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Combining cognitive remediation and metacognitive therapy for improving cognitive functions and reducing symptoms severity of adult patients with obsessive–compulsive disorder in Tehran, Iran: study protocol for a randomized, controlled trial

Ghazaleh Zargarinejad,Saba Mokhtari,Sara Mahdavi,Farah Bakizadeh,Shabnam Nohesara,Pouria Akbari Koli,Amir-Abbas Keshavarz-Akhlaghi,M. Shalbafan

Published 2025 in Trials

ABSTRACT

Patients with obsessive–compulsive disorder (OCD) experience various cognitive impairments, yet typical treatments do not address these deficits. Goal management training (GMT) is a structured cognitive remediation therapy to enhance executive function. GMT serves as a metacognitive strategy training, improving cognitive control and mindfulness related to executive dysfunction. Given OCD patients’ challenges with attention flexibility and control, the efficacy of GMT may be enhanced when combined with a preparatory intervention that builds foundational metacognitive knowledge. Metacognitive therapy (MCT), which targets maladaptive metacognitive beliefs linked to OCD symptoms, has been shown to enhance attentional flexibility and address cognitive deficits in these patients. This paper describes the protocol for a randomized controlled trial with a superiority framework that investigates the effectiveness of cognitive rehabilitation as a novel approach combining GMT-derived protocol and MCT for treating OCD. Thirty-six adult patients with a primary diagnosis of OCD will be randomly assigned to either an intervention group, an 8-week cognitive remediation group therapy, or an 8-week waitlist group. Participants will be recruited from Iran Psychiatry Hospital (a specialized psychiatric hospital) and the Brain and Cognition Clinic (an outpatient facility) in Tehran, Iran. Key inclusion criteria include aged 18–65 years and diagnosis of OCD. Exclusion criteria include comorbid severe mood or psychotic disorders, active medical comorbidity, or history of traumatic brain injury. Recruitment will commence on May 15, 2025. Participants will be randomly allocated in a 1:1 ratio to intervention or waitlist control. Randomization will not involve stratification variables. Researchers conducting assessments will be blinded to group allocation, therapists will be blinded to test results, data analysts will be independent of the intervention team, and participants will be instructed not to disclose group material to assessors. Clinical research assistants will recruit participants following diagnostic confirmation by psychiatrists. The initial three of the eight sessions will focus on MCT, and the last five will focus on GMT. Each session will last 2 h. Symptom severity of participants and multiple, separable cognitive aspects sensitive to OCD (attention and response inhibition, processing speed, planning, organization, problem-solving, verbal memory, and pre-morbid intellectual functioning) will be assessed at baseline, after treatment, and at a 3-month follow-up. The primary outcome will be changes in Yale-Brown Obsessive–Compulsive Scale (Y-BOCS; range 0–40, with higher scores indicating more severe symptoms) total, obsessive, and compulsive scores. Secondary outcomes will be performance scores on Conners’ continuous performance task (CPT), Stroop Color and Word Test (SCWT), and Tower of London (TOL). We hypothesize that this novel cognitive rehabilitation approach can positively impact cognitive deficits and reduce the severity of symptoms in adult patients with OCD. The trial was registered at the Iranian Registry of Clinical Trials on 19/01/2025 (https://irct.behdasht.gov.ir/trial/81348 (IRCT IRCT20170123032145N8)).

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