DepressionPhase 2NCT01553669
Reminiscence Therapy on Depression, Self Esteem, Life Satisfaction, and Loneliness of the Elderly
A Phase 2 study testing reminiscence therapy in people with Depression, run by Chinese Academy of Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- reminiscence therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age and older;
- A score above 10 and lower than 26 on the Geriatric Depression Scale (GDS);
- A score of 24 or higher on the Mini-Mental State Examination (MMSE);
- 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;
- 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).
Who cannot join
- Suicide attempt;
- A diagnosis of cognitive impairment by DSM-Ⅳ, or mental disorders other than depression;
- Alcohol or drug abuse;
- Cannot grantee attending the therapy at a weekly base due to physical impairment, lack of time or unwilling etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Sciences, Institute of Psychology, Center on Ageing Psychology, Key Lab of Mental Health
Beijing, Beijing Municipality, 100101
Tingji Chen, master, (086)18610249921, Chentj@psych.ac.cn
Juan Li, PhD, (086)010-64861622, lijuan@psych.ac.cn
About this study
Official title: The Effects of Reminiscence Therapy on Depression, Self Esteem, Life Satisfaction, and Loneliness of the Elderly in China
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.
Read the detailed 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
- Conditions
- Depression
- Being tested
- reminiscence therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminiscence therapyBehavioural
Also called life review
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.
| Study group | Role | What they receive |
|---|---|---|
| reminiscence therapy | Experimental | Reminiscence therapy is a method of using the memory to protect mental health and improve the quality of life. Receives: Behavioral: reminiscence therapy |
| Control group | No intervention | The participants assigned to the waiting-list as the control group will be treated as before. After the intervention period, we will conduct reminiscence therapy on them if they ask for. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression using the Geriatric Depression Scale(GDS)
Measured: the 6th and 18th week
Secondary outcomes (3)
Change in self esteem using the Self-Esteem Scale (SES)
Measured: the 6th and 18th week
Change in life satisfaction using the Life Satisfaction Index A (LSI-A)
Measured: the 6th and 18th week
Change in loneliness using Russell's UCLA Loneliness Scale
Measured: the 6th and 18th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
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 DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Juan, Chinese Academy of Sciences
- Investigators
- Juan Li, PhD, Principal investigator, Chinese Acad Sci, Inst Psychol, Ctr Ageing Psychol, Key Lab Mental Hlth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553669
- Sponsor's protocol ID
- 2009BAI77B03
- Status last verified
- May 2012
- First submitted
- 6 Mar 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen TJ, Li HJ, Li J. The effects of reminiscence therapy on depressive symptoms of Chinese elderly: study protocol of a randomized controlled trial. BMC Psychiatry. 2012 Nov 5;12:189. doi: 10.1186/1471-244X-12-189.
PubMed 23126676
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reminiscence Therapy on Depression, Self Esteem, Life Satisfaction, and Loneliness of the Elderly in China
- ClinicalTrials.gov ID
- NCT01553669
- Acronym / sponsor ID
- 2009BAI77B03
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- 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.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reminiscence therapy | Experimental | Behavioral: reminiscence therapyReminiscence therapy is a method of using the memory to protect mental health and improve the quality of life. |
| Control group | No intervention | –The participants assigned to the waiting-list as the control group will be treated as before. After the intervention period, we will conduct reminiscence therapy on them if they ask for. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years of age and older;
- A score above 10 and lower than 26 on the Geriatric Depression Scale (GDS);
- A score of 24 or higher on the Mini-Mental State Examination (MMSE);
- 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;
- 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).
Key exclusion criteria (4 listed)
- Suicide attempt;
- A diagnosis of cognitive impairment by DSM-Ⅳ, or mental disorders other than depression;
- Alcohol or drug abuse;
- Cannot grantee attending the therapy at a weekly base due to physical impairment, lack of time or unwilling etc.
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 |
|---|---|---|
| reminiscence therapyAlso: life reviewThe 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. | Behavioural | reminiscence therapy |
Primary outcome
Change in depression using the Geriatric Depression Scale(GDS)
Time frame: the 6th and 18th week
3 secondary outcomes
Change in self esteem using the Self-Esteem Scale (SES)
Time frame: the 6th and 18th week
Change in life satisfaction using the Life Satisfaction Index A (LSI-A)
Time frame: the 6th and 18th week
Change in loneliness using Russell's UCLA Loneliness Scale
Time frame: the 6th and 18th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Derived from this study: PubMed 23126676Chen TJ, Li HJ, Li J. The effects of reminiscence therapy on depressive symptoms of Chinese elderly: study protocol of a randomized controlled trial. BMC Psychiatry. 2012 Nov 5;12:189. doi: 10.1186/1471-244X-12-189.
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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.
Juan Li, PhD principal investigator
Chinese Acad Sci, Inst Psychol, Ctr Ageing Psychol, Key Lab Mental Hlth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reminiscence therapy in people with Depression, run by Chinese Academy of Sciences at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2012. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingji Chen, master ((086)18610249921, Chentj@psych.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression using the Geriatric Depression Scale(GDS) (time frame: the 6th and 18th week). 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 NCT01553669, 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 15 May 2012.