Clinical trial NCT03562962: Assessing the Mechanism of Change of Functional Analytic Psychotherapy
Official title: Assessing the Mechanism of Change of Functional Analytic Psychotherapy: An Analysis of a Process-Driven Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interpersonal Functioning
Psychological Distress
Keywords: Functional Analytic Psychotherapy
Process-Outcome Psychotherapies
Mechanism of change
Interpersonal Functioning
Psychological Distress
Contingencies of reinforcement
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A concurrent experimental multiple baseline design (MBL) across participants with a follow-up phase will be conducted (A/B/Follow-up). Concurrent MBL controls historical factors and other threats to internal validity by sequentially introducing the treatment phase. The latter requires that the length of the baselines varies between participants. Additionally, the MBL allows comparing behavioral data among individuals across different or similar conditions, showing whether extraneous variables affect the participants in the same manner or not. The between-series comparisons control for threats to external and internal validity that might affect individuals in the same study.
Primary purpose: BASIC_SCIENCE

Brief summary: This study seeks to assess the mechanisms of change of Functional Analytic Psychotherapy (FAP). FAP is a process-outcome psychotherapy that focuses on the therapeutic relationship, providing services to participants presenting with difficulties in their social interactions and relationships. A multiple baseline design between four participants who report interpersonal relating difficulties and psychological distress will be conducted. Therapists will provide contingent reinforcement to clients' behavior in session with the aim of:

1. Examining the mechanisms of change of FAP via contingent responding to participants' interpersonal difficulties.
2. Determining the effectiveness of FAP on the interpersonal functioning of verbally able adults.
3. Establishing the relationship between the amount of contingent reinforcement and the changes in clients' interpersonal repertoires (proportion).

Four hypotheses will be explored in this study: (1) contingent reinforcement functions as the mechanism of change in FAP, (2) FAP implementation decreases the frequency of interpersonal problems in and out of session, (3) FAP implementation increases the frequency of interpersonal functioning in and out of session, and (4) a higher proportion of reinforcement delivered by therapist enhances clients' alternative behaviors.

Detailed description: The interest for supporting process-outcome psychotherapies has increased in recent years. With the aim of finding parsimonious and precise interventions for specific populations under particular circumstances, clinical researchers have supported the development of principle-driven research. Studies discussed the importance of conducting translational research to identify psychotherapy mechanisms of change in order to match those interventions with psychological problems maintained by similar variables. In the long term, it is expected that process-outcome psychotherapies will reduce the burden produced by the overload of psychological interventions that share similar mechanisms of change but have been treated as independent therapeutic packages. Likewise, it is anticipated that process-outcome psychotherapies will reduce relapse frequency by targeting specific mechanisms of change. They would also enhance efficiency since they will reduce the use of therapeutic procedures that do not target the most important variables in producing therapeutic change.

Functional Analytic Psychotherapy (FAP) is a process-outcome psychotherapy that produces changes in interpersonal relating behaviors by modifying the contingencies of reinforcement of clients' behavior. Reinforcement, as a behavioral mechanism of change, explains the increment on the probability of occurrence of the behavior and its maintenance. FAP focuses on improving the effectiveness of clients' interpersonal behaviors by providing social contingencies of reinforcement to clients' responses within the therapeutic setting. Though there are several studies and reports that support the effectiveness of FAP, few studies have explored the specific mechanisms of change. Some studies have explored the effects of therapists' contingent responding to clients' ineffective behavior. However, they have lacked analyses of conditional relationships between clients and therapists' responses. This research, therefore, will provide information about the mechanism of change underlying FAP by studying the conditional relations of contingencies of reinforcement and clients' behaviors in the context of a meaningful therapeutic relationship.

Method

Study aims:

1. To examine the mechanisms of change of Functional Analytic Psychotherapy (FAP) via contingent responding to participants' interpersonal difficulties
2. To determine the effectiveness of FAP on the interpersonal functioning of verbally able adults.
3. To establish the relation between the amount of contingent reinforcement and the changes in clients' interpersonal repertoires.

