Evidence map›Paper›PMID 36109030›Full record

ArticleBMJ open2022

ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes.

Eileen Bendig, Andreas Schmitt, Amelie Wittenberg, Bernhard Kulzer, Norbert Hermanns, Morten Moshagen, Harald Baumeister

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Eileen BendigDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany eileen.bendig@uni-ulm.de.ORCID 0000-0001-6727-1751
Andreas SchmittResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.ORCID 0000-0002-5913-1457
Amelie WittenbergDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.
Bernhard KulzerResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
Norbert HermannsResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.ORCID 0000-0002-2903-2677
Morten MoshagenDepartment of Research Methods, Institute of Psychology and Education, University of Ulm, Ulm, Germany.ORCID 0000-0002-2929-7288
Harald BaumeisterDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.
Universität Ulm · DEGerman Diabetes Center Mergentheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLiving with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) 'ACTonDiabetes' in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care. METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2-4 weeks after hospital discharge and takes about 7-10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated. ETHICS AND DISSEMINATION: This clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00016738.

Indexed as

Acceptance and Commitment TherapyDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2AdultHumansInternetPatient Health QuestionnairePragmatic Clinical Trials as TopicQuality of Lifeclinical trialsdepression & mood disordersgeneral diabetes

Identifiers

PMID36109030
PMCPMC9478835
OpenAlexW4295922522

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.