ICBT for Depression in Older Adults (ALM)

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.

Study Overview

• Status: Completed
• Conditions: Active Control; Internet Treatment
• Intervention / Treatment: Behavioral: Internet-delivered tailored cognitive behavior therapy

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Department of Behavioral Sciences and Learning, Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Therapist-guided internet treatment.	Behavioral: Internet-delivered tailored cognitive behavior therapy; Therapists-supported tailored 10-week treatment for depression in older adults.; Other Names: ICBT
Active Comparator: Attention control; Non-directive supportive contact via email.	Behavioral: Internet-delivered tailored cognitive behavior therapy; Therapists-supported tailored 10-week treatment for depression in older adults.; Other Names: ICBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: depression; Older adults; Internet-delivered cognitive-behavior therapy
• Other Study ID Numbers: Alm study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request and in collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No