Variables:

Dependent. Interpersonal relating difficulties comprise behaviors that interfere with social functioning. In Callaghan's words, "\[t\]hese problems are based on the function of behaviors as they impact the client's ability to form effective interpersonal relationships". Lastly, interpersonal difficulties are defined based on the effects these produce on the individual's the social environment (function). Behavior analysis identifies two types of operant functions that characterize classes of behavior: positive reinforcement, a process by which behaviors are strengthened following the delivery of a consequence, and negative reinforcement, where behaviors are strengthened by the withdrawal of a potentially aversive consequence.

Callaghan developed the Functional Idiographic Assessment Template (FIAT), a functional based classification for interpersonal difficulties. The FIAT described repertoires based on the antecedent stimulus control and the behavioral patterns (which include the contingency of reinforcement). Five functional interpersonal classes will be object of intervention in this study: (a) assertion of needs (including social support), (b) bidirectional communication, (c) conflict, (d) disclosure and interpersonal closeness (disclosing and seeking intimacy), and (e) emotional experience and expression. Problems in the FIAT classes (CRB1s) will be modified by altering the contingencies of reinforcement as specified in the description of the independent variable, aiming increasing improvements in these functional classes (CRB2s).

Independent. FAP is a therapeutic procedure based on behavior analytic principles. This approach seeks to implement procedures to manipulate the contingencies of reinforcement involved in problem and alternative behaviors within the context of a meaningful therapeutic relationship in the clinical setting that is functionally equivalent to those out-of-session.

According to the behavior analytic perspective, there are two main processes (functions of behavior) that are targeted to influence individuals' behavior: contingencies of reinforcement (process that maintains elevations or increases behavior probability) and antecedent stimulus control, which involves a set of conditions under which the responses are more likely reinforced. A discriminative stimulus (SD) indicates that reinforcement is available, whereas a Delta stimulus (SΔ) signals an extremely low probability for reinforcement of behavior. These functional relations are identified using a functional behavioral assessment. FAP intends to modify CRBs by utilizing therapists contingent responding (TCRB). That is, FAP proposed to implement differential reinforcement (TCRB1) to reduce CRB1s and to provide positive reinforcement to enhance CRB2s. Based on the changes within the therapeutic setting, clients are prompted to discriminate contexts where those repertoires are likely reinforced and generalize those responses to such environments.

Design:

A non-concurrent experimental multiple baseline design (MBL) across participants with a follow-up phase will be conducted (A/B/Follow-up). Concurrent MBL controls historical factors and other threats to internal validity by sequentially introducing the treatment phase. The latter requires that the length of the baselines varies between participants. In this study, the baselines per each participant will be assigned in this order: three sessions to the participant 1, five sessions to the participant, six sessions to participant 3, and seven sessions to participant 4.

Additionally, the MBL allows comparing behavioral data between individuals across different or similar conditions, showing whether extraneous variables affect the participants in the same manner or not. The between-series comparisons control for historical factors or other threats to external and internal validity that might affect individuals in the same study.

Within the baseline (A), Supportive Listening (SL) will be provided, which has been widely utilized in randomized control trials, including the only Randomized Control Trial (RCT) conducted in FAP (Maitland \& Gaynor, 2016), as a control condition. SL is defined as "a psychological treatment in which therapists do not engage in any therapeutic strategies other than active listening and offering support, focusing on participants' problems and concerns". In this therapy, the therapist reflects on clients' experiences and encourage them to share emotional experiences. Therapists are prohibited from giving advice, making interpretations, and providing feedback to clients. FAP will be introduced at phase B, where contingent reinforcement will be administered for increasing clients' goal behaviors (CRB2) and differential reinforcement will be utilized to reduce clients' problem behaviors (CRB1).

