A Couples' Intervention Protocol for PTSD

NCT05045859 | Unknown

• 1 other identifier: 11022021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is a multifaceted disorder resulting from intense and/or life-threatening trauma. PTSD sequelae often have a ripple effect on close others, including spouses and children. Studies report high levels of relationship distress for both those with PTSD and their partners as well as emotional distress. Despite the extensive knowledge on the effects of PTSD on couple relations and vice versa, and the limitations of individual therapies in addressing these issues, there has been a major lag in the development and study of couples' interventions in the context of PTSD. the current study will examine the efficacy of Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD. It will employ an RCT to examine both outcomes and processes of change via multiple methods of assessment, including self-report questionnaires, qualitative interviews and physiological co-regulation measures. Moreover, it will employ a modified procedure via video conference due to COVID-19 in addition to in-person treatment option. The study will therefore contribute to theoretical understandings of the effects of PTSD on couples, to the development of therapies specifically intended for such couples.

Conditions

Psychological Trauma

Keywords

post traumatic stress disorder; Cognitive-Behavioral Conjoint Therapy (CBCT); couples therapy; cognitive behavioral therapy (CBT); heart rate variability (HRV); Randomized controlled trial; telepsychology; conference video

Outcome Measures

Primary Outcomes (4)

• Clinician-Administered PTSD Scale (CAPS-5)

  The CAPS-5 (80) is a structured clinical interview designed to assess PTSD. A life-event checklist of traumatic events included in the instrument allows for an assessment of trauma history. Each question on the CAPS-5 corresponds to a DSM-5 criterion for PTSD. Diagnosis used the severity score cutoff of 2 (moderate/threshold) or greater on a scale ranging from 0 (absent) to 4 (extreme). The number of symptoms that meet the cutoff within each subscale is then compared against diagnostic criteria to determine whether a PTSD diagnosis is appropriate. Moreover, the CAPS-5 includes items assessing social, occupational, and overall impairment, global PTSD symptom severity, and validity of the individual report.

  8 months

• PTSD Checklist (PCL-5)

  The PCL-5 is a 20-item self-report questionnaire assessing PTSD symptom severity based on DSM-V criteria. Items are rated on a five-point scale ranging from 0 (not at all) to 4 (extremely). The PCL-5 is well validated, with good internal consistency, test-retest reliability, and convergent and discriminant validity

  8 months

• Physiological couples' co-regulation

  Physiological monitoring of both partners will be conducted at T1 and T3, as well as in 6 therapy sessions. Physiological measures will be assessed using the MindWare Mobile Recorder, that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements, and respiratory activity. Both spouses are fitted with specialized electrodes to measure ECG (for the derivation of HRV), and GSR (for the derivation of electrodermal activity from the skin). At T1, to assess a baseline level of physiological co-regulation the study will utilize a lab-based method with stationary physiological equipment. Participants will complete an adapted videotaped dyadic interaction before and after the intervention. Couples will share and discuss a negative context: the effects of the PTSD on their relationship; and a positive context: a positive experience they've undergone together.

  4 months

• Dyadic Adjustment Scale (DAS)

  A 32-item measure of relationship quality. The scale is divided into 4 subscales: 1. Dyadic Consensus - degree to which respondent agrees with partner 2. Dyadic Satisfaction -- degree to which respondent feels satisfied with partner 3. Dyadic Cohesion -degree to which respondent and partner participate in activities together 4. Affectional Expression -degree to which respondent agrees with partner regarding emotional affection. higher scores represent greater relationship satisfaction.

  8 months

Secondary Outcomes (11)

• The Patient Health Questionnaire-9 (PHQ-9)

  8 months

• Difficulties in Emotion Regulation (DERS)

  8 months

• Perceived Partner Responsiveness (PPR)

  8 months

• the self-disclosure index (SDI)

  8 months

• Conflict Tactic Scale (CTS)

  8 months

Study Arms (2)

CBCT for PTSD

EXPERIMENTAL

CBCT for PTSD is a 15-session, manualized therapy developed by Monson and Fredman, designed to simultaneously improve PTSD symptoms and enhance relationship functioning.

