Treatment of Depressive Symptoms in Older Individuals in Isolation During Covid-19

NCT04508868 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-12-31

No results posted yet for this study

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. 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.

Conditions

Interventions

BEHAVIORAL

Brief Behavioral Activation with Mental Imagery

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.

BEHAVIORAL

Minimal Attention Control Intervention

Weekly call with follow-up of psychiatric symptoms and assessment of suicide risk.

Sponsors & Collaborators

  • Västmanland County Council, Sweden

    collaborator OTHER_GOV
  • Uppsala University

    lead OTHER

Principal Investigators

  • Mattias Damberg, MD, PhD · County of Vastmanland and Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2020-12-23
Completion
2020-12-23

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508868 on ClinicalTrials.gov