Reminiscence TherapyNOBITSNCT02077153
Nostalgia Bits (NOBITS)
A study testing Reminiscence therapy and Active participation in group setting in people with Reminiscence Therapy, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Reminiscence group therapy is a brief and structured intervention that has been shown to be effective for improving well-being among older adults. Reminiscence helps accepting the ageing process by solving unresolved issues and past losses; the group setting empowers the efficacy of the process by giving back to… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Reminiscence Therapy
- What is being tested?
- Reminiscence therapy and Active participation in group setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2012to Jun 2014
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age, or older.
- Hospitalized elderly
Who cannot join
- Major depressive symptoms, as indicated by a minimum score of 17 on GDS.
- Cognitive impairment, as indicated by a maximum score of 21 of MMSE that corresponds to mild dementia.
- Currently receiving any other psychological treatment for improving wellbeing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nostalgia Bits Project
Reminiscence group therapy is a brief and structured intervention that has been shown to be effective for improving well-being among older adults. Reminiscence helps accepting the ageing process by solving unresolved issues and past losses; the group setting empowers the efficacy of the process by giving back to elderly a way to manage their skills in a wider setting and interact with other people. The sharing of memories reinforces the identity through active tasks, preparing individuals to cope with the final part of the life. However, considering reminiscence interventions for older populations, controlled trials adopting better inclusion/exclusion criteria, standardized measures, and different conditions for comparing the effect are needed.
According to this premise, the trial presents the design of a randomized controlled aimed at comparing group reminiscence therapy with a group recreational activity in a older population. It includes two groups of approximately 20 hospitalized elderly: (1) the Experimental Group, (2) the Control Group. Participants included in the Experimental Group will receive a group reminiscence therapy of six sessions, while the Control Group will participate in a recreational group discussion. Between design with repeated measures will be used to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, quality of life across baseline, post-intervention and three months post-intervention.
What the investigators would like to show with the present trial is the efficacy of a group reminiscence intervention in a hospitalized population of older adults: focusing on specific past events and re-living them in a group environment may enhance the self-esteem and quality of life better than a simple group discussion.
Read the detailed description
The present trial is based on a randomized controlled study. The investigators will recruited 40 participants, including two groups of at least 20 hospitalized elderly: 1) the experimental group 2) the control group. Participants included in the experimental condition will take part to group reminiscence therapy sessions, while the control group will take part to recreational group discussions. Psychometric outcomes will serve as quantitative dependent variables.
A group setting lead by two psychologists is planned for both conditions. Each meeting will last 60 minutes and 6 participant will take part to it. The real setting will be the nursing home: a comfortable room will be provided, accessible also to wheel-chairs, participants will sit in circle. The involvement of each participant is encouraged, trying to stimulate the discussion/debate in a positive atmosphere. Personal critics, moral judgments or political statements are stopped.
Following, a description of the protocol in details for the experimental and the control group.
- In the experimental condition, everything begins ensuring the participants that all the memories shared will not be spread out of the group. Every session will deal with a theme, recalling specific autobiographic experiences; they will be suggested following a chronological order. Participants are encouraged to bring photos or objects related to past themes: at the end of each meeting the theme of the following is revealed. The researchers can also bring materials as cues for reminiscence.
- In the control condition, Every meeting will offer topics for discussion taken from newspaper and newscasts: personal opinions are promoted, and links with the daily life of participants are welcome (everyday activities, personal preferences). The main goal is to stimulate the social interaction and the communication, without dealing with personal events from the past nor private memories.
3-months follow up is planned in order to verify the efficacy of the training over time.
- Conditions
- Reminiscence Therapy
- Being tested
- Reminiscence therapy, Active participation in group setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence therapyBehavioural
Active participation in group settingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group Reminescence | Experimental | In the experimental condition, everything begins ensuring the participants that all the memories shared will not be spread out of the group. Every session will deal with a theme, recalling specific autobiographic experiences; they will be suggested following a chronological order. Participants are encouraged to bring photos or objects related to past themes: at the end of each meeting the theme of the following is revealed. The researchers can also bring materials as cues for reminiscence. Receives: Behavioral: Reminiscence therapy |
| Group discussion | Active comparator | In the control condition, every meeting will offer topics for discussion taken from newspaper and newscasts: personal opinions are promoted, and links with the daily life of participants are welcome (everyday activities, personal preferences). The main goal is to stimulate the social interaction and the communication, without dealing with personal events from the past nor private memories. Receives: Behavioral: Active participation in group setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of reminiscence effect on psychological well-being
Measured: 6 weeks
Secondary outcomes (1)
Reminiscence function
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionJun 2014
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 Reminiscence TherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Riva, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077153
- Sponsor's protocol ID
- 03A901
- Other IDs
- AAL-2009-2-131
- Acronym
- NOBITS
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gaggioli A, Scaratti C, Morganti L, Stramba-Badiale M, Agostoni M, Spatola CA, Molinari E, Cipresso P, Riva G. Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial. Trials. 2014 Oct 25;15:408. doi: 10.1186/1745-6215-15-408.