Behavioral: CBCT for PTSD

No Intervention: Wait- List Controls (WL)

NO INTERVENTION

Patients in wait- list control arm received no active treatment during their 15-weeks waiting period. At the end of that period received the exact intervention as the study group.

Interventions

CBCT for PTSD BEHAVIORAL

CBCT for PTSD is a 15-session, manualized therapy developed by Monson and Fredman, designed to simultaneously improve PTSD symptoms and enhance relationship functioning. It assumes that PTSD exists within the couple's relationship and that partners can join together to reduce the presence of PTSD in their relationship. Sessions are organized into three phases of treatment: (1) psychoeducation about PTSD and relationships; (2) behavioral interventions to enhance relationship functioning; and (3) dyadic cognitive intervention designed to contextualize trauma memories and address trauma-relevant cognitions held by either partner that keep the PTSD and/or relationship distress alive. Out-of-session assignments are designed to assist the couple in reinforcing skills learned in the sessions.

CBCT for PTSD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a cohabiting partner or spouse and both spouses must commit to staying in the relationship through 15 sessions of CBCT for PTSD
• have a current diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition \[DSM-5\]; \[2\]), assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5;80)
• not participate in concurrent psychotherapies directly targeting PTSD (e.g., eye movement desensitization and reprocessing; present centered therapy; PE) or concurrent couples therapy

You may not qualify if:

• unmanaged active psychosis or manic episode (assessed with Yale University PRIME Screening Test)
• substance use disorder warranting primary substance use treatment or detoxification (assessed with AUDIT;109 and DAST-10;110\])
• Imminent suicidal risk (assessed with Paykel questionnaire;111)
• severe physical, verbal or cyber aggression currently or in the past 3 months (assessed with CARS;112 and CTS-2;84)
• a current PTSD diagnosis for both spouses (assessed with CAPS-5;80).

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead

Study Sites (1)

Bar- Ilan University

Ramat Gan, 5290002, Israel

RECRUITING

Related Publications (17)

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  PMID: 15229303 BACKGROUND

• Kulka RA, Schlenger WE, Fairbank JA, Hough RL, Jordan BK, Marmar CR, et al. Trauma and the Vietnam War Generation: Report of Findings from the National Vietnam Veterans Readjustment Study. New York: Brunner/Mazel; 1988.

  BACKGROUND

• Skodol AE, Schwartz S, Dohrenwend BP, Levav I, Shrout PE, Reiff M. PTSD symptoms and comorbid mental disorders in Israeli war veterans. Br J Psychiatry. 1996 Dec;169(6):717-25. doi: 10.1192/bjp.169.6.717.

  PMID: 8968629 BACKGROUND

• Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.

  PMID: 7492257 BACKGROUND

• Thorp SR, Stein MB. Post-traumatic stress disorder and functioning. PTSD Res Q. 2005;16(3):1- 8.

  BACKGROUND

• Lambert JE, Engh R, Hasbun A, Holzer J. Impact of posttraumatic stress disorder on the relationship quality and psychological distress of intimate partners: a meta-analytic review. J Fam Psychol. 2012 Oct;26(5):729-37. doi: 10.1037/a0029341. Epub 2012 Aug 27.

  PMID: 22924422 BACKGROUND

• Taft CT, Watkins LE, Stafford J, Street AE, Monson CM. Posttraumatic stress disorder and intimate relationship problems: a meta-analysis. J Consult Clin Psychol. 2011 Feb;79(1):22-33. doi: 10.1037/a0022196.

  PMID: 21261431 BACKGROUND

• Miller MW, Wolf EJ, Reardon AF, Harrington KM, Ryabchenko K, Castillo D, Freund R, Heyman RE. PTSD and conflict behavior between veterans and their intimate partners. J Anxiety Disord. 2013 Mar;27(2):240-51. doi: 10.1016/j.janxdis.2013.02.005. Epub 2013 Mar 4.

