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

NCT04508868 | Terminated

• 1 other identifier: 2020-02079
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Depressive Symptoms

Keywords

Depression; Depressive Symptoms; Cognitive Behavioral Therapy; Social Isolation; Coronavirus; Pandemic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S

  MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54.

  Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Secondary Outcomes (8)

• Change from baseline in depressive symptoms using the Geriatric Depression Rating Scale 15, GDS-15

  Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

• Change from baseline in depressive symptoms using the Patient Health Questionnaire 9, PHQ-9

  Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

• Change in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI

  Baseline; Intervention Week 4.

• Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item, GAD-7

  Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

• Change from baseline in behavioral activation using The Behavioral Activation for Depression Scale - Short Form, BADS-SF

  Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Study Arms (2)

Brief Behavioral Activation with Mental Imagery

EXPERIMENTAL

Four weekly sessions of Brief Behavioral Activation with Mental Imagery.

Behavioral: Brief Behavioral Activation with Mental Imagery

Minimal Attention Control Intervention

PLACEBO COMPARATOR

Four weeks with weekly follow-up calls.

Behavioral: Minimal Attention Control Intervention

Interventions

Brief Behavioral Activation with Mental Imagery BEHAVIORAL

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.

Brief Behavioral Activation with Mental Imagery

Minimal Attention Control Intervention BEHAVIORAL

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

Minimal Attention Control Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Residing in the County of Västmanland
• Access to telephone
• Fluent in written and spoken Swedish
• Reporting clinically significant depressive symptoms above cut-of on depression measures and/or by structured clinical interview

You may not qualify if:

• Severe depression
• Elevated risk of suicide
• Current substance use disorder
• Current or previous manic/hypomanic episodes
• Current psychotic disorder
• Current diagnosis of dementia/major neurocognitive disorder
• Currently receiving psychological therapy

Sponsors & Collaborators

• Uppsala University: lead
• Västmanland County Council, Sweden: collaborator

Study Sites (1)

Adult Psychiatric Clinic

Västerås, Västmanland County, 72189, Sweden

Location

MeSH Terms

Conditions

Depression; Social Isolation; Coronavirus Infections

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Mattias Damberg, MD, PhD

  County of Vastmanland and Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 11, 2020
• Study Start: August 31, 2020
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: * Study protocol to be shared before data collection is completed * Statistical Analysis Plan to be shared before data analysis begin
• Access Criteria: Data will be shared upon reasonable requests assessed by the investigators.

Locations

SE (1)