Efficacy of Online CBT for GAD Compared to Pharmaceutical Interventions

NCT04478526 | Completed

• 1 other identifier: PSIY-604-18
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Generalized anxiety disorder (GAD) is an extremely prevalent and debilitating mental health disorder. Currently, the gold standard treatment for GAD is cognitive behavioural therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs). While CBT is a gold standard treatment for GAD, it is costly, time-consuming, and often inaccessible. Fortunately, the electronic delivery of CBT (e-CBT) has emerged as a promising solution to address these barriers. e-CBT has shown to offer comparable results to in-person CBT while improving accessibility for patients and time efficiency for clinicians. The following project aims to investigate the treatment efficacy of e-CBT compared to, and in conjunction with pharmacotherapy for GAD. This study has been designed using a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to receive. Participants with a diagnosis of GAD will be enrolled in 1 of 3 possible treatment arms: e-CBT, medication, or combination. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared to the treatment efficacy of the medication arm and the combination arm. Conclusions: If e-CBT is shown to either be comparable to medication or that the effects of both treatments are augmented when used in tandem, these findings could have major implications on the mental health care system. e-CBT is a more accessible, and affordable treatment that could increase mental health care capacity by four-folds if proven viable.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Online Psychotherapy; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (4)

• Change in State Trait Anxiety Level

  State Trait Anxiety Inventory (STAI) - Scale: 1-4 (1 = not at all, 4 = very much)

  Baseline, week 2, 4, 6, 8, 10, 12, plus 6-month follow-up

• Change in Quality of Life

  Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-QSF) - Scale: 1-5 (1 = very poor, 5 = very good)

  Baseline, week 2, 4, 6, 8, 10, 12, plus 6-month follow-up

• Change in Generalized Anxiety Levels

  Generalized Anxiety Disorder - 7 (GAD-7) - Scale: 0-3 (0 = never, 3 = nearly every day)

  Baseline, week 2, 4, 6, 8, 10, 12, plus 6-month follow-up

• Change in Depression and Anxiety Scale

  42-item Depression Anxiety Stress Scales (DASS-42) Scale: 0-3 (0 = not at all, 3 = very much)

  Baseline, week 2, 4, 6, 8, 10, 12, plus 6-month follow-up

Secondary Outcomes (1)

• Demographics Information

  Baseline, week 2, 4, 6, 8, 10, 12, plus 6-month follow-up

Study Arms (3)

e-CBT

EXPERIMENTAL

Weekly sessions of e-CBT through OPTT will consist of approximately 30 slides. Each session is expected to last approximately 50 minutes. The content and format of each weekly online session were designed to mirror live CBT. The slides will highlight a different topic each week and include general information, an overview of skills and homework on that topic. The homework included in each session will be submitted through OPTT and reviewed by the clinicians with personalized feedback provided by clinicians within three days of submission. Weekly homework submission for feedback will be mandatory before being eligible for the next session. Biweekly GAD-7, DASS-42 and Q-LES-SF questionnaires will be completed through OPTT. A second STAI will be completed in the final week of e-CBT treatment.

Behavioral: Electronic Cognitive Behavioural Therapy

Pharmacotherapy

EXPERIMENTAL

Biweekly meeting with psychiatrist with GAD-7, DASS-42 and Q-LES-SF. Pharmacotherapy class decided according to protocol developed in accordance with Canada's best practice guidelines for GAD treatment. At second appointment, medication will be maintained and optimized, regardless of response. At third appointment, optimized if partial response or switched according to protocol if no response. Partial response is improvement of 20% or more in GAD-7. If switched, 6-week protocol will recommence with new medication. At fourth appointment, dosage optimized if responding well to medication and improvement greater than 50% within primary arm, or 20% if secondary arm, patient will remain on said medication for remainder of 12-week study. If not improving more than 20%, medication switched according to protocol and 6-week protocol will recommence. If primary arm and 20-50% improvement after six weeks on new medication, augmented with olanzapine, risperidone or benzodiazepines.

Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

e-CBT + Pharmacotherapy

EXPERIMENTAL

Participants will commence both treatments described above simultaneously.

Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors); Behavioral: Electronic Cognitive Behavioural Therapy

Interventions

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) DRUG

If never taken SSRI or SNRI, commence primary medication arm (SSRI: sertraline, escitalopram or Pregabalin/SNRI: duloxetine, venlafaxine) will be described to patient and will begin either. If deemed unresponsive to either prior to study, commence medication they have not been previously unresponsive to. Unresponsive if GAD did not improve after treatment with maximum tolerated dose for 8-weeks. If deemed unresponsive to SSRI and SNRI/pregabalin, commence secondary medication arm (bupropion/mirtazepine, buspirone/imipramine) with both being described to patient and begin either. Switch protocol: If unresponsive after 4 or 6 weeks, switch to another class. If started in primary or secondary and not previously demonstrated non-response to second class of medications within arm, switch to second class within arm. If started in primary and previously deemed unresponsive to second class, begin secondary if non-response indicates switch necessary.

Pharmacotherapy; e-CBT + Pharmacotherapy

Electronic Cognitive Behavioural Therapy BEHAVIORAL

Weekly sessions of e-CBT through OPTT will consist of approximately 30 slides. Each session is expected to last approximately 50 minutes. The content and format of each weekly online session was designed to mirror live CBT. The slides will highlight a different topic each week and include general information, an overview of skills and homework on that topic. The homework included in each session will be submitted through OPTT and reviewed by the clinicians with personalized feedback provided by clinicians within three days of submission. Weekly homework submission for feedback will be mandatory before being eligible for the next session. Biweekly GAD-7, DASS-42 and Q-LES-SF questionnaires will be completed through OPTT. A second STAI will be completed in the final week of e-CBT treatment.

e-CBT; e-CBT + Pharmacotherapy

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Have consistent and reliable access to the internet
• Be diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) by a clinician
• Meet the criteria for GAD according to the GAD-7 Screener (GAD-7)
• Be competent to consent to participate
• Speak and read English

You may not qualify if:

• \- Patients will be deemed ineligible for participation in the study if they are in acute distress.

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (1)

• Alavi N, Stephenson C, Yang M, Shirazi A, Shao Y, Kumar A, Yee CS, Miller S, Stefatos A, Gholamzadehmir M, Abbaspour Z, Patel A, Patel C, Reshetukha T, Omrani M, Groll D. Determining the Efficacy of Electronic Cognitive Behavioral Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2021 May 27;10(5):e27772. doi: 10.2196/27772.

  PMID: 33857917 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Serotonin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Nazanin Alavi

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: This study has been designed using a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to participate in. This research design aims to be naturalistic by mimicking the decisions made by patients and physicians regarding the course of treatment and type of pharmacotherapy prescribed within mental health services across Ontario. The treatments provided within the study also aim to replicate evidence-based best practice clinical guidelines for the treatment of GAD. Arms include eCBT, eCBT + Pharmacotherapy, Pharmacotherapy.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: April 29, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)