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

NCT ID: NCT04012580

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-11-27

Brief 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. 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.

Conditions

Depression, Postpartum; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapist-assisted ICBT

An 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.

Group Type: EXPERIMENTAL

Therapist-assisted ICBT

Intervention Type: BEHAVIORAL

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.

Treatment as usual control

Participants 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapist-assisted ICBT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcie Nugent, MSW

Role: STUDY_DIRECTOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36066958 (View on PubMed)

Other Identifiers

2019-077

Identifier Type: -

Identifier Source: org_study_id