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

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785211
• Other study ID #: S181
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: May 24, 2016
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial Summary

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Health Behavior

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

References & Publications (3)

Dimidjian S, Barrera M Jr, Martell C, Muñoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535. Review. — View Citation

Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. — View Citation

Dobson KS, Hollon SD, Dimidjian S, Schmaling KB, Kohlenberg RJ, Gallop RJ, Rizvi SL, Gollan JK, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the prevention of relapse and recurrence in major depression. J Consult Clin Psychol. 2008 Jun;76(3):468-77. doi: 10.1037/0022-006X.76.3.468. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depression assessed with the Geriatric Depression Scale	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	Yes