Improving thinking skills and reducing symptoms in adults with obsessive-compulsive disorder using combined cognitive and self-awareness therapy: a planned clinical trial in Tehran
Thirty-six adult patients with (OCD) will be enrolled in a randomized controlled trial to test a novel cognitive rehabilitation approach.
The trial will compare an 8-week cognitive remediation group therapy combining (GMT) and (MCT) with a waitlist control group.
Key cognitive aspects sensitive to OCD, such as attention flexibility and response inhibition, will be assessed at baseline, after treatment, and at a 3-month follow-up.
Primary outcomes will include changes in symptom severity measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).
Secondary outcomes will involve performance scores on tasks assessing cognitive functions, including attention and problem-solving.
The initial sessions will focus on MCT, while later sessions will concentrate on GMT.
Simplified
INTRODUCTION: Patients with (OCD) experience various cognitive impairments, yet typical treatments do not address these deficits. (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. (MCT), which targets maladaptive metacognitive beliefs linked to OCD symptoms, has been shown to enhance attentional flexibility and address cognitive deficits in these patients.
METHOD: 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).
CONCLUSION: We hypothesize that this novel cognitive rehabilitation approach can positively impact cognitive deficits and reduce the severity of symptoms in adult patients with OCD.
TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials on 19/01/2025 ( https://irct.behdasht.gov.ir/trial/81348 (IRCT IRCT20170123032145N8)).
Key numbers
36
Sample Size
Total participants planned for the study, considering dropout rates.
0.25
Expected Effect Size
Effect size anticipated for the primary outcome measure (Y-BOCS).
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Declarations. Ethics approval and consent to participate: The participants will provide written informed consent. The study has been registered and received ethical approval from the Medical Ethical Committee of the Iran University of Medical Sciences (IUMS) (protocol number IR.IUMS.FMD.REC.1403.025). The trial was registered at the Iranian Registry of Clinical Trials on 19/01/2025 ( www.irct.ir ; IRCT ID: IRCT IRCT20170123032145N8). This study will be conducted according to the declaration of Helsinki and subsequent revisions. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
