CTRI Number |
CTRI/2023/09/057529 [Registered on: 13/09/2023] Trial Registered Prospectively |
Last Modified On: |
05/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Single Arm Study |
Public Title of Study
|
Intervention for Cognitive Difficulties in Depression |
Scientific Title of Study
|
Adaptation and Feasibility of a Brief, Integrated Cognitive Control Training Intervention for Depression |
Trial Acronym |
Not Applicable |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Preeti Kodancha |
Designation |
Trainee |
Affiliation |
National Institute of Mental Health and Neuro Sciences |
Address |
3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
08310508371 |
Fax |
|
Email |
preetikodancha.psych@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Himani Kashyap |
Designation |
Associate Professor |
Affiliation |
National Institute of Mental Health and Neuro Sciences |
Address |
3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
7760230223 |
Fax |
|
Email |
drhimanikashyap@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Preeti Kodancha |
Designation |
Trainee |
Affiliation |
National Institute of Mental Health and Neuro Sciences |
Address |
3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
08310508371 |
Fax |
|
Email |
preetikodancha.psych@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore |
|
Primary Sponsor
|
Name |
Preeti Kodancha |
Address |
3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Preeti Kodancha |
National Institute of Mental Health and Neuro Sciences |
3rd Floor, Dept of Clinical Psychology, NIMHANS, Hombegowda Nagar, Bangalore Bangalore KARNATAKA |
8310508371
preetikodancha.psych@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee (Behavioural Sciences Division) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F328||Other depressive episodes, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Integrated Cognitive Control Training Intervention |
The ICCT is a cognitive training intervention that was originally developed for OCD (Kashyap et al., 2019). The targets of the intervention included cognitive control and goal-directed flexible adjustments of behaviour. The intervention was based on Bowie et al.’s (2015) ‘Three Pillars of Cognitive Training’ described above. The intervention consists of components of cognitive stimulation, metacognitive strategy monitoring, and generalization.
The intervention was first conducted as a 12-week program with therapist-guided sessions once a week and additional homework sessions over two months. A case report of this intervention on a 29-year-old revealed improvements in various aspects of executive functioning (predominantly in verbal fluency and planning), along with improvement in depressive and anxiety-related symptoms. Importantly, the intervention led to improvement in subjectively perceived cognitive difficulties, and improved functionality across occupational and interpersonal (Kashyap et al., 2019). The intervention was also adapted as an eight-week, 24 hours program for patients with remitted OCD (Rini et al., 2019) – a preliminary study showed that the intervention group demonstrated significant improvements compared to the control group with moderate to large effect sizes. Most importantly, these results were found to generalize to other untrained cognitive, clinical and socio-occupational domains – hence, unlike existing interventions, the ICCT was able to demonstrate a broad transfer of effects. This eight-week program for patients with OCD (Bhattacharya, Kashyap, & Reddy, 2022) was later also found to bring about significant improvements in cognitive and executive deficits in a sample of 38 OCD patients, and the improvement was noted in different domains of everyday functioning, which was maintained at three-months follow-up, once again demonstrating a broad transfer of effects and treatment generalization to everyday functionality. |
Comparator Agent |
NOT APPLICABLE - SINGLE ARM STUDY |
NOT APPLICABLE - SINGLE ARM STUDY |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
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. |
|
ExclusionCriteria |
Details |
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. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Perceived Deficits Questionnaire, Colour Trails Test - 2 |
Before Intervention, Within one week of intervention completion |
|
Secondary Outcome
|
Outcome |
TimePoints |
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 |
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/10/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Depression is a common mental disorder as per the World
Health Organization (WHO). As per WHO estimates, about 5% of the adult
population in the world suffers from depression, amounting to 280 to 300
million sufferers worldwide (WHO, 2021). Depression is characterized by the
presence of the hallmark features of low mood, decreased interest in previously
pleasurable activities, and easy fatiguability, and is often accompanied by
other 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 is
associated to the impairment in Quality of Life in individuals with depression
is the cognitive deficits accompanying the diagnosis. Cognitive deficits are a
well-documented and researched symptom cluster associated with depressive
disorders.
While cognitive symptoms of depression are
particularly debilitating, persist beyond affective symptom remission, and
increase risk of relapse, they are not targeted or resolved by evidence-based
pharmacotherapeutic and psychotherapeutic treatment. Existing cognitive training interventions which
target the cognitive symptoms. - Are time and labour-intensive, posing
significant challenges in the acceptability and feasibility of the
interventions.
- Do not focus on the broad generalization of the
treatment gains to everyday functioning.
- Do not emphasize the subjective perception of
cognitive deficits, and their contribution to disruption in socio-occupational
functioning.
In light of the above-highlighted gaps in the literature, the Integrated Cognitive Control Training (ICCT) intervention, a cognitive training intervention with components of cognitive
stimulation, metacognitive strategy training, and generalization, originally
developed for OCD, offers viable promise for addressing all the lacunae in
existing interventions highlighted above. - First, this intervention has previously been
adapted to be brief (originally developed as a 12-week intervention, and later
adapted to an eight-week format) and shown to be effective in the abbreviated
format.
- Further, the intervention’s focus on building
metacognitive skills is a means to directly target the subjective perception of
cognitive deficits noted in depression.
- The intervention also places specific emphasis
on the generalization of treatment gains, with one component of the
intervention exclusively dedicated to the same – current evidence does show
that the intervention does positively impact everyday functioning.
- Finally, existing literature shows that the ICCT
leads to a decrease in depressive symptoms in OCD – this can be taken as the
basis to hypothesize that the intervention can be adapted to an intervention
exclusive to the depressive symptoms; while the core components of the
interventions can be retained, the intervention itself can be abbreviated to
cater to the milder cognitive deficits in depression as compared to OCD.
The current study is an attempt to adapt the ICCT as a brief
intervention to address objectively assessed and subjectively perceived
cognitive deficits in depression and to test the feasibility of such an
intervention in the depressive population. |