Major Depressive DisorderNCT05134103
Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
A study testing Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression in people with Major Depressive Disorder, run by Ontario Shores Centre for Mental Health Sciences.
Trial summary
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years
- Meets Diagnostic Assessment Research Tool (DART) screening criteria for a primary diagnosis of depression and reports being at least moderately depressed according to the PHQ-9
- Sufficient language proficiency to understand the treatment materials written at grade 10 reading level
- Understands what TAiCBT and is open and interested to participating in a study using this treatment modality
- Is able to reliably access the internet, and has basic computer skills to navigate the internet using a web browser
- Willing to participate in a waitlist-control study and be followed for 12 months
Who cannot join
- Suicidal intent or clinically significant suicidal ideation
- Clinically significant self-harm
- Active psychotic illness
- Currently participating in psychological treatment for depression and/or receiving evidence-based treatment (other than medication) for depression
- Clinically significant alcohol and/or other substance use including prescription and over the counter medication that would likely interfere with treatment
- Current or previous diagnosis of Borderline Personality Disorder
- Does not meet DART criteria for a primary diagnosis of depression
- Change in psychotropic medication within 3 weeks of treatment baseline
About this study
Official title: A 12-week Randomized Waitlist-Controlled Trial of Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.
The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.
Read more
Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.
It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.
- Conditions
- Major Depressive Disorder
- Being tested
- Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression, Waitlist Control Group
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for DepressionBehavioural
Also called Internet-CBT
The treatment consists of 11 depression modules delivered approximately once per week (at therapists' discretion) over a period of 12 weeks. Additionally, the therapist typically tailors treatment to client's individual needs by including supplementary modules for a variety of issues such as generalized anxiety, panic, social anxiety, post-traumatic stress, insomnia, pain, and relationships etc. Clients can complete the readings, exercises, and worksheets at any convenient time, using their web-enabled smartphone, tablet, or computer. Access to the modules and all messaging is provided through the secure platform. Messaging is "asynchronous" meaning participants can message their therapist as often as they choose and expect a response within 1-2 business days. After 12 weeks of active treatment, they will have unguided access (without therapist support) to the treatment materials that were covered for an additional 40 weeks.
Waitlist Control GroupOther
Participants assigned to this arm will wait for 12 weeks before receiving active treatment condition
| Study group | Role | What they receive |
|---|---|---|
| Mindbeacon TAI-CBT for Depression group | Experimental | Participants randomized to this condition will receive immediate Therapist-Guided Internet-CBT for Depression for 12 weeks. Receives: Behavioral: Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression |
| Waitlist Control Group | Other | Participants randomized to this condition will remain on the waitlist for 12 weeks before crossing over and receiving Therapist-Guided Internet-CBT for Depression for 12 weeks. Receives: Other: Waitlist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
IAPT Definition of "Recovery" (Change between Baseline and Post-treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
IAPT Definition of "Recovery" (Change between baseline and 3 month follow-up)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
IAPT Definition of "Recovery" (Change between baseline and 12 month follow-up)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
IAPT Definition of "Reliable improvement" (Change between Baseline and Post-treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
IAPT Definition of "Reliable improvement" (Change between baseline, and 3 month follow-up)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
IAPT Definition of "Reliable improvement" (Change between baseline and 12 month follow-up)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
IAPT definition of "Reliable recovery" (Change between Baseline and Post-treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and post-treatment (week 12 of treatment)
IAPT definition of "Reliable recovery" (Change between baseline and 3 month follow-up)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
IAPT definition of "Reliable recovery" (Change between baseline and 12 month follow-up)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
Measured: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Secondary outcomes (9)
Work and Social Adjustment Scale (WSAS) - (Change between Baseline and Post-treatment)
This is a simple, reliable and valid measure of impaired functioning. It is a 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships. This scale ranges from 0-40 with 40 indicating a severe level of functional impairment.
Measured: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Work and Social Adjustment Scale (WSAS) - (Change between baseline and 3 month follow-up)
This is a simple, reliable and valid measure of impaired functioning. It is a 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships. This scale ranges from 0-40 with 40 indicating a severe level of functional impairment.
Measured: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Work and Social Adjustment Scale (WSAS) - (Change between baseline and 12 month follow-up)
This is a simple, reliable and valid measure of impaired functioning. It is a 5-item self-report measure that provides an experiential impact of a disorder from the patient's point of view. It looks at how the disorder impairs the patient's ability to function day to day on five dimensions: work, social life, home life, private life and close relationships. This scale ranges from 0-40 with 40 indicating a severe level of functional impairment.
Measured: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and post-treatment)
Items on the PHQ-9 reflect symptoms of Major Depressive Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-27 with higher scores indicating more severe depression.
Measured: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 3 month follow-up)
Items on the PHQ-9 reflect symptoms of Major Depressive Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-27 with higher scores indicating more severe depression.
Measured: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 12 month follow-up)
Items on the PHQ-9 reflect symptoms of Major Depressive Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-27 with higher scores indicating more severe depression.
Measured: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and post-treatment)
Items on the GAD-7 reflect symptoms of Generalized Anxiety Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-21 with higher scores indicating more severe anxiety.
Measured: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 3 month follow-up)
Items on the GAD-7 reflect symptoms of Generalized Anxiety Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-21 with higher scores indicating more severe anxiety.
