DepressionCoviDepNCT04508868
Treatment of Depressive Symptoms in Older Individuals in Isolation During Covid-19
A study testing Brief Behavioral Activation with Mental Imagery in people with Depression and Depressive Symptoms, run by Uppsala University at 1 site in Sweden.
Trial summary
This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Depressive Symptoms
- What is being tested?
- Brief Behavioral Activation with Mental Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2020to 23 Dec 2020
- 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
- Residing in the County of Västmanland
- Access to telephone
- Fluent in written and spoken Swedish
- Reporting clinically significant depressive symptoms above cut-of on depression measures and/or by structured clinical interview
Who cannot join
- Severe depression
- Elevated risk of suicide
- Current substance use disorder
- Current or previous manic/hypomanic episodes
- Current psychotic disorder
- Current diagnosis of dementia/major neurocognitive disorder
- Currently receiving psychological therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Activation and Mental Imagery Delivered Via Telephone for the Treatment of Depressive Symptoms in Older Individuals in Isolation During Covid-19: A Randomized Clinical Trial
This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Two therapeutic methods are used in combination during this intervention: Behavioral activation (BA) and Mental Imagery (MI). BA involves identifying and scheduling enjoyable and meaningful activities to improve mood and reduce social isolation. To enhance BA efficacy and adherence, MI is paired with BA as MI is known to activate emotion and motivation. The MI intervention in this study involves having participants imagine, in vivid sensory detail, engaging in some of the activities that are scheduled during BA.
Approximately 154 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving the intervention after 4 weeks. This procedure makes it possible to evaluate the effects of the treatment while not disadvantaging participants randomized to the control group. Participants will be asked to fill in questionnaires before, during (at the end of each intervention week), and after treatment (or waiting period for the control group). Questionnaires will also be sent 1-, 3- and 6 months after treatment to follow up on the results. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.
Read the detailed description
Coronavirus (COVID-19) has become a worldwide pandemic. The mortality rates are highest in the older age groups, particularly in those 70 years and older. In Sweden, the government urges people 70 years and older to limit close contact with other people and to stay at home as much as possible, a strategy called social distancing. From previous epidemics, such as the SARS-epidemic, we know that quarantine and isolation leads to psychological symptoms such as stress, irritability, depressed mood and sleep problems. About 30% of those subjected to isolation and quarantine become depressed, and in a study from Hong Kong during SARS there was a nearly 32% increase of suicide rates among individuals 65 years and older. In Sweden, depression among the elderly was a major public health concern before the covid-19-pandemic - Major depression occurred in 5-15 % of the older population in Sweden, and one third of the women and a fifth of the men 65 years and older reported subclinical depressive symptoms. Several mental health experts raise concerns that there will be an increase of psychiatric illness during and after covid-19, particularly among the elderly.
Depression in older individuals can be treated with antidepressant medication, psychological interventions and physical activity. However, the majority of the older individuals state that they would prefer psychological treatments to medication, which poses a challenge during COVID-19 as such treatments are often delivered face-to-face. Psychological treatments delivered via the Internet are as efficacious as face-to-face, but only 3-4% of the individuals 65 years and above in Sweden use digital applications that replace physical healthcare visits.
Psychological treatments have been shown to work when delivered via telephone, and since practically every household in Sweden has access to a telephone, the investigators believe this could be a feasible option. Preferably, the treatment should be brief yet effective, and easily accessible for healthcare professionals. One such treatment is brief behavioral activation (BA), which is aimed at increasing enjoyable and meaningful activities to improve mood. BA has been shown to be feasible in as few as four sessions. Depression is often accompanied by low motivation and lack of energy, which can pose a problem when trying to increase activities. One way of increasing motivation in BA and the likelihood of performing the planned activities is to add mental imagery (MI), where some of these activities are imagined in detail during the calls.
However, there are to the investigators knowledge no studies of telephone-delivered brief BA for older individuals, no studies of the combination of BA and MI for depression in the elderly, and no studies of either of these during pandemics with isolation or quarantine.
The aim of the present study is to investigate the feasibility, effect and experience of telephone-delivered Behavioral Activation with Mental Imagery for the treatment of depressive symptoms in individuals 65 years and older during the covid-19-pandemic.
- Conditions
- Depression, Depressive Symptoms
- Being tested
- Brief Behavioral Activation with Mental Imagery, Minimal Attention Control Intervention
- Keywords
- Depression, Depressive Symptoms, Cognitive Behavioral Therapy, Social Isolation, Coronavirus, Pandemic
- Medical subject headings
- Depression, Social Isolation, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Activation with Mental ImageryBehavioural
Session 1:
Provide psychoeducation about depression; Provide treatment rationale for BA; Provide rationale and instructions for activity log; Plan activities for coming week.
Session 2:
Review activity log; Discuss life goals and values; Plan activities aligned with life goals and values for coming week; Provide rationale for Mental Imagery (MI); Go through MI-exercise for one of the planned activities.
