Internet TreatmentALMNCT05269524
ICBT for Depression in Older Adults
A study testing Internet-delivered tailored cognitive behavior therapy in people with Internet Treatment and Active Control, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study was a randomized controlled trial investigating treatment effects against an active control condition. 101 self-recruited participants, aged 65 to 88 years, were included. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Internet Treatment, Active Control
- What is being tested?
- Internet-delivered tailored cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2016to 30 Jun 2018
- 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
- age 65 years or older
- presence of depressive symptoms
- living in Sweden
- access to the internet and a computer on a regular basis.
Who cannot join
- heightened suicidal ideation
- drug or alcohol abuse or dependency
- other ongoing psychological treatment
- severe psychiatric or cognitive problems
- unstable psychopharmacological medication
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: TAILORED INTERNET-DELIVERED COGNTIVE BEHAVIOR THERAPY FOR DEPRESSED OLDER ADULTS: A RANDOMIZED TRIAL
The study was a randomized controlled trial investigating treatment effects against an active control condition. 101 self-recruited participants, aged 65 to 88 years, were included. The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes.
Read the detailed description
Depression in older adults is associated with poorer functioning, worsened cognitive impairment and disability, as well as medical illnesses. It can also increase the risk of suicide and is associated with a high usage of medical services. It is common that depressive symptoms co-occur with other psychiatric symptoms (i.e. anxiety). In the case of co-morbidity, patients present with greater difficulties and the problems tend to be more persistent. Together this stresses the importance of developing effective treatments. Psychological treatments can be effective but are rarely offered and thus alternative modes of treatment delivery should be considered such as internet interventions. Design: The study was a randomized controlled trial investigating treatment effects against an active control condition. Participants: 101 self-recruited participants, aged 65 to 88 years, were included. Intervention: The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Measurements: Depression, anxiety, life quality and cognitive decline were assessed through self-reported measures together with an online test of cognitive flexibility. Results: Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes. Cognitive decline improved during treatment and neither cognitive decline, nor cognitive flexibility predicted treatment outcome. Conclusion: The study adds to the evidence of internet-delivered psychological treatment for depression, with or without psychiatric comorbidities, in older adults. It also highlights the possibility of perceived cognitive decline as being part of the clinical picture and reversible, rather than reason for exclusion from for psychological treatment.
- Conditions
- Internet Treatment, Active Control
- Being tested
- Internet-delivered tailored cognitive behavior therapy
- Keywords
- depression, Internet-delivered cognitive-behavior therapy, Older adults
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered tailored cognitive behavior therapyBehavioural
Also called ICBT
Therapists-supported tailored 10-week treatment for depression in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Therapist-guided internet treatment. Receives: Behavioral: Internet-delivered tailored cognitive behavior therapy |
| Attention control | Active comparator | Non-directive supportive contact via email. Receives: Behavioral: Internet-delivered tailored cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale (GDS)
GDS scores range between 0 and 15, and five or less are considered within normal range
Measured: Change pre to 10-week post
Secondary outcomes (1)
Beck Depression Inventory II
For the 21 item BDI-II the maximum score is 63 points and scores below 14 are considered minimal depression.
Measured: Change pre to 10-week post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Feb 2016
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
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 Internet TreatmentStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269524
- Sponsor's protocol ID
- Alm study
- Acronym
- ALM
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request and in collaboration.
Publications
Nordgren LB, Ludvigsson M, Silfvernagel K, Tornhage L, Savas L, Soderqvist S, Dinnetz S, Henrichsen P, Larsson J, Strom H, Lindh M, Berger T, Andersson G. Tailored internet-delivered cognitive behavior therapy for depression in older adults: a randomized controlled trial. BMC Geriatr. 2024 Dec 10;24(1):998. doi: 10.1186/s12877-024-05597-8.
PubMed 39658784
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAILORED INTERNET-DELIVERED COGNTIVE BEHAVIOR THERAPY FOR DEPRESSED OLDER ADULTS: A RANDOMIZED TRIAL
- ClinicalTrials.gov ID
- NCT05269524
- Acronym / sponsor ID
- ALM / Alm study
- Conditions
- Internet Treatment, Active Control
- Keywords
- depression, Internet-delivered cognitive-behavior therapy, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Mar 2022 (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.
The study was a randomized controlled trial investigating treatment effects against an active control condition. 101 self-recruited participants, aged 65 to 88 years, were included. The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes.
Detailed description
Depression in older adults is associated with poorer functioning, worsened cognitive impairment and disability, as well as medical illnesses. It can also increase the risk of suicide and is associated with a high usage of medical services. It is common that depressive symptoms co-occur with other psychiatric symptoms (i.e. anxiety). In the case of co-morbidity, patients present with greater difficulties and the problems tend to be more persistent. Together this stresses the importance of developing effective treatments. Psychological treatments can be effective but are rarely offered and thus alternative modes of treatment delivery should be considered such as internet interventions. Design: The study was a randomized controlled trial investigating treatment effects against an active control condition. Participants: 101 self-recruited participants, aged 65 to 88 years, were included. Intervention: The intervention was a 10-week internet-based tailored CBT protocol consisting of 6-10 pre-defined modules tailored to patient profile and preferences. Measurements: Depression, anxiety, life quality and cognitive decline were assessed through self-reported measures together with an online test of cognitive flexibility. Results: Participants in the treatment group benefitted more than participants in the control condition on almost all measures with moderate between-group effect-sizes. Cognitive decline improved during treatment and neither cognitive decline, nor cognitive flexibility predicted treatment outcome. Conclusion: The study adds to the evidence of internet-delivered psychological treatment for depression, with or without psychiatric comorbidities, in older adults. It also highlights the possibility of perceived cognitive decline as being part of the clinical picture and reversible, rather than reason for exclusion from for psychological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Internet-delivered tailored cognitive behavior therapyTherapist-guided internet treatment. |
| Attention control | Active comparator | Behavioral: Internet-delivered tailored cognitive behavior therapyNon-directive supportive contact via email. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 65 years or older
- presence of depressive symptoms
- living in Sweden
- access to the internet and a computer on a regular basis.
Key exclusion criteria (5 listed)
- heightened suicidal ideation
- drug or alcohol abuse or dependency
- other ongoing psychological treatment
- severe psychiatric or cognitive problems
- unstable psychopharmacological medication
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 |
|---|---|---|
| Internet-delivered tailored cognitive behavior therapyAlso: ICBTTherapists-supported tailored 10-week treatment for depression in older adults. | Behavioural | Attention control, Treatment |
Primary outcome
Geriatric Depression Scale (GDS)
Time frame: Change pre to 10-week post
GDS scores range between 0 and 15, and five or less are considered within normal range
1 secondary outcome
Beck Depression Inventory II
Time frame: Change pre to 10-week post
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 8 Mar 2022.
- Derived from this study: PubMed 39658784Nordgren LB, Ludvigsson M, Silfvernagel K, Tornhage L, Savas L, Soderqvist S, Dinnetz S, Henrichsen P, Larsson J, Strom H, Lindh M, Berger T, Andersson G. Tailored internet-delivered cognitive behavior therapy for depression in older adults: a randomized controlled trial. BMC Geriatr. 2024 Dec 10;24(1):998. doi: 10.1186/s12877-024-05597-8.
- Individual participant dataSharing planned: Yes. On request and in collaboration.
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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 Internet-delivered tailored cognitive behavior therapy in people with Internet Treatment and Active Control, run by Linkoeping 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 5 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 8 Mar 2022. 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. 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?
Geriatric Depression Scale (GDS) (time frame: Change pre to 10-week post). 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 NCT05269524, 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 8 Mar 2022.