NCT05269524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

February 25, 2022

Last Update Submit

February 25, 2022

Conditions

Keywords

depressionInternet-delivered cognitive-behavior therapyOlder adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Beck Depression Inventory II

    Change pre to 10-week post

Study Arms (2)

Treatment

EXPERIMENTAL

Therapist-guided internet treatment.

Behavioral: Internet-delivered tailored cognitive behavior therapy

Attention control

ACTIVE COMPARATOR

Non-directive supportive contact via email.

Behavioral: Internet-delivered tailored cognitive behavior therapy

Interventions

Therapists-supported tailored 10-week treatment for depression in older adults.

Also known as: ICBT
Attention controlTreatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 years or older
  • presence of depressive symptoms
  • living in Sweden
  • access to the internet and a computer on a regular basis.

You may not qualify if:

  • heightened suicidal ideation
  • drug or alcohol abuse or dependency
  • other ongoing psychological treatment
  • severe psychiatric or cognitive problems
  • unstable psychopharmacological medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 8, 2022

Study Start

February 1, 2016

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

On request and in collaboration.

Locations