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Control condition design and implementation features in controlled trials: a meta-analysis of trials evaluating psychotherapy for depression
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ABSTRACT: Control conditions are the primary methodology used to reduce threats to internal validity in randomized controlled trials (RCTs). This meta-analysis examined the effects of control arm design and implementation on outcomes in RCTs examining psychological treatments for depression. A search of MEDLINE, PsycINFO, and EMBASE identified all RCTs evaluating psychological treatments for depression published through June 2009. Data were analyzed using mixed-effects models. One hundred twenty-five trials were identified yielding 188 comparisons. Outcomes varied significantly depending control condition design (p < 0.0001). Significantly smaller effect sizes were seen when control arms used manualization (p = 0.006), therapist training (p = 0.002), therapist supervision (p = 0.009), and treatment fidelity monitoring (p = 0.003). There were no significant effects for differences in therapist experience, level of expertise in the treatment delivered, or nesting vs. crossing therapists in treatment arms. These findings demonstrate the substantial effect that decisions regarding control arm definition and implementation can have on RCT outcomes.
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“Meta-analytic findings suggest the type of comparator has a material impact on the magnitude of pooled effects (Gold 2017;Michopoulos 2021;Mohr 2014).”
From Exercise for the treatment of anxiety in children and adolescents (2022) · cites this paper as Mohr 2014
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“As control conditions can dramatically impact effect sizes observed in RCTs of psychological interventions generally58,59 and mHealth RCTs specifically44, considering control conditions to be a single category is typically not defensible.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [59]
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“Importantly, it appears that a carefully matched non-specific control condition has not been used in previous studies [22, 23, 28, 51, 55]”
From Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial (2023) · cites this paper as [28]
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Metadata
- Authors
- Mohr, D. C., Ho, J., Hart, T. L., Baron, K. G., Berendsen, M., Beckner, V., Cai, X., Cuijpers, P., Spring, B., Kinsinger, S. W., Schroder, K. E., & Duffecy, J.
- Affiliations
- Northwestern University (US)
- Toronto Metropolitan University (CA)
- University of California, San Francisco (US)
- Vrije Universiteit Amsterdam (NL)
- Corresponding author
- Mohr, David C
- ORCID
- Venue
- Translational Behavioral Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-05-02
- Volume
- 4
- Issue
- 4
- Pages
- 407-423
- ISSN
- 1613-9860 (ISSN-L)
- 1869-6716
- PMC
- PMC4286544
- OpenAlex
- W2015937454
- Cited by
- 139
- References
- 31
- Citations by year
- 2026: 8 · 2025: 15 · 2024: 18 · 2023: 12 · 2022: 14 · 2021: 17 · 2020: 12 · 2019: 17 · 2018: 10 · 2017: 4 · 2016: 5 · 2015: 6 · 2014: 1
- FWCI
- 0.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Translational Behavioral Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- VU Research Portal (publishedVersion)
- Multilingual Matters (Channel View Publications) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- National Institute of Mental Health (R01MH095753, R01MH059708)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- control conditions, depression, psychotherapy, psychological intervention, internal validity, manualization, therapist training, therapist supervision, therapist experience
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