Session 3:
Review activity log; Troubleshoot any problems carrying out activities; Plan activities aligned with life goals and values for coming week; Go through MI-exercise for one of the planned activities.
Session 4:
Review activity log; Troubleshoot any problems carrying out activities; Review treatment; Stress the importance of continuing to engage in activities aligned with life goals and values; Referral to additional services if necessary.
Minimal Attention Control InterventionBehavioural
Weekly call with follow-up of psychiatric symptoms and assessment of suicide risk.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Activation with Mental Imagery | Experimental | Four weekly sessions of Brief Behavioral Activation with Mental Imagery. Receives: Behavioral: Brief Behavioral Activation with Mental Imagery |
| Minimal Attention Control Intervention | Placebo comparator | Four weeks with weekly follow-up calls. Receives: Behavioral: Minimal Attention Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S
MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54.
Measured: Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Secondary outcomes (8)
Change from baseline in depressive symptoms using the Geriatric Depression Rating Scale 15, GDS-15
GDS-15 is a 15-item questionnaire used to identify depression in the elderly. The score ranges from 0-15.
Measured: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in depressive symptoms using the Patient Health Questionnaire 9, PHQ-9
PHQ-9 is a nine-item questionnaire used to identify depression as well as measuring severity of depression. The score ranges from 0-27.
Measured: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI
MINI is a structured clinical interview used to assess the presence/absence of common psychiatric disorders.
Measured: Baseline; Intervention Week 4.
Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item, GAD-7
GAD-7 is a seven-item questionnaire used to identify generalized anxiety disorder as well as measuring severity of anxiety symptoms. The score ranges from 0-21.
Measured: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in behavioral activation using The Behavioral Activation for Depression Scale - Short Form, BADS-SF
BADS-SF is a nine-item questionnaire used to measure changes in avoidance and activation. The score ranges from 0-54.
Measured: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS
WHODAS-12 is a 12-item questionnaire used to assess disability due to health conditions. The total score ranges from 0-48.
Measured: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Adverse and unwanted effects of the experimental intervention using the Negative Effects Questionnaire, NEQ
NEQ is a 20-item questionnaire used to assess adverse and unwanted effects of psychological treatments.
Measured: Experimental Intervention Week 4.
Mental imagery is assessed at baseline using the Plymouth Sensory Imagery Questionnaire, Psi-Q
Psi-Q is a 35-item questionnaire assessing the vividness of mental imagery. In this study we plan to use the visual subscale with five items, with a total score ranging from 0-50.
Measured: Baseline; Intervention Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start31 Aug 2020
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Why it stopped: Study terminated due to changes in government restrictions. Collected data to be presented as a pilot study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Mattias Damberg, MD, PhD, Principal investigator, County of Vastmanland and Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508868
- Sponsor's protocol ID
- 2020-02079
- Acronym
- CoviDep
- Status last verified
- Dec 2020
- First submitted
- 10 Aug 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified outcome measure IPD will be shared upon reasonable requests from academic researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and Mental Imagery Delivered Via Telephone for the Treatment of Depressive Symptoms in Older Individuals in Isolation During Covid-19: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04508868
- Acronym / sponsor ID
- CoviDep / 2020-02079
- Conditions
- Depression, Depressive Symptoms
- Keywords
- Depression, Depressive Symptoms, Cognitive Behavioral Therapy, Social Isolation, Coronavirus, Pandemic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to changes in government restrictions. Collected data to be presented as a pilot study.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- 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.
This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Two therapeutic methods are used in combination during this intervention: Behavioral activation (BA) and Mental Imagery (MI). BA involves identifying and scheduling enjoyable and meaningful activities to improve mood and reduce social isolation. To enhance BA efficacy and adherence, MI is paired with BA as MI is known to activate emotion and motivation. The MI intervention in this study involves having participants imagine, in vivid sensory detail, engaging in some of the activities that are scheduled during BA.
Approximately 154 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving the intervention after 4 weeks. This procedure makes it possible to evaluate the effects of the treatment while not disadvantaging participants randomized to the control group. Participants will be asked to fill in questionnaires before, during (at the end of each intervention week), and after treatment (or waiting period for the control group). Questionnaires will also be sent 1-, 3- and 6 months after treatment to follow up on the results. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.
Detailed description
Coronavirus (COVID-19) has become a worldwide pandemic. The mortality rates are highest in the older age groups, particularly in those 70 years and older. In Sweden, the government urges people 70 years and older to limit close contact with other people and to stay at home as much as possible, a strategy called social distancing. From previous epidemics, such as the SARS-epidemic, we know that quarantine and isolation leads to psychological symptoms such as stress, irritability, depressed mood and sleep problems. About 30% of those subjected to isolation and quarantine become depressed, and in a study from Hong Kong during SARS there was a nearly 32% increase of suicide rates among individuals 65 years and older. In Sweden, depression among the elderly was a major public health concern before the covid-19-pandemic - Major depression occurred in 5-15 % of the older population in Sweden, and one third of the women and a fifth of the men 65 years and older reported subclinical depressive symptoms. Several mental health experts raise concerns that there will be an increase of psychiatric illness during and after covid-19, particularly among the elderly.
