discussion

Trial registration

Publications

Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR).

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