Participants:

The study will include four participants. Based on the power analysis performed using the D_power macro, the study will have a power of .962 (high power). They will be recruited using flyers that will be posted on public billboards on University campus (University of Nevada, Reno). Third party (or snowball sampling) procedures will be also utilized. Participants will be recruited through the Psychological Services Center as well as the Student Counseling Center at the University of Nevada, Reno. A flyer with the study and contact instruction information will be provided to these sites with the aim that the potential participants initiate the contact with the researchers subsequently.

Up to 20 participants will be recruited and an eligibility assessment will be conducted by two doctoral students to determine participants enrollment. Potential participants who report interpersonal difficulties and psychological distress will be invited to enroll in the study. Interpersonal functioning will be assessed using the Functional Idiographic Assessment Template-Questionnaire Short Form (FIAT-Q-SF), and psychological distress will be evaluated utilizing the Depression Anxiety Stress Scales (DASS). A clinical interview will be conducted to validate participants' interpersonal and psychological functioning. Individuals who report current substance abuse disorder as defined by the DSM-5, suicidal plan or past suicidal attempts and history of psychotic or bipolar disorder will be excluded and referred to another psychological service provider.

Instruments and Materials:

1. Functional Idiographic Assessment Template-Questionnaire Short Form (FIAT-Q-SF): to identify participants interpersonal functioning outside the therapeutic setting.
2. Depression Anxiety Stress Scales (DASS): to identify participants psychological distress outside the therapeutic setting.
3. The Functional Analytic Psychotherapy-Intimacy Scale (FAP-IS): to identify participants' engagement in a meaningful therapeutic relationship that facilities the action of the mechanism of change in FAP.
4. Working Alliance Inventory-Short Revised (WAI-SF): to identify participants' engagement in a meaningful therapeutic relationship that facilities the action of the mechanism of change in FAP.
5. Functional Analytic Psychotherapy Rating Scale (FAPRS): The FAPRS is a coding system designed for assessing clinical interactions based on behavior analytic principles. This instrument will be employed to evaluate FAP's mechanism of change and therapists' adherence to FAP procedures.
6. Diary Card (Self-report record): to assess participant's interpersonal behaviors outside of session. This format includes three columns where participants describe the antecedents and consequences of their interpersonal behaviors.
7. Noldus Observer XT: this software allows coders to observe and code participants and therapists' behaviors in-session with the aim of assessing the mechanism of change in FAP.

Procedure:

During recruitment, potential participants will be invited to attend 1-hr and a half eligibility assessment session. Before conducting the eligibility assessment, informed consents will be discussed with potential participants according to APA and local IRB standards. Upon participants agree on research participation, interpersonal difficulties and psychological distress will be evaluated. Results of eligibility will be discussed at the end of this session. If a potential participant decides to decline or discontinue his/her participation or does not meet criteria for the study, referral options will be provided using a referral list of the psychological services center (PSC). Assessments will be conducted in the PSC by the therapists in this study.

Following enrollment, SL and clients' history assessment will be conducted (Baseline). At the first three weeks, phase B will be introduced to the first participant at session four and the intervention will be sequentially implemented to the other clients as described in the design section. FAP will be introduced to modify the functions that maintain the interpersonal relating difficulties (nine-weeks per each participant). Finally, a follow-up session will take place one month after completion of the intervention phase, and stability of behavior changes across time will be measured.

Data will be collected on a weekly basis. FIAT-Q-SF and DASS will be administered at the beginning of the session, to assess participants interpersonal functioning and psychological distress out-of-session. WAI-SF and FAP-IS will be administered at the end of therapy and place in a sealed box, to prevent responders' bias on the quality of therapeutic relationship. Scores from these questionaries' will be entered in an Excel sheet within an electronic server encrypted by a blind research assistant. In addition, participants and therapists' behaviors within the therapeutic session will be coded by three blind raters with the aim of assessing the mechanism of change of FAP and the effects of FAP in interpersonal functioning and psychological distress in the session. Video records will be kept safe in an electronic file encrypted storage and a password-protected computer.

