Treatment Resistant Depression (TRD)NCT06729580
Risk-Targeted Behavioural Activation for the Management of Treatment-Resistant Depression.
A study testing Behavioural Activation in people with Treatment Resistant Depression (TRD), run by McGill University at 1 site in Canada.
Trial summary
Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Behavioural Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2022to 30 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of Major Depressive Disorder
- The date of diagnosis of MDD preceded referral by at least 12 months
- At least one previous prescription of an antidepressant failed to yield therapeutic response
- Currently taking an antidepressant
- A PHQ9 score in the moderate to severe range of depression at the time of enrolment
Who cannot join
- Participating in another psychotherapeutic intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk-Targeted Behavioral Activation: a Novel Approach to the Management of Treatment-Resistant Depression.
Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. This study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.
Read the detailed description
Objective: The purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (RTBA) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (TRD). Methods: The study sample consisted of 118 individuals with TRD, who were currently absent from work and referred to an occupational rehabilitation service. The RTBA intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. The objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. Measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Behavioural Activation
- Keywords
- treatment resistant depression, catastrophic thinking, perceived injustice, behavioural activation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural ActivationBehavioural
10-week standardized behavioural activation program.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural Activation for Depression. | Experimental | All participants were enrolled in a 10-week standardized risk-targeted behavioural activation intervention. Receives: Behavioral: Behavioural Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptom severity.
The Patient Health Questionnaire (PHQ9) was used to assess depressive symptom severity. PHQ-9 scores can range from 0 to 27 with higher scores indicating more severe depressive symptoms.
Measured: baseline/immediately after the intervention
Secondary outcomes (2)
Catastrophic thinking
The Symptom Catastrophizing Scale (SCS) was used to assess catastrophic appraisals of depressive symptoms. Scores on the SCS range from 0 to 14 where higher scores reflect a higher degree of catastrophic thinking.
Measured: baseline/immediately after the intervention.
Perceived Injustice
The Injustice Experience Questionnaire - Short Form (IEQ-SF) was used to assess injustice appraisals. Scores on the IEQ-SF range from 0 to 10 where higher scores reflect a greater sense of injustice.
Measured: baseline/immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start5 Jan 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Depression (TRD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sullivan, McGill University
- Investigators
- Michael Sullivan, PhD, Principal investigator, McGill UniversityHeather Adams, BSW, Study director, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729580
- Sponsor's protocol ID
- CRC245719
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Targeted Behavioral Activation: a Novel Approach to the Management of Treatment-Resistant Depression.
- ClinicalTrials.gov ID
- NCT06729580
- Acronym / sponsor ID
- CRC245719
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- treatment resistant depression, catastrophic thinking, perceived injustice, behavioural activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 11 Dec 2024 (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.
Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. This study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.
Detailed description
Objective: The purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (RTBA) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (TRD). Methods: The study sample consisted of 118 individuals with TRD, who were currently absent from work and referred to an occupational rehabilitation service. The RTBA intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. The objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. Measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioural Activation for Depression. | Experimental | Behavioral: Behavioural ActivationAll participants were enrolled in a 10-week standardized risk-targeted behavioural activation intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of Major Depressive Disorder
- The date of diagnosis of MDD preceded referral by at least 12 months
- At least one previous prescription of an antidepressant failed to yield therapeutic response
- Currently taking an antidepressant
- A PHQ9 score in the moderate to severe range of depression at the time of enrolment
Key exclusion criteria (1 listed)
- Participating in another psychotherapeutic intervention.
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 |
|---|---|---|
| Behavioural Activation10-week standardized behavioural activation program. | Behavioural | Behavioural Activation for Depression. |
Primary outcome
Depression symptom severity.
Time frame: baseline/immediately after the intervention
The Patient Health Questionnaire (PHQ9) was used to assess depressive symptom severity. PHQ-9 scores can range from 0 to 27 with higher scores indicating more severe depressive symptoms.
2 secondary outcomes
Catastrophic thinking
Time frame: baseline/immediately after the intervention.
Perceived Injustice
Time frame: baseline/immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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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.
Michael Sullivan, PhD principal investigator
McGill University
Heather Adams, BSW study director
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation in people with Treatment Resistant Depression (TRD), run by McGill University at 1 site in Canada.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression symptom severity. (time frame: baseline/immediately after the intervention). 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 11 Dec 2024.