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

NCT04012580 | Completed

• 1 other identifier: 2019-077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

postpartum; depression; anxiety; internet-delivered cognitive behaviour therapy; randomized controlled trial; therapist-assistance

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, weeks 1-9, 13, and 37

• 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.

  Baseline, weeks 1-9, 13, and 37

Secondary Outcomes (9)

• Change in depression

  Baseline, weeks 1-9, 13, and 37

• Change in depression, anxiety, stress

  Baseline, 8 weeks, 1 month, and 6 months

• Mother-infant bonding

  Baseline, weeks 9, 13, and 37

• Relationship satisfaction

  Baseline, weeks 9, 13, and 37

• Treatment credibility

  Baseline and week 9

Study Arms (2)

Therapist-assisted ICBT

EXPERIMENTAL

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.

Behavioral: Therapist-assisted ICBT

Treatment as usual control

NO INTERVENTION

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.

Interventions

Therapist-assisted ICBT 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.

Therapist-assisted ICBT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (1)

• 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.

  PMID: 36066958 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Marcie Nugent, MSW

  University of Regina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: September 30, 2019
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: April 29, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)