Measured: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 12 month follow-up)
Items on the GAD-7 reflect symptoms of Generalized Anxiety Disorder, and provides a dimensional measure of symptom severity, self-administered by participants. Scores on this scale range from 0-21 with higher scores indicating more severe anxiety.
Measured: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Why it stopped: Sponsor pulled out of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a waitlist-controlled, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Shores Centre for Mental Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mindbeacon
- Responsible party
- Sponsor
- Investigators
- Phil Klassen, MD, Principal investigator, Ontario Shores Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134103
- Sponsor's protocol ID
- 21-004-B
- Status last verified
- Apr 2023
- First submitted
- 5 Oct 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers. Anonymized/deidentified aggregate data for the study may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized Waitlist-Controlled Trial of Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
- ClinicalTrials.gov ID
- NCT05134103
- Acronym / sponsor ID
- 21-004-B
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor pulled out of study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ontario Shores Centre for Mental Health SciencesUniversity, hospital or other
- Collaborators
- Mindbeacon
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.
The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.
Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.
It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a waitlist-controlled, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mindbeacon TAI-CBT for Depression group | Experimental | Behavioral: Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for DepressionParticipants randomized to this condition will receive immediate Therapist-Guided Internet-CBT for Depression for 12 weeks. |
| Waitlist Control Group | Other | Other: Waitlist Control GroupParticipants randomized to this condition will remain on the waitlist for 12 weeks before crossing over and receiving Therapist-Guided Internet-CBT for Depression for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age of 18 years
- Meets Diagnostic Assessment Research Tool (DART) screening criteria for a primary diagnosis of depression and reports being at least moderately depressed according to the PHQ-9
- Sufficient language proficiency to understand the treatment materials written at grade 10 reading level
- Understands what TAiCBT and is open and interested to participating in a study using this treatment modality
- Is able to reliably access the internet, and has basic computer skills to navigate the internet using a web browser
Key exclusion criteria (8 listed)
- Suicidal intent or clinically significant suicidal ideation
- Clinically significant self-harm
- Active psychotic illness
- Currently participating in psychological treatment for depression and/or receiving evidence-based treatment (other than medication) for depression
- Clinically significant alcohol and/or other substance use including prescription and over the counter medication that would likely interfere with treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for DepressionAlso: Internet-CBTThe treatment consists of 11 depression modules delivered approximately once per week (at therapists' discretion) over a period of 12 weeks. Additionally, the therapist typically tailors treatment to client's individual needs by including supplementary modules for a variety of issues such as generalized anxiety, panic, social anxiety, post-traumatic stress, insomnia, pain, and relationships etc. Clients can complete the readings, exercises, and worksheets at any convenient time, using their web-enabled smartphone, tablet, or computer. Access to the modules and all messaging is provided through the secure platform. Messaging is "asynchronous" meaning participants can message their therapist as often as they choose and expect a response within 1-2 business days. After 12 weeks of active treatment, they will have unguided access (without therapist support) to the treatment materials that were covered for an additional 40 weeks. | Behavioural | Mindbeacon TAI-CBT for Depression group |
| Waitlist Control GroupParticipants assigned to this arm will wait for 12 weeks before receiving active treatment condition | Other | Waitlist Control Group |
Primary outcome
IAPT Definition of "Recovery" (Change between Baseline and Post-treatment)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT Definition of "Recovery" (Change between baseline and 3 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT Definition of "Recovery" (Change between baseline and 12 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
The IAPT criteria for 'Recovery' are met when patients move from 'caseness' at the beginning of the intervention (e.g., scoring >9 on the PHQ-9 or >7 on the GAD-7) to 'non-caseness' at the end of treatment (thus scoring below the cut-off)
IAPT Definition of "Reliable improvement" (Change between Baseline and Post-treatment)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT Definition of "Reliable improvement" (Change between baseline, and 3 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT Definition of "Reliable improvement" (Change between baseline and 12 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Reliable improvement is defined as when the patient has a 'reliable' decrease in their PHQ-9 / GAD-7 (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) score upon completion of their course of treatment
IAPT definition of "Reliable recovery" (Change between Baseline and Post-treatment)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
IAPT definition of "Reliable recovery" (Change between baseline and 3 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
IAPT definition of "Reliable recovery" (Change between baseline and 12 month follow-up)
Time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Reliable recovery is defined as when the patient meets the criteria for both recovery and reliable improvement as defined above. Thus, a patient who moves from caseness to non-caseness, and also shows a 'reliable' (reduction in PHQ-9 score of 6 or more, and reduction in GAD-7 score of 4 or more) decrease in their symptom scores, is said to have a reliable recovery
9 secondary outcomes
Work and Social Adjustment Scale (WSAS) - (Change between Baseline and Post-treatment)
Time frame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Work and Social Adjustment Scale (WSAS) - (Change between baseline and 3 month follow-up)
Time frame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Work and Social Adjustment Scale (WSAS) - (Change between baseline and 12 month follow-up)
Time frame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and post-treatment)
Time frame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 3 month follow-up)
Time frame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 12 month follow-up)
Time frame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and post-treatment)
Time frame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 3 month follow-up)
Time frame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 12 month follow-up)
Time frame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers. Anonymized/deidentified aggregate data for the study may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Klassen, MD principal investigator
Ontario Shores Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression in people with Major Depressive Disorder, run by Ontario Shores Centre for Mental Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IAPT Definition of "Recovery" (Change between Baseline and Post-treatment) (time frame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.