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Completed

NCT Number: NCT04012580

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

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.

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Key information

Conditions

Depression, Postpartum Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in postpartum depression

    Time frame: Baseline, weeks 1-9, 13, and 37

    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.

  2. Change in anxiety

    Time frame: Baseline, weeks 1-9, 13, and 37

    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.

Secondary outcomes

  1. Change in depression

    Time frame: Baseline, weeks 1-9, 13, and 37

    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.

  2. Change in depression, anxiety, stress

    Time frame: Baseline, 8 weeks, 1 month, and 6 months

    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.

  3. Mother-infant bonding

    Time frame: Baseline, weeks 9, 13, and 37

    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.

  4. Relationship satisfaction

    Time frame: Baseline, weeks 9, 13, and 37

    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.

  5. Treatment credibility

    Time frame: Baseline and week 9

    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.

  6. Therapeutic alliance

    Time frame: 9 weeks following baseline

    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.

  7. Treatment satisfaction

    Time frame: 9 weeks following baseline

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

  8. Adverse effects

    Time frame: 9 weeks following baseline

    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. Service utilization

    Time frame: Weeks 9, 13, and 37

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

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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