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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012580
• Other study ID #: 2019-077
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: November 27, 2020

Study information

• Verified date: November 2020
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 27, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline, weeks 1-9, 13, and 37
Secondary	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.	Baseline, 8 weeks, 1 month, and 6 months
Secondary	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.	Baseline, weeks 9, 13, and 37
Secondary	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.	Baseline, weeks 9, 13, and 37
Secondary	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.	Baseline and week 9
Secondary	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.	9 weeks following baseline
Secondary	Treatment satisfaction	Measured by the Treatment Satisfaction Questionnaire (TSQ). 6 items are scored using various scales. Descriptive statistics are produced for each item.	9 weeks following baseline
Secondary	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	9 weeks following baseline
Secondary	Service utilization	Measured by a series of questions asking participants whether they accessed additional services or support	Weeks 9, 13, and 37