NCT03103217

Brief Summary

Pregnancy is a time of significant adjustment and uncertainty. Anxiety is common among this group and is associated with poor cognitive and physical outcomes for both the mother and child. Few trials have been conducted to ascertain the effectiveness of brief psychological interventions designed to alleviate general anxiety, labour and pregnancy specific anxiety and promote well being. The aim of this project is to establish if a brief Cognitive Behavioural Therapy treatment is effective in reducing general anxiety during pregnancy. The study will also explore whether the treatment has an impact on reducing pregnancy specific and labour related anxiety and reducing medical intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

March 21, 2016

Last Update Submit

May 6, 2024

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to post intervention and at follow-up -Hospital depression and anxiety scale

    baseline, 2 weeks and 2 months

Secondary Outcomes (3)

  • Change from Baseline to post intervention - Pregnancy Related Anxiety Questionnaire - Short

    baseline and 2 weeks

  • Change from Baseline to post intervention and at follow-up - The Warick Edinburgh Mental Well-being scale

    baseline, 2 weeks and 2 months

  • Childbirth experience questionnaire

    2 months only

Study Arms (1)

Brief CBT intervention

EXPERIMENTAL
Behavioral: brief CBT for anxious pregnant women

Interventions

brief CBT for anxious pregnant womenBEHAVIORAL

one off 3 hour session including psychoeducation, exploration of cognitions and experiential practice of behavioural techniques.

Brief CBT intervention

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Pregnant woman
  • Referred to group and screened for suitability
  • Attended brief pregnancy session
  • Contact with community midwife
  • General anxiety (Score \>8 on HADS)
  • Able to read, write and understand English
  • Aged over 16
  • Ability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Ross

Aberdeen, Scotland, AB24 5RN, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Paul Morris, Health Psychology

    University of Edinburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 6, 2017

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

April 30, 2017

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)