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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269524
Other study ID # Alm study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date June 30, 2018

Study information

Verified date February 2022
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date June 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - age 65 years or older - presence of depressive symptoms - living in Sweden - access to the internet and a computer on a regular basis. Exclusion Criteria: - heightened suicidal ideation - drug or alcohol abuse or dependency - other ongoing psychological treatment - severe psychiatric or cognitive problems - unstable psychopharmacological medication

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-delivered tailored cognitive behavior therapy
Therapists-supported tailored 10-week treatment for depression in older adults.

Locations

Country Name City State
Sweden Department of Behavioral Sciences and Learning, Linköping University Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geriatric Depression Scale (GDS) GDS scores range between 0 and 15, and five or less are considered within normal range Change pre to 10-week post
Secondary Beck Depression Inventory II For the 21 item BDI-II the maximum score is 63 points and scores below 14 are considered minimal depression. Change pre to 10-week post
See also
  Status Clinical Trial Phase
Completed NCT02782442 - Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) N/A