Evidence map›Paper›PMID 35164720›Full record

ArticleBMC psychiatry2022

Randomised controlled trial of Interpersonal and Social Rhythm Therapy and group-based Cognitive Remediation versus Interpersonal and Social Rhythm Therapy alone for mood disorders: study protocol.

Katie M Douglas, Maree L Inder, Marie T Crowe, Jennifer Jordan, Dave Carlye, Cameron Lacey, Ben Beaglehole, Roger Mulder, Kate Eggleston, Katherine A Donovan and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

13 authors.

Katie M DouglasDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand. katie.douglas@otago.ac.nz.
Maree L InderDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Marie T CroweDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Jennifer JordanDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Dave CarlyeDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Cameron LaceyDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Ben BeagleholeDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Roger MulderDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Kate EgglestonDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Katherine A DonovanDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Christopher M A FramptonDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Christopher R BowieDepartment of Psychology, Queen's University, Kingston, ON, Canada.
Richard J PorterDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndividuals with mood disorders frequently experience cognitive impairment, which impacts on the long-term trajectory of the disorders, including being associated with persisting difficulties in occupational and psychosocial functioning, residual mood symptoms, and relapse. Current first-line treatments for mood disorders do little to improve cognitive function. Targeting cognition in clinical research is thus considered a priority. This protocol outlines a prospectively-registered randomised controlled trial (RCT) which examines the impact of adding group-based Cognitive Remediation (CR) to Interpersonal and Social Rhythm Therapy (IPSRT-CR) for individuals with mood disorders.

methodsThis is a pragmatic, two-arm, single-blinded RCT comparing IPSRT-CR with IPSRT alone for adults (n = 100) with mood disorders (Major Depressive Disorder or Bipolar Disorder) with subjective cognitive difficulties, on discharge from Specialist Mental Health Services in Christchurch, New Zealand. Both treatment arms will receive a 12-month course of individual IPSRT (full dose = 24 sessions). At 6 months, randomisation to receive, or not, an 8-week group-based CR programme (Action-based Cognitive Remediation - New Zealand) will occur. The primary outcome will be change in Global Cognition between 6 and 12 months (treatment-end) in IPSRT-CR versus IPSRT alone. Secondary outcomes will be change in cognitive, functional, and mood outcomes at 6, 12, 18, and 24 months from baseline and exploratory outcomes include change in quality of life, medication adherence, rumination, and inflammatory markers between treatment arms. Outcome analyses will use an intention-to-treat approach. Sub-group analyses will assess the impact of baseline features on CR treatment response. Participants' experiences of their mood disorder, including treatment, will be examined using qualitative analysis. DISCUSSION: This will be the first RCT to combine group-based CR with an evidence-based psychotherapy for adults with mood disorders. The trial may provide valuable information regarding how we can help promote long-term recovery from mood disorders. Many issues have been considered in developing this protocol, including: recruitment of the spectrum of mood disorders, screening for cognitive impairment, dose and timing of the CR intervention, choice of comparator treatment, and choice of outcome measures.

trial registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12619001080112 . Registered on 6 August 2019.

Indexed as

Bipolar DisorderCognitive RemediationMajor Depressive DisorderAdultAustraliaHumansPragmatic Clinical Trials as TopicPsychotherapyRandomized Controlled Trials as TopicBipolar DisorderCognitive impairmentCognitive remediationMajor Depressive DisorderPsychotherapyRandomised Controlled TrialTrial protocol

Identifiers

PMID35164720
PMCPMC8845377

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Registered trials

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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.