  PMID: 23523947 BACKGROUND

• Riggs DS, Byrne CA, Weathers FW, Litz BT. The quality of the intimate relationships of male Vietnam veterans: problems associated with posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):87-101. doi: 10.1023/A:1024409200155.

  PMID: 9479678 BACKGROUND

• LaMotte AD, Taft CT, Reardon AF, Miller MW. Agreement between veteran and partner reports of intimate partner aggression. Psychol Assess. 2014 Dec;26(4):1369-74. doi: 10.1037/pas0000018. Epub 2014 Sep 29.

  PMID: 25265413 BACKGROUND

• Lunney CA, Schnurr PP. Domains of quality of life and symptoms in male veterans treated for posttraumatic stress disorder. J Trauma Stress. 2007 Dec;20(6):955-64. doi: 10.1002/jts.20269.

  PMID: 18157892 BACKGROUND

• Monson CM, Fredman SJ. Cognitive-Behavioral Conjoint Therapy: Harnessing the Healing Power of Relationships. New York, NY: Guilford Press; 2012.

  BACKGROUND

• Glynn SM, Eth S, Randolph ET, Foy DW, Urbaitis M, Boxer L, Paz GG, Leong GB, Firman G, Salk JD, Katzman JW, Crothers J. A test of behavioral family therapy to augment exposure for combat-related posttraumatic stress disorder. J Consult Clin Psychol. 1999 Apr;67(2):243-51. doi: 10.1037//0022-006x.67.2.243.

  PMID: 10224735 BACKGROUND

• Monson CM, Macdonald A, Fredman SJ, Schumm JA, Taft C. Empirically supported couple and family therapies for PTSD. In: Friedman MJ, Terence MK, editors. Handbook of PTSD: Science and Practice, 2nd ed. New York, NY: The Guilford Press; 2014. p. 451-65.

  BACKGROUND

• Trautmann S, Wittchen HU. Trauma and PTSD in Europe. In: Marmar CB, Nemeroff CR, editors. Post-Traumatic Stress Disorder. New York, NY: Oxford University Press; 2018. p. 133-46.

  BACKGROUND

• Sexton T, Gordon KC, Gurman A, Lebow J, Holtzworth-Munroe A, Johnson S. Guidelines for classifying evidence-based treatments in couple and family therapy. Fam Process. 2011 Sep;50(3):377-92. doi: 10.1111/j.1545-5300.2011.01363.x.

  PMID: 21884076 BACKGROUND

• Rodgers B, Elliott R. Qualitative methods in psychotherapy outcome research. In: Gelo O, Pritz A, Rieken B, editors. Psychotherapy Research: Foundations, Process, and Outcome. Vienna: Springer-Verlag; 2015. p. 559-78.

  BACKGROUND

MeSH Terms

Conditions

Psychological Trauma; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rachel Dekel, Prof.

  Bar Ilan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dekel, prof.

CONTACT

+972522956712; Rachel.Dekel@biu.ac.il

Danny Horesh, prof.

CONTACT

+972544332608; Danny.Horesh@biu.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, therapists, investigators and outcome assesors are blind to the condition the individual participant was assigned to, by encrypting the names of the individual into a number-letter codes.The therapists led the intervention group was not aware of the participants condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Model Details: The study will be based on an RCT design. The screening process will consist of an initial phone call and two video conference sessions, to assess eligibility. Eligible Couples will be randomized using block randomization for assignment to two conditions: A CBCT and a waitlist (WL) control. The WL group will be assigned to CBCT after the waiting period. The design includes four points of assessment: Pre-treatment/pre-WL (baseline) (T1); during treatment/waiting period (T2 - different measures at various intervals); post-treatment/post-waiting period (T3); and at a 4-month follow-up (T4). Self- report measures will be administered at all time-points. A dyadic communication lab interaction will be conducted at T1 \& T3. At T2, PTSD and marital satisfaction will be measured in every session. physiological monitoring will be conducted at T1 and T3, and at six out of 15 sessions. qualitative interviews with a randomly selected sub-sample (N=12) will take place at T1 and T3.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 16, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IL (1)