Cognitive control training for depression
| ISRCTN | ISRCTN13666367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13666367 |
- Submission date
- 11/09/2019
- Registration date
- 24/09/2019
- Last edited
- 11/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a mental health condition where a person feels constantly very sad and low in mood for two weeks or more. It affects people in different ways. Sufferers can feel hopeless, anxious and lose interest in doing things they used to enjoy. It can also lead to problems with sleeping, feeling constantly tired, a loss of appetite and a low sex drive. In the most extreme cases, it can result in a person harming themselves or attempting to take their own life (suicide). The study aims to compare two treatment methods for depression, cognitive control training and behavioural activation
Who can participate?
Patients aged 18 – 50 with major depressive disorder
What does the study involve?
Participants are randomly allocated into Cognitive Control Training (CCT) or the active control group (Behavioral Activation). They are assessed with questionnaires a before and after the 18-session intervention (twice weekly).
What are the possible benefits and risks of participating?
Possible benefits of participating in this study include improvement in their condition and relief from symptoms. Improvement in cognitive and mood symptoms is likely. The intervention will target mood regulation and long-term sustainable strategies to deal with depression. The study doctor/researcher will be monitoring participants' condition more closely than usual. The findings of this study will be helpful in developing new strategies for patients with depression. There are no costs to participants and they will not be paid for their participation. The tests, examination and treatment will be free of cost. There are no risks involved in the treatment, but since the treatment requires participants to not change the dose of medication a month before and 3 months after the intervention there could be worsening of symptoms, in such a case they will be independently assessed by a psychiatrist and will be removed from the study.
Where is the study run from?
1. NIMHANS OPD
2. NIMHANS Centre for Well Being (NCWB)
When is the study starting and how long is it expected to run for?
October 2017 to October 2019
Who is funding the study?
National Institute of Mental Health and Neuroscience (India)
Who is the main contact?
Meenakshi Banerjee
meenakshi.banerjee@gmail.com
Contact information
Public
225 Cauvery Hostel
NIMHANS
Hosur Road
Bangalore
560029
India
 ORCID ID |
0000-0001-9883-9004 |
|---|---|
| Phone | +91 (0)8197292827 |
| meenakshi.banerjee@gmail.com |
Study information
| Study design | Randomised controlled trial with single-blind pre-post and follow up design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Cognitive control training for depression: a randomised controlled trial |
| Study acronym | CCT-D |
| Study objectives | Hypothesis 1: There will be no difference in measures of depression, anxiety, emotion regulation, metacognition, neuro-cognitions and quality of life, before and after cognitive control training Hypothesis 2: There will be no difference in measures of depression, anxiety, emotion regulation, metacognition, neuro-cognitions and quality of life, between patients who recieve cognitive control training and behavioural activation |
| Ethics approval(s) | Approved 18/07/2016, NIMHANS (Human) Ethics Committee (National Institute for Mental Health and Neuroscience (NIMHANS), Hosur Road, Hombegowda Nagar, Bangalore, India; +91 (0) 8026995000; ms@nimhans.ac.in), ref: NIMH/DO/ETHICS SUB-COMMITTEE29thMEETING/2016 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Allocation to groups was done with a computer-generated random number table. Arm 1 (Intervention) Cognitive Control Training: 18 sessions (twp per week) training executive control processes - working memory, response inhibition and mental flexibility keeping an affective framework to suit patients with depression and decrease rumination and improve metacognition. Arm 2 (Control) Behavioural Activation: 18 sessions (two per week) behaviour activation adapted from Jacobson (2001) and suggestions by Veale et al (2007). Post-intervention CGI (Clinical Global Index) was done by an expert blind rater. |
| Intervention type | Behavioural |
| Primary outcome measure | Depression measured using Beck's Depression Inventory (BDI) at baseline and 9 weeks |
| Secondary outcome measures | 1. Illness severity measured using the Clinical Global Index (CGI) at baseline and 9 weeks 2. Neuro-cognitive measures at baseline and 9 weeks: 2.1. Spatial Span 2.2. Digit Span (WMS III) |
| Overall study start date | 01/10/2017 |
| Completion date | 15/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Major Depressive Disorder (as primary diagnosis) 2. Score of 17 or above on Beck’s Depression Inventory (BDI) 3. Age range of 18-50 years 4. Comprehension of written and spoken English/Hindi 5. Right handedness 6. Normal or corrected vision or hearing 7. Stable on medication dosage for one month |
| Key exclusion criteria | 1. History suggestive of neurological, neurosurgical conditions and /or history of head injury And/or mental retardation on clinical assessment 2. Diagnosis of schizophrenia, Bipolar Affective Disorder, Severe Depression with psychotic symptoms, Delusional disorder, current psychoactive substance abuse and/or dependence (except nicotine) 3. Any structured psychological intervention in the past 6 months 4. Any neurocognitive intervention and/or neuropsychological assessments 5. Have received ECT (in last 6 months) |
| Date of first enrolment | 01/10/2017 |
| Date of final enrolment | 10/09/2019 |
Locations
Countries of recruitment
- India
- United Kingdom
Study participating centres
Hombegowda Nagar
Bangalore
Karnataka
560029
India
Stage, BTM Layout 1
Bengaluru
Karnataka
560076
United Kingdom
Sponsor information
Government
Hosur Road
Hombegowda Nagar
Bangalore
560029
India
| Phone | +91 (0)8026995000 |
|---|---|
| ms@nimhans.ac.in | |
| Website | http://www.nimhans.ac.in |
"ROR" |
https://ror.org/0405n5e57 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication 1: Letter to author/correspondence regarding usefulness of affective material for Cognitive Control Training for Depression Publication 2: Literature review of CCT in Depression Publication 3: Methodology Publication 4: Final paper with results of the trial |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
11/10/2019: Total final enrolment number added.
19/09/2019: Trial's existence confirmed by ethics committee.
