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A Randomized Controlled Trial of Imago Relationship Therapy

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ClinicalTrials.gov Identifier: NCT04302844
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Hembree, PhD, University of Pennsylvania

Brief Summary:
The primary goal of this study, A Randomized Controlled Trial of Imago Relationship Therapy, is to evaluate the efficacy of Imago Relationship Therapy, a form of couples therapy.

Condition or disease Intervention/treatment Phase
Relationship Disorder Behavioral: Imago Relationship Therapy Behavioral: Waitlist with Bibliotherapy followed by Workshop Not Applicable

Detailed Description:
Imago relationship therapy (IRT; Hendrix, 2008) is an integrative approach to couples therapy that has been practiced and extensively disseminated for more than 30 years. IRT may be delivered through traditional therapy with a couple, or the Imago principles and skills may be taught to couples through the "Getting the Love You Want" Workshop (GTLYW Workshop), a manualized, 2-day, psychoeducational workshop conducted by certified presenters to groups of couples. The present study is a RCT designed to examine the efficacy of IRT for couples experiencing distress in their committed romantic relationships, and to extend the findings of previous research. Seventy-two (72) couples with relationship distress will be recruited for the study. Couples will be randomly assigned to one of two conditions: Imago therapy alone or bibliotherapy, a control condition, in which couples will be given a self-help book on dyadic communication to read during a 12-week waiting period, followed by a GTLYW workshop.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Independent Evaluators are blind to treatment condition
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Imago Relationship Therapy
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Active Comparator: Imago Relationship Therapy (IRT)
Couples will receive 12 to 16 Imago relationship therapy sessions (90 minutes each; one session per week) with an experienced and certified Imago Relationship therapist.
Behavioral: Imago Relationship Therapy
Imago relationship therapy (IRT) involves learning the Imago dialogue process, which helps couples understand more clearly why they and their partners react as they do. Couples practice communicating in a manner that helps them move from reactivity and blame to understanding and empathy. The dialogue is used to transform conflicts into opportunities for healing and growth, and to connect more deeply and effectively with one another. Specific topics of therapy are determined by the couple's needs and goals. In general, the therapist helps them use the Imago dialogue to promote understanding, heal painful emotions, and make requests of one another to change behaviors. In effort to minimize risk of exposure to the virus that causes COVID-19, since the spring of 2020, therapy sessions will be conducted via telehealth, with a HIPAA-compliant audio/visual platform, and with couples at home or in another private place during the therapy sessions and the therapist in his or her office.
Other Name: Imago Relationship Therapy (IRT)

Active Comparator: Waitlist with Bibliotherapy followed by Workshop
Couples will be asked to wait for 12 weeks before receiving any intervention, and will be given a relationship-focused self-help book to read during that time. After 12 weeks and the 12-week assessment has been completed, couples will receive a Getting the Love You Want workshop.
Behavioral: Waitlist with Bibliotherapy followed by Workshop
Participants assigned to this group will be asked to wait for 12 weeks before receiving any intervention, and will be given a relationship-focused self-help book to read, with exercises to practice, during that time. After 12 weeks and the 12-week assessment has been completed, couples will attend an educational workshop that provides the principles and communication skills of Imago Relationship Therapy, typically in a weekend format that is usually about 18-20 hours. The workshops, called "Getting the Love You Want (GTLYW)", are led by certified and experienced Imago workshop presenters, and are attended by a group of couples. The workshop includes presentations, discussions, and practice of communication exercises. Participation in the workshops will also be virtual or via telehealth, as described above.




Primary Outcome Measures :
  1. Change in Relationship Quality Interview (RQI) [ Time Frame: 3 to 4 months ]
    The RQI (Lawrence, Barry, Brock, Bunde, Langer, Ro, et al., 2011) is semi-structured, behaviorally anchored individual interview that takes about 60 minutes to administer. The RQI provides an objective assessment of relationship quality as a dynamic dyadic construct across 5 dimensions: (a) quality of emotional intimacy in the relationship, (b) quality of the couple's sexual relationship, (c) quality of support transactions in the relationship, (d) quality of the couple's ability to share power in the relationship, and (e) quality of conflict/problem-solving interactions in the relationship. The RQI will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  2. Change in Marital Adjustment Test (MAT) [ Time Frame: 3 to 4 months ]
    A 15-item self-report questionnaire that measures relationship satisfaction. The scale focuses on issues such as involvement in joint activities, demonstration of affection, frequency of marital complaints, level of loneliness and well-being, and partner agreement on significant issues. The MAT will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.


Secondary Outcome Measures :
  1. Change in Dyadic Adjustment Scale (DAS) [ Time Frame: 3 to 4 months ]
    A 32-item self-report inventory designed to measure satisfaction in intimate dyads. It is a commonly used inventory and has good psychometric properties. The 19 items of the DAS that do not overlap with the MAT will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  2. Change in Davis Interpersonal Reactivity Index (IRI) [ Time Frame: 3 to 4 months ]
    The IRI is a 28-item self-report scale that measures both cognitive and affective components of empathy, and consists of four different 7-item subscales, representing different components of interpersonal sensitivity. The IRI is reliable, well validated and widely used (Davis, 1980). The IRI will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  3. Change in Communication Patterns Questionnaire (CPQ) [ Time Frame: 3 to 4 months ]
    The Communication Patterns Questionnaire assesses a person's perceptions of dyadic communication about relationship problems, and yields scores on three subscales: demand/withdraw, criticize/defend, and positive interaction. The CPQ has demonstrated acceptable reliability and validity. The CPQ will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  4. Change in Couple Satisfaction Inventory -16 [ Time Frame: 3 to 4 months ]
    The CSI-16 is a 16-item self-report that measures current degree of relationship satisfaction. Scores can range from 0 to 81. Higher scores indicate higher levels of relationship satisfaction. The scale has good psychometric properties; see Funk, J.L., & Rogge, R.D. (2007). The CSI-16 will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  5. Change in Quick Inventory of Depressive Symptomatology (QIDS SR-16) (Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) [ Time Frame: 3 to 4 months ]
    The QIDS SR-16 is a 16-item self-report measure of depression. It has good internal consistency. The QUIDS SR-16 will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  6. Change in Generalized Anxiety Disorder - 7 (GAD 7; Spitzer, Kroenke, Williams, 2006). [ Time Frame: 3 to 4 months ]
    The GAD 7 is a 7-item scale developed to diagnose generalized anxiety disorders. It has sensitivity of 89% and specificity of 82% and is commonly used as a brief scale with goo reliability and validity. The GAD 7 will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  7. Change in PROMIS Item Bank v1.1 Emotional Distress - Anger Short form 5a [ Time Frame: 3 to 4 months ]
    The PROMIS - Anger Short form 5a is a 5-item self-report measure of general anger that is part of the NIH-funded PROMIS® (Patient-Reported Outcomes Measurement Information System), a set of validated person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. The PROMIS - Anger scale will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  8. Change in PROMIS Item Bank v1.0 Global Satisfaction with Sex [ Time Frame: 3 to 4 months ]
    This PROMIS scale is a 5-item self-report measure of sexual functioning that is part of the NIH-funded PROMIS® (Patient-Reported Outcomes Measurement Information System). The PROMIS Satisfaction with Sex scale will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.

  9. Change in PROMIS Item Bank v1.2 Global Health [ Time Frame: 3 to 4 months ]
    This PROMIS scale is a 10-item self-report measure of general health that is part of the NIH-funded PROMIS® (Patient-Reported Outcomes Measurement Information System). The PROMIS Global Health scale will be used to measure change from: pre-randomization to post-intervention or post-waitlist, and from post-intervention or post-waitlist to 3-month follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Straight or LGBTQ couples; both members at least 18 years of age
  2. Ability to speak and understand, and read and write, in English language
  3. Married/cohabitating for a minimum of 1 year
  4. Currently experiencing relationship distress
  5. Interest in improving relationship satisfaction/have no immediate plans to terminate the relationship
  6. Willingness to participate in study procedures via telehealth and access to the equipment and pricacy required to do so.

Exclusion Criteria:

  1. Current alcohol or substance dependence (with active use) in one or both partners
  2. Serious suicidal ideation and behavior in one or both partners (i.e., ideation with plan or intent)
  3. Current physical violence or partner abuse
  4. One or both partners currently involved in a secret affair (i.e., the partner is unaware of this relationship)
  5. Current couples-focused psychotherapy treatment that is on-going
  6. Couple received IRT or GTLYW workshop within the past 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302844


Contacts
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Contact: Elizabeth A Hembree, PhD 215-573-6075 hembree@pennmedicine.upenn.edu
Contact: Kate Oliver, BS 215-703-7475 kate.oliver@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Mood and Anxiety Disorders Treatment & Research Program Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kate Oliver, BS    215-703-7475    couples-study@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Elizabeth A. Hembree, PhD, Associate Professor of Psychology in Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04302844    
Other Study ID Numbers: 829071
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No