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AnxietyNCT01901796

Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial

A study testing Cognitive Behavioral Therapy in people with Anxiety and Depression, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping… Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
1 siteCanada
Study dates
Jan 2014to Dec 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 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women will be eligible for Phase 2 if they are:
  • < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
  • able to speak/read English; and (3) willing to complete email questionnaires

Who cannot join

  • >28 weeks gestation
  • unable to speak/read English
  • unable to complete email questionnaires

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Westview Health Centre

    Stony Plain, Alberta, T7Z 2M7

Other trials in Canada

About this study

Official title: Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.

We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.

Read the detailed description

One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires.

However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.

Conditions
Anxiety, Depression
Keywords
Anxiety, Depression, CBT
Medical subject headings
Anxiety Disorders, Depression

What participants receive

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

  • Cognitive Behavioral TherapyBehavioural

    Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.

Study groups in NCT01901796
Study groupRoleWhat they receive
Screening and CBTExperimentalScreening and Cognitive Behavioral Therapy. The intervention group will be screened and if they need criteria they will complete the 6, 30-minute online, interactive CBT modules over 6 weeks.
Receives: Behavioral: Cognitive Behavioral Therapy
Usual careNo interventionUsual prenatal care

What is being measured

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

  1. The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.

    Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group. The field does not allow for all questions to be provided. Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you

    Measured: 6 weeks post randomization

Secondary outcomes (7)

  1. Maternal depression, anxiety, stress

    Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire

    Measured: on recruitment, 6 weeks post randomization and 3 months postpartum

  2. Maternal coping

    The Brief Cope Self-reported by mother on emailed questionnaire

    Measured: on recruitment, 6 weeks post-randomization and 3 months postpartum

  3. Relationship Adjustment

    Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire

    Measured: on recruitment, 6 weeks post-randomization and 3 months postpartum

  4. Parenting Stress

    Parenting Stress Scale Self-reported by mother

    Measured: 3 months postpartum

  5. Parenting competence

    Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire

    Measured: 3 months postpartum

  6. Maternal-infant attachment

    Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire

    Measured: 3 months postpartum

  7. Trait anxiety

    State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire

    Measured: on recruitment, 6 weeks postrandomization, 3 months postpartum

Timeline

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

  1. First posted17 Jul 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

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
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01901796
Sponsor's protocol ID
00036912
Status last verified
Nov 2019
First submitted
10 Jul 2013
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Bright KS, Stuart S, Mcneil DA, Murray L, Kingston DE. Feasibility and Acceptability of Internet-Based Interpersonal Psychotherapy for Stress, Anxiety, and Depression in Prenatal Women: Thematic Analysis. JMIR Form Res. 2022 Jun 10;6(6):e23879. doi: 10.2196/23879.

    PubMed 35687403

  • Bright KS, Mughal MK, Wajid A, Lane-Smith M, Murray L, Roy N, Van Zanten SV, Mcneil DA, Stuart S, Kingston D. Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):814. doi: 10.1186/s13063-019-3897-z.

    PubMed 31888712

  • Kingston D, Austin MP, Hegadoren K, McDonald S, Lasiuk G, McDonald S, Heaman M, Biringer A, Sword W, Giallo R, Patel T, Lane-Smith M, van Zanten SV. Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT). Trials. 2014 Mar 6;15:72. doi: 10.1186/1745-6215-15-72.

    PubMed 24597683

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Anxiety and Depression, run by University of Calgary 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. 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?

Results are not available in the source record.

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?

The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. (time frame: 6 weeks post randomization). 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 NCT01901796, which also lists 3 linked publications.

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 13 Nov 2019.

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