NCT03445598

Brief Summary

This study is designed to evaluate a novel online tool to deliver computerized Cognitive Behavioral Therapy (CBT). Participants will be randomized into three groups: experimental, active control, and waitlist. Participants in the experimental group will have access to the full-featured online tool designed to deliver CBT in an interactive and personalized manner. The participants in the active control group will have access to a limited version of the online tool designed to deliver basic CBT in plain text format. The waitlisted participants will be put on a waitlist for 6 weeks. We hypothesize that the experimental group participants will show a significantly higher reduction in depression symptom severity and will show increased engagement and adherence to the online tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

February 14, 2018

Last Update Submit

June 30, 2019

Conditions

Depressive Symptoms

Keywords

depressionanxietyCBTpsychotherapye-healthCCBT

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Health Questionnaire-9 score

    Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

    change from baseline to program completion or last usage (upto 90 days).

Secondary Outcomes (3)

  • Change in Generalized Anxiety Disorder 7 score

    baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

  • Time spent with the program

    from beginning till last usage (upto 180 days)

  • Follow-up Patient Health Questionnaire-9 score

    90 days after program completion

Other Outcomes (5)

  • Change in Patient Health Questionnaire-9 score (Intermediate reports)

    after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)

  • Change in Generalized Anxiety Disorder 7 score (Intermediate reports)

    after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)

  • User experience survey

    after module 3 (average 3 weeks) and module 6 (upto 90 days) of program

  • +2 more other outcomes

Study Arms (3)

Interactive CCBT group

EXPERIMENTAL

This group receives Interactive and Personalized CCBT

Behavioral: Interactive and personalized CCBT

Limited CCBT control group

ACTIVE COMPARATOR

This group receives Feature-limited CCBT

Behavioral: Feature-limited CCBT

Waitlist control group

OTHER

This group receives waitlist control

Other: Waitlist control

Interventions

Interactive and personalized CCBTBEHAVIORAL

Participants will go through an automated program. Participants will learn and practice the techniques of CBT through multimedia elements along with personalized content and interactive features in the program

Interactive CCBT group
Feature-limited CCBTBEHAVIORAL

Participants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features.

Limited CCBT control group
Waitlist controlOTHER

Participants will be put on a waitlist for a period of 6 weeks.

Waitlist control group

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Fluent in English
  • PHQ-9 Score from 5 to 19
  • Access to internet-connected computer or tablet device
  • Country: India

You may not qualify if:

  • Suicide ideation (score greater than 0 on the 9th question of PHQ-9)
  • Unemployed
  • Current or previous diagnosis of bipolar disorder/manic-depressive disorder or psychosis
  • Prospective participants who say they only want to check out the program and do not plan to complete it are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Institute of Technology Kanpur

Kanpur, Uttar Pradesh, 208016, India

Location

Related Publications (3)

  • Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G; REEACT collaborative. Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362-367. doi: 10.1192/bjp.bp.116.192435. Epub 2017 Mar 2.

    PMID: 28254959BACKGROUND

  • Gilbody S, Littlewood E, Hewitt C, Brierley G, Tharmanathan P, Araya R, Barkham M, Bower P, Cooper C, Gask L, Kessler D, Lester H, Lovell K, Parry G, Richards DA, Andersen P, Brabyn S, Knowles S, Shepherd C, Tallon D, White D; REEACT Team. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015 Nov 11;351:h5627. doi: 10.1136/bmj.h5627.

    PMID: 26559241BACKGROUND

  • Ghosh A, Cherian RJ, Wagle S, Sharma P, Kannan KR, Bajpai A, Gupta N. An Unguided, Computerized Cognitive Behavioral Therapy Intervention (TreadWill) in a Lower Middle-Income Country: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2023 Apr 26;25:e41005. doi: 10.2196/41005.

    PMID: 37099376DERIVED

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Nitin Gupta, PhD

    Indian Institute of Technology Kanpur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant is masked to the intervention assigned to them. All outcome measures are self-reported by the participants through a computer program without any involvement of the experimenters.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 26, 2018

Study Start

February 14, 2018

Primary Completion

March 2, 2019

Study Completion

May 31, 2019

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

IN(1)