Depression in older individuals can be treated with antidepressant medication, psychological interventions and physical activity. However, the majority of the older individuals state that they would prefer psychological treatments to medication, which poses a challenge during COVID-19 as such treatments are often delivered face-to-face. Psychological treatments delivered via the Internet are as efficacious as face-to-face, but only 3-4% of the individuals 65 years and above in Sweden use digital applications that replace physical healthcare visits.
Psychological treatments have been shown to work when delivered via telephone, and since practically every household in Sweden has access to a telephone, the investigators believe this could be a feasible option. Preferably, the treatment should be brief yet effective, and easily accessible for healthcare professionals. One such treatment is brief behavioral activation (BA), which is aimed at increasing enjoyable and meaningful activities to improve mood. BA has been shown to be feasible in as few as four sessions. Depression is often accompanied by low motivation and lack of energy, which can pose a problem when trying to increase activities. One way of increasing motivation in BA and the likelihood of performing the planned activities is to add mental imagery (MI), where some of these activities are imagined in detail during the calls.
However, there are to the investigators knowledge no studies of telephone-delivered brief BA for older individuals, no studies of the combination of BA and MI for depression in the elderly, and no studies of either of these during pandemics with isolation or quarantine.
The aim of the present study is to investigate the feasibility, effect and experience of telephone-delivered Behavioral Activation with Mental Imagery for the treatment of depressive symptoms in individuals 65 years and older during the covid-19-pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Activation with Mental Imagery | Experimental | Behavioral: Brief Behavioral Activation with Mental ImageryFour weekly sessions of Brief Behavioral Activation with Mental Imagery. |
| Minimal Attention Control Intervention | Placebo comparator | Behavioral: Minimal Attention Control InterventionFour weeks with weekly follow-up calls. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Residing in the County of Västmanland
- Access to telephone
- Fluent in written and spoken Swedish
- Reporting clinically significant depressive symptoms above cut-of on depression measures and/or by structured clinical interview
Key exclusion criteria (7 listed)
- Severe depression
- Elevated risk of suicide
- Current substance use disorder
- Current or previous manic/hypomanic episodes
- Current psychotic disorder
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 |
|---|---|---|
| Brief Behavioral Activation with Mental ImagerySession 1: Provide psychoeducation about depression; Provide treatment rationale for BA; Provide rationale and instructions for activity log; Plan activities for coming week. Session 2: Review activity log; Discuss life goals and values; Plan activities aligned with life goals and values for coming week; Provide rationale for Mental Imagery (MI); Go through MI-exercise for one of the planned activities. Session 3: Review activity log; Troubleshoot any problems carrying out activities; Plan activities aligned with life goals and values for coming week; Go through MI-exercise for one of the planned activities. Session 4: Review activity log; Troubleshoot any problems carrying out activities; Review treatment; Stress the importance of continuing to engage in activities aligned with life goals and values; Referral to additional services if necessary. | Behavioural | Brief Behavioral Activation with Mental Imagery |
| Minimal Attention Control InterventionWeekly call with follow-up of psychiatric symptoms and assessment of suicide risk. | Behavioural | Minimal Attention Control Intervention |
Primary outcome
Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S
Time frame: Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54.
8 secondary outcomes
Change from baseline in depressive symptoms using the Geriatric Depression Rating Scale 15, GDS-15
Time frame: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in depressive symptoms using the Patient Health Questionnaire 9, PHQ-9
Time frame: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI
Time frame: Baseline; Intervention Week 4.
Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item, GAD-7
Time frame: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in behavioral activation using The Behavioral Activation for Depression Scale - Short Form, BADS-SF
Time frame: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS
Time frame: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.
Adverse and unwanted effects of the experimental intervention using the Negative Effects Questionnaire, NEQ
Time frame: Experimental Intervention Week 4.
Mental imagery is assessed at baseline using the Plymouth Sensory Imagery Questionnaire, Psi-Q
Time frame: Baseline; Intervention Week 4.
Results and safety
The study was stopped early (reason given: Study terminated due to changes in government restrictions. Collected data to be presented as a pilot study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: Yes. De-identified outcome measure IPD will be shared upon reasonable requests from academic researchers.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Mattias Damberg, MD, PhD principal investigator
County of Vastmanland and Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation with Mental Imagery in people with Depression and Depressive Symptoms, run by Uppsala University at 1 site in Sweden.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Dec 2020. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study terminated due to changes in government restrictions. Collected data to be presented as a pilot study.). Results are not available in the source record.
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?
Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S (time frame: Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2020.