HIV, Computerized Depression Therapy & Cognition

NCT03275571 | Terminated

• 1 other identifier: 2018-3508
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Among people with HIV, the severity of depressive symptoms has repeatedly been associated with the presence of self-reported cognitive difficulties, even in the absence of impairment on neuropsychological testing. There is uncertainty about the clinical importance of these self-reports, especially when neuropsychological testing is normal. However, there is growing evidence that these self-reports are clinically important. For example, among patients with major depressive disorder (MDD), evidence suggests that functional impairments is mediated by self-reported cognitive dysfunction, rather than objective cognitive dysfunction. Treatment of depression with Cognitive-Behaviour Therapy (CBT) has been shown to improve depressive symptoms and psychosocial functioning in patients with recurrent major depressive disorder, but there are few studies of the impact of psychotherapy on self-reported cognition and cognitive performance. Good Days Ahead (GDA) is a computerized treatment program developed to address symptoms of depression and anxiety. It teaches the basic principles of computerized behavioral therapy (CBT) in nine therapy sessions, each typically taking 30 minutes to complete. GDA has been found to be as effective as face-to-face CBT in decreasing symptoms of depression and anxiety. The hypothesis is that people whose depressive symptoms are reduced following treatment with cCBT will also report fewer cognitive difficulties than before treatment. A second hypothesis is that changes in self-reported cognition will be concordant with changes in cognitive performance, such that people who make no improvement in self-report cognition will also show no improvement in cognitive performance and those who do improve on self-report will improve on cognitive performance.

Conditions

HIV Infections; Depression; CBT

Keywords

Cognition; Intervention; Therapy

Outcome Measures

Primary Outcomes (1)

• Self-reported cognitive difficulties (C3Q)

  The Communicating Cognitive Concerns Questionnaire evaluated cognitive concerns participants may have.

  One week before the beginning of the intervention and up to 4 weeks after the end of the intervention

Secondary Outcomes (2)

• Depressive symptoms measure (HADS)

  One week before the beginning of the intervention and up to 4 weeks after the end of the intervention

• Cognitive Performance measure (B-CAM)

  Up to 9 months before the beginning of the intervention and up to 2 months after the end of the intervention.

Study Arms (1)

cCBT intervention

EXPERIMENTAL

Over the course of 9 weeks, 30 min online sessions, once per week, with a fictive therapist.

Behavioral: cCBT intervention

Interventions

cCBT intervention BEHAVIORAL

During each 30 minutes sessions, the participants will learn key concepts on depression, then will apply them to the program's main character who suffers from depression, and then will apply those techniques to their own personal challenges.

cCBT intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in the cohort study "Understanding and Optimizing Brain Health in HIV Now" with at least one remaining visit
• Able to communicate (understand and read) in English
• Depression subscale of the HADS (HADS-D) ≥ 8
• Presence of self-reported cognitive difficulties (PDQ) \>40
• Score on the B-CAM \> 14
• Willing to undergo 9 sessions of cCBT as per instructions and to have weekly contact with a research coordinator from the central site (by email or phone)
• Access to the internet

You may not qualify if:

• Current use of street drugs (excluding marijuana)

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

HIV Infections; Depression

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Marie-Josee Brouillette, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Lesley Fellows, MD/DPhil

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 7, 2017
• Study Start: September 6, 2017
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)