NCT04225845

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

January 7, 2020

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Assessed at 3 months after intervention

Secondary Outcomes (18)

  • Seeking or receiving COVID vaccine

    Assessed at 3 weeks after intervention

  • Seeking or receiving COVID vaccine

    Assessed at 3 months after intervention

  • Loneliness

    Assessed at 3 weeks after intervention

  • Loneliness

    Assessed at 3 months after intervention

  • Healthcare utilization

    Assessed at 3 weeks after intervention

  • +13 more secondary outcomes

Study Arms (4)

Phone therapy

EXPERIMENTAL

Weekly phone calls by lay trained personnel to deliver problem solving therapy.

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.

Behavioral: Phone therapyBehavioral: Cash transfer

Cash transfer

EXPERIMENTAL

One-time cash transfer of Rs.1000.

Behavioral: Cash transfer

Control

NO INTERVENTION

Control group.

Interventions

Phone therapyBEHAVIORAL

Weekly phone calls by lay trained personnel to deliver problem solving therapy.

Phone therapyPhone therapy plus cash transfer
Cash transferBEHAVIORAL

One-time cash transfer of Rs.1000.

Cash transferPhone therapy plus cash transfer

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 55 years of age
  • Individuals living alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JPAL SA at IFMR

Chennai, Tamil Nadu, India

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate, NBER; Abdul Latif Jameel Professor of Poverty Alleviation and Development Economics, MIT

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations