LonelinessNCT04225845
The Economic Consequences of Loneliness Among the Elderly
A study testing Phone therapy and Cash transfer in people with Loneliness, run by National Bureau of Economic Research, Inc. at 1 site in India.
Trial summary
Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Phone therapy and Cash transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 55 years of age
- Individuals living alone
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve older individuals' mental wellbeing as well as ability to cover basic needs, particularly in times of COVID (including health). The first intervention will focus on improving the elderly's outlook on life and relationships through problem-solving therapy (PST) delivered over the phone. The second will deliver to them a one-time cash transfer of Rs.1000, equivalent to the emergency help amount distributed to ration card holder by the government of Tamil Nadu. Each intervention will be offered on its own in each of two treatment arms, and in combination in a third. A control group will receive no intervention. Investigators will track outcomes of the elderly at 3 weeks and 3 months after the intervention.
- Conditions
- Loneliness
- Being tested
- Phone therapy, Cash transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone therapyBehavioural
Weekly phone calls by lay trained personnel to deliver problem solving therapy.
Cash transferBehavioural
One-time cash transfer of Rs.1000.
| Study group | Role | What they receive |
|---|---|---|
| Phone therapy | Experimental | Weekly phone calls by lay trained personnel to deliver problem solving therapy. Receives: Behavioral: Phone therapy |
| Phone therapy plus cash transfer | Experimental | Weekly phone calls by lay trained personnel to deliver problem solving therapy. Combined with a one-time cash transfer of Rs.1000. Receives: Behavioral: Phone therapy; Behavioral: Cash transfer |
| Cash transfer | Experimental | One-time cash transfer of Rs.1000. Receives: Behavioral: Cash transfer |
| Control | No intervention | Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty in performing daily activities/Functional impairment score
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.
Measured: Assessed at 3 weeks after intervention
Difficulty in performing daily activities/Functional impairment score
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.
Measured: Assessed at 3 months after intervention
Mental health
The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.
Measured: Assessed at 3 weeks after intervention
Mental health
The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.
Measured: Assessed at 3 months after intervention
Food security
Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.
Measured: Assessed at 3 weeks after intervention
Food security
Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.
Measured: Assessed at 3 months after intervention
Secondary outcomes (18)
Seeking or receiving COVID vaccine
Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).
Measured: Assessed at 3 weeks after intervention
Seeking or receiving COVID vaccine
Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).
Measured: Assessed at 3 months after intervention
Loneliness
Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.
Measured: Assessed at 3 weeks after intervention
Loneliness
Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.
Measured: Assessed at 3 months after intervention
Healthcare utilization
Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).
Measured: Assessed at 3 weeks after intervention
Healthcare utilization
Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).
Measured: Assessed at 3 months after intervention
Survival of elderly person
Whether still living at time of follow-up survey (0/1 variable)
Measured: Assessed at 3 weeks after intervention
Survival of elderly person
Whether still living at time of follow-up survey (0/1 variable)
Measured: Assessed at 3 months after intervention
Social integration: non-family
This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).
Measured: Assessed at 3 weeks after intervention
Social integration: non-family
This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).
Measured: Assessed at 3 months after intervention
Social integration: family
This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).
Measured: Assessed at 3 weeks after intervention
Social integration: family
This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).
Measured: Assessed at 3 months after intervention
Cognitive function
Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.
Measured: Assessed at 3 weeks after intervention
Cognitive function
Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.
Measured: Assessed at 3 months after intervention
Consumption
Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.
Measured: Assessed at 3 weeks after intervention
Consumption
Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.
Measured: Assessed at 3 months after intervention
Health
This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.
Measured: Assessed at 3 weeks after intervention
Health
This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.
Measured: Assessed at 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Bureau of Economic Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Abdul Latif Jameel Poverty Action Lab
- Responsible party
- Principal investigator, Esther Duflo, National Bureau of Economic Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225845
- Sponsor's protocol ID
- 172020
- Other IDs
- P01AG005842
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2020
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKelway M, Banerjee A, Grela E, Schilbach F, Sequeira M, Sharma G, Vaidyanathan G, Duflo E. Effects of Cognitive Behavioral Therapy and Cash Transfers on Older Persons Living Alone in India : A Randomized Trial. Ann Intern Med. 2023 May;176(5):632-641. doi: 10.7326/M22-2496. Epub 2023 Apr 25.
