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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01553669
Other study ID # 2009BAI77B03
Secondary ID
Status Recruiting
Phase Phase 2
First received March 6, 2012
Last updated May 14, 2012
Start date October 2011
Est. completion date September 2012

Study information

Verified date May 2012
Source Chinese Academy of Sciences
Contact Tingji Chen, master
Phone (086)18610249921
Email Chentj@psych.ac.cn
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical Trial Summary

The primary hypothesis is, comparing with the control group, reminiscence therapy is significantly and clinically effective to improve the experiment group's depressive symptoms after six weeks therapy, and the efficacy can be maintained on the three months follow-up.

The secondary hypothesis is, comparing with the control group, reminiscence therapy significantly reduce the loneliness and increase the self-esteem and life satisfaction of the experiment group.


Description:

The subjects who are arranged to the experiment group will be intervened using the reminiscence therapy manual proposed by Watt and Cappeliez (2000). According to the manual, the group consisted of six weekly sessions of 90 min each. During each weekly session, the memories recalled focused on a different theme.

Data collection will occur on screening (as for baseline or pre-test), after intervention immediately (as for post-test), and three months after the intervention (as for follow-up). And outcome measures use standardized instruments with demonstrated validity and reliability:

Geriatric Depression Scale (GDS) Rosenberg self-esteem scale (SES) Life Satisfaction Index A (LSI-A) Russell's UCLA Loneliness Scale


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

1. 60 years of age and older;

2. A score above 10 and lower than 26 on the Geriatric Depression Scale (GDS);

3. A score of 24 or higher on the Mini-Mental State Examination (MMSE);

4. Not taking anti-depressant medication or taking part in other psychotherapy when enrolling, if taking anti-depressant medication, must be stabilized on that medication for at least three months;

5. Having no problem with communication (such as, can speak fluent mandarin, or if he/she speaks a dialect, his/her dialect can be understood by most of people).

Exclusion Criteria:

1. Suicide attempt;

2. A diagnosis of cognitive impairment by DSM-?, or mental disorders other than depression;

3. Alcohol or drug abuse;

4. Cannot grantee attending the therapy at a weekly base due to physical impairment, lack of time or unwilling etc.

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
reminiscence therapy
The subjects who are arranged to the experiment group will be intervened using the reminiscence therapy manual proposed by Watt and Cappeliez (2000). According to the manual, the group consisted of six weekly sessions of 90 min each. There will be about four people in each subgroup. During each weekly session, the memories recalled focused on a different theme.

Locations

Country Name City State
China Chinese Academy of Sciences, Institute of Psychology, Center on Ageing Psychology, Key Lab of Mental Health Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in depression using the Geriatric Depression Scale(GDS) the 6th and 18th week Yes
Secondary Change in self esteem using the Self-Esteem Scale (SES) the 6th and 18th week Yes
Secondary Change in life satisfaction using the Life Satisfaction Index A (LSI-A) the 6th and 18th week Yes
Secondary Change in loneliness using Russell's UCLA Loneliness Scale the 6th and 18th week Yes
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