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Depression, PostpartumNCT04012580

Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression

A study testing Therapist-assisted ICBT in people with Depression, Postpartum and Anxiety, run by University of Regina at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the proposed study, the investigators will examine the efficacy of transdiagnostic, Internet-delivered cognitive behaviour therapy (ICBT) in the treatment of postpartum anxiety and depression. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Postpartum, Anxiety
What is being tested?
Therapist-assisted ICBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
30 Sep 2019to 27 Nov 2020
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • female
  • have given birth and have a child under one year of age
  • score of 10 or above on EPDS or a score of 9 or above on the GAD-7
  • be a resident of Saskatchewan
  • have access to a secure computer and the Internet, and be comfortable using technology
  • be available to work through treatment each week
  • be willing to provide a medical contact as an emergency contact

Who cannot join

  • younger than 18 years
  • not female
  • have not given birth to a child less than one year of age
  • are experiencing minimal to no symptoms of anxiety and/or depression
  • are not a resident of Saskatchewan
  • have been hospitalized within the last year for mental health and/or suicide risk concerns;
Show all 11Show fewer
  • have unmanaged problems with alcohol, drugs, psychosis or mania, or are at increased suicide risk (specific plans and intent reflected by the Suicide Behaviors Questionnaire-Revised)
  • started a new psychotropic medication within the past month
  • do not have access to a secure computer and the Internet or is not comfortable using technology
  • are not available to work through treatment each week
  • are not willing to provide a medical contact as an emergency contact

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Online Therapy Unit, University of Regina

    Regina, Saskatchewan, S4S 0A2

Other trials in Canada

About this study

Official title: Examining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial

In the proposed study, the investigators will examine the efficacy of transdiagnostic, Internet-delivered cognitive behaviour therapy (ICBT) in the treatment of postpartum anxiety and depression. Half of participants will receive the treatment immediately, and half of the participants will be assigned to a treatment-as-usual control condition. Participants assigned to the control condition will be offered the treatment after a 12-week waiting period, although data from this portion will not be included in the current study. All participants will complete questionnaires prior to the start of the treatment, following treatment (or corresponding 8-week waiting period), at 1-months follow-up (or corresponding 12-week waiting period), and at 6-months follow-up (in those assigned to the treatment condition). Further, those who receive the treatment will complete questionnaires on a weekly basis. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, participants will be asked to rate the program content, the overall service, and their satisfaction with the program.

Being tested
Therapist-assisted ICBT
Keywords
postpartum, depression, anxiety, internet-delivered cognitive behaviour therapy, randomized controlled trial, therapist-assistance
Medical subject headings
Depression, Postpartum, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapist-assisted ICBTBehavioural

    An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students will provide support by email once a week.

Study groups in NCT04012580
Study groupRoleWhat they receive
Therapist-assisted ICBTExperimentalAn 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. In addition to the program, participants will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact provided on a weekly basis.
Receives: Behavioral: Therapist-assisted ICBT
Treatment as usual controlNo interventionParticipants will not receive access to the transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) program for 12-weeks. Participants will be permitted to access community resources (e.g., support groups). After 12-weeks, participants will be offered the program although their treatment data will not be included in the current study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postpartum depression

    Measured by the Edinburgh Postnatal Depression Scale (EPDS). 10 items are summed into a total score ranging from 0 to 30, with higher scores indicating more severe depression.

    Measured: Baseline, weeks 1-9, 13, and 37

  2. Change in anxiety

    Measured by the Generalized Anxiety Disorder Scale 7-Item (GAD-7). 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

    Measured: Baseline, weeks 1-9, 13, and 37

Secondary outcomes (9)

  1. Change in depression

    Measured by the Patient Health Questionnaire 9-Item (PHQ-9). 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

    Measured: Baseline, weeks 1-9, 13, and 37

  2. Change in depression, anxiety, stress

    Measured by the Depression and Anxiety Stress Scales (DASS-21). 21 items are summed into a total score ranging from 0 to 42, with higher scores indicating more severe symptoms with respect to the depression, anxiety, and stress subscales.

    Measured: Baseline, 8 weeks, 1 month, and 6 months

  3. Mother-infant bonding

    Measured by the Postnatal Bonding Questionnaire (PBQ). 25 items are summed into a total score ranging from 0 to 125, with higher scores indicating more reported difficulties bonding with one's baby.

    Measured: Baseline, weeks 9, 13, and 37

  4. Relationship satisfaction

    Measured by the Dyadic Adjustment Scale-7 item (DAS-7). 7 items are summed into a total score ranging from 0 to 32, with higher scores indicating greater perceived relationship quality.

    Measured: Baseline, weeks 9, 13, and 37

  5. Treatment credibility

    Measured by the Credibility/Expectancy Questionnaire (CEQ). 6 items are summed into a total score and two subscales (credibility and expectancy). Total scores can range from 3 to 27, with higher scores representing greater perceptions of ICBT credibility.

    Measured: Baseline and week 9

  6. Therapeutic alliance

    Measured by the Working Alliance Inventory-Short Revised (WAI-SR). Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond). Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.

    Measured: 9 weeks following baseline

  7. Treatment satisfaction

    Measured by the Treatment Satisfaction Questionnaire (TSQ). 6 items are scored using various scales. Descriptive statistics are produced for each item.

    Measured: 9 weeks following baseline

  8. Adverse effects

    Measured by questions assessing whether participants encountered any adverse effects of treatment, developed any new psychological symptoms, or experienced any unexpected events over the course of treatment

    Measured: 9 weeks following baseline

  9. Service utilization

    Measured by a series of questions asking participants whether they accessed additional services or support

    Measured: Weeks 9, 13, and 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start30 Sep 2019
  3. Primary completion27 Nov 2020
  4. Study completion27 Nov 2020

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012580
Sponsor's protocol ID
2019-077
Status last verified
Nov 2020
First submitted
4 Jul 2019
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suchan V, Peynenburg V, Thiessen D, Nugent M, Dear B, Titov N, Hadjistavropoulos H. Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Sep 6;6(9):e37216. doi: 10.2196/37216.

    PubMed 36066958

Questions about this trial

What is this clinical trial studying?

A study testing Therapist-assisted ICBT in people with Depression, Postpartum and Anxiety, run by University of Regina 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 8 inclusion and 11 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 29 Apr 2021. 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?

Change in postpartum depression (time frame: Baseline, weeks 1-9, 13, and 37). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04012580, which also lists 1 linked publication.

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 29 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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