PubMed 37094349
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economic Consequences of Loneliness Among the Elderly
- ClinicalTrials.gov ID
- NCT04225845
- Acronym / sponsor ID
- 172020
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- National Bureau of Economic Research, Inc.University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Abdul Latif Jameel Poverty Action Lab
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve older individuals' mental wellbeing as well as ability to cover basic needs, particularly in times of COVID (including health). The first intervention will focus on improving the elderly's outlook on life and relationships through problem-solving therapy (PST) delivered over the phone. The second will deliver to them a one-time cash transfer of Rs.1000, equivalent to the emergency help amount distributed to ration card holder by the government of Tamil Nadu. Each intervention will be offered on its own in each of two treatment arms, and in combination in a third. A control group will receive no intervention. Investigators will track outcomes of the elderly at 3 weeks and 3 months after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phone therapy | Experimental | Behavioral: Phone therapyWeekly phone calls by lay trained personnel to deliver problem solving therapy. |
| Phone therapy plus cash transfer | Experimental | Behavioral: Phone therapy, Behavioral: Cash transferWeekly phone calls by lay trained personnel to deliver problem solving therapy. Combined with a one-time cash transfer of Rs.1000. |
| Cash transfer | Experimental | Behavioral: Cash transferOne-time cash transfer of Rs.1000. |
| Control | No intervention | –Control group. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 55 years of age
- Individuals living alone
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone therapyWeekly phone calls by lay trained personnel to deliver problem solving therapy. | Behavioural | Phone therapy, Phone therapy plus cash transfer |
| Cash transferOne-time cash transfer of Rs.1000. | Behavioural | Cash transfer, Phone therapy plus cash transfer |
Primary outcome
Difficulty in performing daily activities/Functional impairment score
Time frame: Assessed at 3 weeks after intervention
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.
Difficulty in performing daily activities/Functional impairment score
Time frame: Assessed at 3 months after intervention
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.
Mental health
Time frame: Assessed at 3 weeks after intervention
The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.
Mental health
Time frame: Assessed at 3 months after intervention
The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.
Food security
Time frame: Assessed at 3 weeks after intervention
Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.
Food security
Time frame: Assessed at 3 months after intervention
Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.
18 secondary outcomes
Seeking or receiving COVID vaccine
Time frame: Assessed at 3 weeks after intervention
Seeking or receiving COVID vaccine
Time frame: Assessed at 3 months after intervention
Loneliness
Time frame: Assessed at 3 weeks after intervention
Loneliness
Time frame: Assessed at 3 months after intervention
Healthcare utilization
Time frame: Assessed at 3 weeks after intervention
Healthcare utilization
Time frame: Assessed at 3 months after intervention
Survival of elderly person
Time frame: Assessed at 3 weeks after intervention
Survival of elderly person
Time frame: Assessed at 3 months after intervention
Social integration: non-family
Time frame: Assessed at 3 weeks after intervention
Social integration: non-family
Time frame: Assessed at 3 months after intervention
Social integration: family
Time frame: Assessed at 3 weeks after intervention
Social integration: family
Time frame: Assessed at 3 months after intervention
Cognitive function
Time frame: Assessed at 3 weeks after intervention
Cognitive function
Time frame: Assessed at 3 months after intervention
Consumption
Time frame: Assessed at 3 weeks after intervention
Consumption
Time frame: Assessed at 3 months after intervention
Health
Time frame: Assessed at 3 weeks after intervention
Health
Time frame: Assessed at 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 37094349McKelway M, Banerjee A, Grela E, Schilbach F, Sequeira M, Sharma G, Vaidyanathan G, Duflo E. Effects of Cognitive Behavioral Therapy and Cash Transfers on Older Persons Living Alone in India : A Randomized Trial. Ann Intern Med. 2023 May;176(5):632-641. doi: 10.7326/M22-2496. Epub 2023 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone therapy and Cash transfer in people with Loneliness, run by National Bureau of Economic Research, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty in performing daily activities/Functional impairment score (time frame: Assessed at 3 weeks after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.