PubMed 25344703
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nostalgia Bits Project
- ClinicalTrials.gov ID
- NCT02077153
- Acronym / sponsor ID
- NOBITS / 03A901
- Conditions
- Reminiscence Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Mar 2014 (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.
Reminiscence group therapy is a brief and structured intervention that has been shown to be effective for improving well-being among older adults. Reminiscence helps accepting the ageing process by solving unresolved issues and past losses; the group setting empowers the efficacy of the process by giving back to elderly a way to manage their skills in a wider setting and interact with other people. The sharing of memories reinforces the identity through active tasks, preparing individuals to cope with the final part of the life. However, considering reminiscence interventions for older populations, controlled trials adopting better inclusion/exclusion criteria, standardized measures, and different conditions for comparing the effect are needed.
According to this premise, the trial presents the design of a randomized controlled aimed at comparing group reminiscence therapy with a group recreational activity in a older population. It includes two groups of approximately 20 hospitalized elderly: (1) the Experimental Group, (2) the Control Group. Participants included in the Experimental Group will receive a group reminiscence therapy of six sessions, while the Control Group will participate in a recreational group discussion. Between design with repeated measures will be used to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, quality of life across baseline, post-intervention and three months post-intervention.
What the investigators would like to show with the present trial is the efficacy of a group reminiscence intervention in a hospitalized population of older adults: focusing on specific past events and re-living them in a group environment may enhance the self-esteem and quality of life better than a simple group discussion.
Detailed description
The present trial is based on a randomized controlled study. The investigators will recruited 40 participants, including two groups of at least 20 hospitalized elderly: 1) the experimental group 2) the control group. Participants included in the experimental condition will take part to group reminiscence therapy sessions, while the control group will take part to recreational group discussions. Psychometric outcomes will serve as quantitative dependent variables.
A group setting lead by two psychologists is planned for both conditions. Each meeting will last 60 minutes and 6 participant will take part to it. The real setting will be the nursing home: a comfortable room will be provided, accessible also to wheel-chairs, participants will sit in circle. The involvement of each participant is encouraged, trying to stimulate the discussion/debate in a positive atmosphere. Personal critics, moral judgments or political statements are stopped.
Following, a description of the protocol in details for the experimental and the control group.
- In the experimental condition, everything begins ensuring the participants that all the memories shared will not be spread out of the group. Every session will deal with a theme, recalling specific autobiographic experiences; they will be suggested following a chronological order. Participants are encouraged to bring photos or objects related to past themes: at the end of each meeting the theme of the following is revealed. The researchers can also bring materials as cues for reminiscence.
- In the control condition, Every meeting will offer topics for discussion taken from newspaper and newscasts: personal opinions are promoted, and links with the daily life of participants are welcome (everyday activities, personal preferences). The main goal is to stimulate the social interaction and the communication, without dealing with personal events from the past nor private memories.
3-months follow up is planned in order to verify the efficacy of the training over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Reminescence | Experimental | Behavioral: Reminiscence therapyIn the experimental condition, everything begins ensuring the participants that all the memories shared will not be spread out of the group. Every session will deal with a theme, recalling specific autobiographic experiences; they will be suggested following a chronological order. Participants are encouraged to bring photos or objects related to past themes: at the end of each meeting the theme of the following is revealed. The researchers can also bring materials as cues for reminiscence. |
| Group discussion | Active comparator | Behavioral: Active participation in group settingIn the control condition, every meeting will offer topics for discussion taken from newspaper and newscasts: personal opinions are promoted, and links with the daily life of participants are welcome (everyday activities, personal preferences). The main goal is to stimulate the social interaction and the communication, without dealing with personal events from the past nor private memories. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age, or older.
- Hospitalized elderly
Key exclusion criteria (3 listed)
- Major depressive symptoms, as indicated by a minimum score of 17 on GDS.
- Cognitive impairment, as indicated by a maximum score of 21 of MMSE that corresponds to mild dementia.
- Currently receiving any other psychological treatment for improving wellbeing.
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 therapy | Behavioural | Group Reminescence |
| Active participation in group setting | Behavioural | Group discussion |
Primary outcome
Evidence of reminiscence effect on psychological well-being
Time frame: 6 weeks
1 secondary outcome
Reminiscence function
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 25344703Gaggioli A, Scaratti C, Morganti L, Stramba-Badiale M, Agostoni M, Spatola CA, Molinari E, Cipresso P, Riva G. Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial. Trials. 2014 Oct 25;15:408. doi: 10.1186/1745-6215-15-408.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence therapy and Active participation in group setting in people with Reminiscence Therapy, run by Istituto Auxologico Italiano at 1 site in Italy.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Aug 2018. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of reminiscence effect on psychological well-being (time frame: 6 weeks). 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 NCT02077153, 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 29 Aug 2018.