Intervention for Cognitive Difficulties in Depression

Not yet recruiting

• Conditions: Other depressive episodes,

• Registration Number: CTRI/2023/09/057529
• Lead Sponsor: Preeti Kodancha

Brief Summary

Depression is a common mental disorder as per the WorldHealth Organization (WHO). As per WHO estimates, about 5% of the adultpopulation in the world suffers from depression, amounting to 280 to 300million sufferers worldwide (WHO, 2021). Depression is characterized by thepresence of the hallmark features of low mood, decreased interest in previouslypleasurable activities, and easy fatiguability, and is often accompanied byother symptoms like persistent feelings of guilt, decreased self-esteem,decreased concentration and attention, ideas of self-harm and suicide,decreased appetite, and decreased sleep. One factor that isassociated to the impairment in Quality of Life in individuals with depressionis the cognitive deficits accompanying the diagnosis. Cognitive deficits are awell-documented and researched symptom cluster associated with depressivedisorders.

While cognitive symptoms of depression areparticularly debilitating, persist beyond affective symptom remission, andincrease risk of relapse, they are not targeted or resolved by evidence-basedpharmacotherapeutic and psychotherapeutic treatment. Existing cognitive training interventions whichtarget the cognitive symptoms.

- Are time and labour-intensive, posingsignificant challenges in the acceptability and feasibility of theinterventions.

- Do not focus on the broad generalization of thetreatment gains to everyday functioning.

- Do not emphasize the subjective perception ofcognitive deficits, and their contribution to disruption in socio-occupationalfunctioning.

In light of the above-highlighted gaps in the literature, the Integrated Cognitive Control Training (ICCT) intervention, a cognitive training intervention with components of cognitivestimulation, metacognitive strategy training, and generalization, originallydeveloped for OCD, offers viable promise for addressing all the lacunae inexisting interventions highlighted above.

- First, this intervention has previously beenadapted to be brief (originally developed as a 12-week intervention, and lateradapted to an eight-week format) and shown to be effective in the abbreviatedformat.

- Further, the intervention’s focus on buildingmetacognitive skills is a means to directly target the subjective perception ofcognitive deficits noted in depression.

- The intervention also places specific emphasison the generalization of treatment gains, with one component of theintervention exclusively dedicated to the same – current evidence does showthat the intervention does positively impact everyday functioning.

- Finally, existing literature shows that the ICCTleads to a decrease in depressive symptoms in OCD – this can be taken as thebasis to hypothesize that the intervention can be adapted to an interventionexclusive to the depressive symptoms; while the core components of theinterventions can be retained, the intervention itself can be abbreviated tocater to the milder cognitive deficits in depression as compared to OCD.

The current study is an attempt to adapt the ICCT as a briefintervention to address objectively assessed and subjectively perceivedcognitive deficits in depression and to test the feasibility of such anintervention in the depressive population.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 1.The individual must be between the ages of 18 years to 50 years.
• 2.The individual must have a minimum of 7th grade education.
• 3.The individual must be fluent in English, or Kannada.
• 4.The individual must be diagnosed as having a depressive episode, of mild/moderate/severe types as per the ICD-11 Diagnostic Criteria for Research.

Exclusion Criteria

• 1.The individual must not have psychotic or catatonic symptoms as a part of the depressive syndrome.
• 2.The individual must not be at serious risk of harm to self.
• 3.The individual must not have intellectual disability based on clinical observations.
• 4.The individual must not have any form of substance dependence (other than nicotine) 5.The individual must not have a history of neurological conditions such as tumours, epilepsy, stroke, traumatic brain injury, and degenerative disorders, or other severe psychiatric illness including Bipolar Affective Disorder and Psychotic illnesses.
• 6.The individual must not have any sensorimotor impairments on clinical examination or self-report, which may interfere with assessments/training.
• 7.The individual must not have undergone any structured psychological intervention of more than 3 sessions in the past 3 months.
• 8.The individual must not have received any form of brain stimulation in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived Deficits Questionnaire, Colour Trails Test - 2	Before Intervention, Within one week of intervention completion

Secondary Outcome Measures

Name	Time	Method
Metacognitive Awareness & Regulation Scale, Colour Trail Test – 1, Digit Span, Spatial Span, Controlled Oral Word Association Test, Hopkins Verbal Learning Test – Revised, Block Design Test, Stop Signal Task	Before Intervention, Within one week of intervention completion

Trial Locations

Locations (1)

National Institute of Mental Health and Neuro Sciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health and Neuro Sciences

🇮🇳Bangalore, KARNATAKA, India

Preeti Kodancha

Principal investigator

8310508371

preetikodancha.psych@gmail.com