A Modified Behavioral Activation Treatment for Geriatric Depressive Symptoms in Left-behind Elderly in Rural China

May 24, 2016 updated by: The Third Xiangya Hospital of Central South University

Background: It is essential to understand how to prevent and treat the epidemic of depression. Several studies have reported the prevalence of depressive symptoms in the urban population in China, but there is a lack of information regarding intervention for depression in rural left behind old elderly people.

Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment (MBAT) Intervention on reducing depressive symptoms in rural left behind elderly people.

Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and control group(n=40). The intervention group will be received both MBAT and treatment-as-usual for 8 weeks while the control group received treatment-as-usual. Both groups will be assessed with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness Questionnaire (OHQ) at baseline, immediately post-intervention, and at 3 months post-intervention.

Significance: This is the first time BA psychotherapy will be used in China.The current study will develop an intention model based on the traditional BA and CBT. The recurrence and seriousness of depression symptoms may be reduced by the intervention program. We hope that MBAT in clients will provide a direction for the management of mental health in rural left-behind elders..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 65 years of age;
  • Only one participant from each family;
  • Left-behind for longer than 6 months;
  • GDS score between 11 and 25.

Exclusion Criteria:

  • Psychiatric and medical comorbidities that are potentially life threatening or expected to severely limit client participation or adherence;
  • Those who are currently seeing a cognitive behavioral therapist, psychotherapist or counselor;
  • People unable to understand and fill out the questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Behavioral Activation Treatment
The modified model will be provided weekly to four groups for intervention, each group including about 10 participants with 1 facilitator for a period of 8 weeks after the baseline survey and general introduction. Each of the 8-week sessions will last for 2 hours. Groups 1 to 4 will have sessions on Mondays, Tuesdays, Wednesdays, and Thursdays respectively; four groups will meet on the same day of the week for all 8 weeks. The scheduling and timing of intervention provide consistency of scheduling for participants.
Behavioral: Behavioral Activation Treatment
The modified model will be provided weekly to four groups for intervention, each group including about 10 participants with 1 facilitator for a period of 8 weeks after the baseline survey and general introduction. Each of the 8-week sessions will last for 2 hours. Groups 1 to 4 will have sessions on Mondays, Tuesdays, Wednesdays, and Thursdays respectively; four groups will meet on the same day of the week for all 8 weeks. The scheduling and timing of intervention provide consistency of scheduling for participants.
PLACEBO_COMPARATOR: control group
For the control group, participants will receive regular physical examinations and education by village doctors weekly during the 8 week intervention.The weekly visits for every old people whose age above 65 by country doctors are not arranged by our study, it is the country doctors" routine work by government health policy. This study was permitted by the local community health center, the director with specific responsibility will inform all country doctors to support our study.
Behavioral: Behavioral Activation Treatment
The modified model will be provided weekly to four groups for intervention, each group including about 10 participants with 1 facilitator for a period of 8 weeks after the baseline survey and general introduction. Each of the 8-week sessions will last for 2 hours. Groups 1 to 4 will have sessions on Mondays, Tuesdays, Wednesdays, and Thursdays respectively; four groups will meet on the same day of the week for all 8 weeks. The scheduling and timing of intervention provide consistency of scheduling for participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression assessed with the Geriatric Depression Scale
Time Frame: After 8 weeks MBAT, the GDS scores in the intervention group decreased significantly compared to those in the control group
Depression symptoms will be measured using the validated Chinese version of the Geriatric Depression Scale. The scale consists of 30 questions, used to screen for depressive symptoms in community-dwelling elderly to evaluate the effect of reminiscence on depressive symptoms.Questions ask elderly participants to describe feelings over the past week and responses are "Yes" or "No". Its ease of use makes it suitable for community studies. Scores from 0 to 10 are regarded as normal, 11-20 as mild depression, 21-25 as moderate depression, and 26-30 as severe depression. The internal consistency reliability of the scale was 0.89 and test-retest reliability was 0.85; criterion related validity was 0.95, and parallel validity using the center for Epidemiologic Studies Depression Scale (CES-D) was 0.96 in Chinese participants (Wang,1999).
After 8 weeks MBAT, the GDS scores in the intervention group decreased significantly compared to those in the control group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (ESTIMATE)

May 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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