For quality assurance, data will be monitored by the principal investigator weekly. The principal investigator will review participants case report forms and conduct meetings with the therapists to oversee the fidelity of research procedures. Adverse reactions will be assessed applying the knowledge the principal investigator has of clinical factors and behaviors that predict and indicate adverse psychological reactions. He also has a vast knowledge in FAP that allows him to detect negative unexpected effects from implementing this intervention. So far, FAP research has not found specific therapeutic factors that would trigger an immediate suspension of the research. If so, the principal investigator will inform local IRB and the study procedures would be re-evaluated or suspended.

Data Analysis Plan:

To examine the mechanisms of change of the FAP via contingent responding to participants' interpersonal difficulties (Aim 1), a state-based lag sequential analysis of participants and therapist behaviors within session will be conducted. The statistical significance of the conditional probabilities will be tested by computing z scores (adjusted residuals). The strength of the association between client and therapist's behavior will be examined by the Yule's Q statistic and a chi-squared test will be performed to identify a significant interdependence within the transitional matrix. In addition, a stack graph will be performed to analyze the relationship between the CRBs and the percentage of contingent reinforcement in the context of a meaningful relationship (FAP-IS).

Effectiveness of FAP on interpersonal difficulties of verbally able adults (Aim 2) will be examined by conducting descriptive statistics and visual inspection of participants' behaviors to compare trends between-subjects. Effect sizes will be determined by calculating Hedge's g correction of standardized effect sizes for singles case designs. A non-overlap analysis of all pairs (NAP) will be conducted as a complementary assessment of the effect sizes of participants' behaviors. In addition, a simulation modelling analysis (SMA) will be performed to establish the relation between FAP and changes in interpersonal difficulties. SMA is an alternative statistical technique that has an acceptable control of Type-I and Type-II errors to analyzed short streams of autocorrelated data, which are typically observed in single case designs. This statistical method simulates datasets similar in length and autocorrelation to the data at hand. Using a bootstrapping, SMA tests if the relationship between the intervention and the dependent variable remains when autocorrelation and data length are similar in thousand (\~5000) of samples.

To establish the relation between the amount of contingent reinforcement and the changes in clients' interpersonal repertoires in session (Aim 3), the proportion of therapists' contingent responses (TCRBs) to CRBs will be calculated. TCRBs' proportion will be plotted and a visual analysis of behavioral trends between participants will be conducted.

Eligibility criteria: Inclusion Criteria:

* Interpersonal Difficulties: participants who endorse high scores in the Functional Idiographic Assessment Template-Questionnaire Short Form (Darrow et al., 2014) and report interpersonal dysfunction in a clinical interview based on the Functional Idiographic Assessment Template (Callaghan, 2001)
* Psychological Distress: participants who endorse indicators of depression, anxiety, stress, or general psychological distress based on the DASS-42 (Crawford \& Henry, 2003) and report psychological distress in a clinical interview.
* Participants who Identify themselves as needing psychological services.

Exclusion Criteria:

* Current substance abuse.
* Current suicidal plan.
* Past suicidal attempts.
* History of psychotic or bipolar disorders.
* Participants who are taking psychiatric medication for less than six weeks.

Primary outcomes:
measure: Functional Idiographic Assessment Template-Questionnaire Short Form (FIAT-Q-SF)
timeFrame: Through study completion, an average of 1 year
measure: Depression Anxiety Stress Scale (DASS-42)
timeFrame: Through study completion, an average of 1 year
measure: Changes in clients Behaviors and therapists responses in session
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Working Alliance Inventory-Short Revised (WAI-SF)
timeFrame: Through study completion, an average of 1 year
measure: The Functional Analytic Psychotherapy-Intimacy Scale (FAP-IS)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: William C Follette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Darrow SM, Callaghan GC, Bonow JT, Follette WC. The Functional Idiographic Assessment Template-Questionnaire (FIAT-Q): Initial Psychometric Properties. J Contextual Behav Sci. 2014 Apr 1;3(2):124-135. doi: 10.1016/j.jcbs.2014.02.002.
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