NCT05447091

Brief Summary

Sustained negative mood and depression are characterized by functional impairment, and significant reduction in quality of life. Cognitive models of depression emphasize the role of impaired cognitive control - the mental abilities determining goal directed behaviors - in contributing to depressive symptoms. Indeed, research findings from subclinical and clinical populations show that depressive symptoms are associated with decreased cognitive control abilities. The THRIVE trial is a double-blind, proof-of-concept randomized controlled trial (RCT). The aims of the study are to investigate the feasibility and efficacy of an innovative, custom-made tablet video game, Legends of Hoa'manu (LOH), which is designed to enhance cognitive control, in alleviating mood and improving cognitive control in adults. Participants with mild to major depressive symptoms will be randomized to receive either LoH or a control intervention. Cognitive control, mood and depressive symptoms will be assessed at baseline, post training, after at a 3-week and a 3-month follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

July 3, 2022

Last Update Submit

September 20, 2023

Conditions

Mood DisturbanceDepressive Symptoms

Keywords

Cognitove ControlVideo-gamesCognitive Control Training

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory (BDI-II)

    To assess levels and change of depressive symptoms. The BDI-II consists of 21-items, scored on a Likert scale from 0 to 3 (range 0-63), and has demonstrated high reliability and good concurrent, content, and structural validity for screening depression in outpatient and student samples.

    3 weeks

Secondary Outcomes (4)

  • Ruminative Responses Scale-Short Version (RRS-10)

    3 weeks

  • Generalised Anxiety Disorder-7 (GAD7)

    3 weeks

  • Adaptive Cognitive Evaluation (ACE)

    3 weeks

  • WHO-5 Well-Being Index (WHO-5)

    3 weeks

Other Outcomes (1)

  • Satisfaction with the intervention questionnaire

    3 weeks

Study Arms (3)

Active high dose treatment

ACTIVE COMPARATOR

Active LOH game training- high dose

Behavioral: LOH game- high dose

Active low dose treatment

ACTIVE COMPARATOR

Acrive LOH game training - low dose

Behavioral: LOH game- low dose

Sham treatment

SHAM COMPARATOR

Sham LOH game- high dose

Behavioral: LOH sham game

Interventions

LOH game- high doseBEHAVIORAL

Participants will be asked to complete 15 half-hour training sessions, over 3 weeks, ie about 5 training sessions a week, and a total of 7.5 hours of training for 3 weeks.

Active high dose treatment
LOH game- low doseBEHAVIORAL

Participants will be asked to complete 6 half-hour training sessions, over 3 weeks, ie about 2 training sessions a week, and a total of 3 hours of training for 3 weeks.

Active low dose treatment
LOH sham gameBEHAVIORAL

Participants will be asked to complete 15 half-hour training sessions, over three weeks, using sham version of the game. the sham version does not include components of cognitive training.

Sham treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and woman 18-60 years of age.
  • Symptoms at a minimal level and above of depression, according to a score of 5 or higher in the Personal Health Questionnaire Depression Scale (PHQ-8).
  • Able and interested in signing an informed consent form.
  • speak and read Hebrew, English or Russian.

You may not qualify if:

  • Video game addiction disorder.
  • Neurological diseases that cause cognitive decline (such as dementia), based on self-report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Computerized Neurotherapy Lab, School of OT, Hebrew University, Mt. Scopus Campus

Jerusalem, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Mor Nahum, PhD

    Hebrew University of Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are not aware of the treatment group they are assigned to. The PI is not aware of the treatment condition in which participants are. Finally, the assessors are blinded to the group assignment as well.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

June 12, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)