Evidence map›Paper›PMID 33424715›Full record

ArticleFrontiers in psychology2020

Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI): Study Protocol of a Randomized Controlled Trial.

Urban Ekman, Mike K Kemani, John Wallert, Rikard K Wicksell, Linda Holmström, Tiia Ngandu, Anna Rennie, Ulrika Akenine, Eric Westman, Miia Kivipelto

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in psychology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04356924 (Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04356924 narecruitingnot on this mapstarted 2023, after this paper: background citation

Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)

TypeinterventionalSponsorKarolinska InstitutetRan2023 to 2028Enrolled138ConditionsCognitive Impairment, Psychological, Psychotherapy, Health BehaviorArmsPsychological treatment, Cognitive training
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

10 authors.

Urban EkmanCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.
Mike K KemaniMedical Unit Medical Psychology, Allied Health Professionals, Karolinska University Hospital, Stockholm, Sweden.
John WallertDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Rikard K WicksellDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Linda HolmströmMedical Unit Medical Psychology, Allied Health Professionals, Karolinska University Hospital, Stockholm, Sweden.
Tiia NganduCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.
Anna RennieCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.
Ulrika AkenineCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.
Eric WestmanCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.
Miia KivipeltoCenter for Alzheimer Research, Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues (including symptoms of stress, anxiety, and depression). The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention (Psychological Intervention tailored for Patients with Cognitive Impairment, PIPCI) manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial (RCT)-design and methods. The main hypothesis is that participants receiving PIPCI will increase their psychological flexibility (the ability to notice and accept interfering thoughts, emotions, and bodily sensations without acting on them, when this serves action in line with personal values) compared to participants in the active control (cognitive training) group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health (stress measures, quality of life, depression, and general health) compared to participants in the active control group and the waiting list control group. MATERIALS AND

methodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group (psychological intervention once a week for 10 weeks), an active control group (cognitive training once a week for 10 weeks) or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers (obtained from blood and saliva) and health care costs. Assessments will be performed at pre- (1 week before the interventions) and post-intervention (1 week after the interventions), as well as at a 6-month follow-up. DISCUSSION: The development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment (PIPCI) has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia. CLINICAL

trial registrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924.

Indexed as

acceptance commitment therapy (ACT)cognitive behavioral therapy (CBT)cognitive impairmentpreventionpsychological interventionrandomized controlled trial (RCT)

Identifiers

PMID33424715
PMCPMC7785936

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Registered trials

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.