Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Depression, Anxiety
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will be a randomized controlled trial (RCT) carried out across three study sites (Ottawa, Denver, Victoria). We will have two study groups, treatment (n=44) and wait-list control (n=44). The wait-list control will be given an online transdiagnostic cognitive-behavioural treatment for depression and anxiety that has been empirically validated. The treatment condition group will be provided 12-15 sessions of Emotionally Focused Therapy for Individuals. Approximately 22 experienced EFT therapists will be given training in EFIT and will provide treatment to 2-3 clients each. Therapy will be carried out in person and/or online.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PROCEDURES Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and...

PROCEDURES Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and within psychotherapy treatment centres. Participants experiencing depression and/or anxiety are invited to contact the research coordinator of the project via the email listed on recruitment material. All interested participants receive a telephone screen by research research assistants to assess potential eligibility. Participants who are deemed potentially eligible are informed that they will be contacted by an assessor to be invited for an initial study assessment session to determine final eligibility. Baseline assessment Assessors are individuals with clinical experience in psychotherapy or counselling at each of the study sites. Informed consent is reviewed and participants have the opportunity to have all their questions and concerns addressed. Assessors administer the diagnostic criteria modules of the ADIS-5 during this session. Assessments take place either within the private practice locations at each study site or the university offices of the investigators in a research session lasting approximately 1-2 hours. During the pandemic while it is not safe to meet in person, secure encrypted video call platforms are used to hold these sessions. Responses are evaluated by the assessors' supervisors, at which point final eligibility is determined. The assessments and therapy take place either within the private practice locations at each study site as specified or the university offices of the co-investigators, or online using a secure encrypted video call platform when it is unsafe to meet for in-person sessions due to the pandemic. After completion of the baseline assessment session, eligible participants are given access to an online questionnaire to complete at their own convenience. After completion of the questionnaire, participants are randomly assigned to study condition. Random assignment Once participants have been deemed eligible to take part, and have completed the baseline questionnaire, they are randomly assigned to the EFIT (treatment) condition or the waitlist plus online CBT (control group) condition by the research co-ordinator. A list of numbers (i.e., 1-40 for Ottawa, 1-28 for Victoria, and 1-20 for Denver) are generated for each city, reflecting the total number of EFIT and control clients for that city. Within those groups, a separate randomized list (i.e., 20 total numerical values for Ottawa, 14 for Victoria, and 10 for Denver) is generated using Research Randomizer, an online tool for random assignment that has been used in previous RCT studies. As participants are deemed eligible, they are added onto the list and their number will determine whether they will take part in either the EFIT intervention or the control group. Interventions: EFIT Treatment Group Twenty-two experienced EFT therapists trained in the EFIT model will provide 15 sessions of EFIT treatment to approximately 2 clients each. Therapy will be carried out in private practices or the university offices of researchers located in each of the study sites, or online using a secure encrypted video call platform when not possible to meet in person due to the pandemic. Each site is associated with an EFT centre: Ottawa Institute of Couple and Family Therapy in Ottawa, Centre for EFT Vancouver Island in Victoria, and Colorado Centre for EFT in Denver. Study therapists will receive an average of 1 hour of supervision per week in groups of 3-4 therapists. Each therapy session will be video recorded and treatment fidelity will be confirmed through the coding of video tapes. After each therapy session, therapists will ask participants to complete a brief online questionnaire that takes approximately 10 minutes to complete. The link to the online questionnaire will be sent to each therapist by the research co-ordinator. Wait-List plus online CBT Control Group Participants randomly assigned to the wait-list control group will wait 15 weeks, following which time they will be given an online transdiagnostic cognitive-behavioural treatment (MoodGym) for depression and anxiety that has been empirically validated after they have completed the 15-week wait period. They will be given access to complete 15 weeks of the online intervention. These participants will also be requested to complete a brief online questionnaire on a weekly basis - this questionnaire is identical to the questionnaire given to EFIT participants after each therapy session with the exception that it does not include the Working Alliance Inventory (WAI) or the Post-session Resolution Questionnaire (PSRQ) as these questionnaires are only relevant to therapy sessions.

Tracking Information

NCT #
NCT04719780
Collaborators
International Centre for Excellence in Emotionally Focused Therapy
Investigators
Principal Investigator: Stephanie Wiebe, PhD Saint Paul University