Research on the LEAP Approach

Paillot C., Goetz R., and Amador, X. (2009). Double Blind, Randomized, Controlled Study of a Psychotherapy [LEAP] Designed to Improve Motivation for Change, Insight into Schizophrenia and Adherence to Medication. Schizophrenia Bulletin, 35(1): 343.

Most patients with DSM-IV schizophrenia exhibit full or partial non-adherence to pharmacological treatment (Rummel-Kluge, 2008). Only about one-third reliably take antipsychotic medication as prescribed (Oehl, 2000). Poor adherence (i.e., both complete and partial non adherence) has been found to be associated with relapse, increased involuntary admissions, poorer course of illness, and increased incidence of violence and suicide (Amador and David 2004). Given the serious outcomes associated with poor adherence interventions aimed at improving and maintaining adherence are of great interest to clinicians, researchers, and policy makers.

Objective: The aim of this study is to assess the efficacy of a psychotherapy based on motivational enhancement and cognitive therapies designed to improve patient’s adherence to treatment and motivation to change (Listen-Empathize-Agree-Partner™, or LEAP™ therapy; Amador, 2007).

Method: 54 patients diagnosed with schizophrenia about to be discharged following inpatient treatment were included in a six month repeated measures longitudinal study. Patients were randomly assigned to either the experimental or control therapies. Subjects did not know whether they were receiving the experimental versus control therapy. All patients were treated with long acting injectable antipsychotic medications (either typical or atypical) and rated as compliant when the injection was confirmed and non compliant if the injection was refused or the appointment for the injection was missed. Insight into schizophrenia and attitudes toward treatment were assessed using the Scale to assess Unawareness of Mental Disorder, the Birchwood Insight Scale and the Drug Attitude Inventory, respectively. All assessments were made by a single rater who was blind to group assignment.

The results show that compared to the control psychotherapy the experimental intervention improved motivation for change, insight and adherence to treatment.

Conclusion: This study found LEAP™ to be superior to the control psychotherapy. LEAP™ improved compliance, motivation for change, insight and attitudes towards treatment. Strengths of the experimental design include the randomized blinded group assignment, blinded assessments of the dependent variables and near 100% reliability and validity of the adherence measure. Among the limitations of the present study was the absence of a LEAP™ fidelity measure and the fact that the senior author was the only therapist for all patients and as such could have biased the results by differentially treating patients depending on which therapy they were assigned to. This study will be replicated in a larger more heterogeneous sample with a longitudinal assessment of fidelity to the LEAP™ intervention and a therapist(s) blinded to study hypotheses.

Key words: compliance;  poor adherence to treatment, insight, awareness of mental disorders, motivation to change, schizophrenia, Long-acting injectable’s.

            The present study evaluated the efficacy of a Listen-Empathize-Agree-Partner (LEAP) educational program for relatives of people with severe mental illness who also lack awareness of their illness.  It was hypothesized that relationship variables would improve such as perceived alliance between the respondent and the relative, as well as emotional experience of the relative, psychosocial functioning, medication adherence, and quality of life outcomes.

            We recruited individuals (N=227) who had completed a LEAP training within the last month and asked them to evaluate their relationship with and quality of life of their relative during the two weeks prior to the LEAP training. A second wave of evaluation was conducted at three months post training (N=88) with respondents focusing on the present time.

            Questions assessing alliance and perceived emotional experience of the relative developed for a previous LEAP study for which factor analysis showed reliable factor structures aligned with the constructs were used.  Medication adherence was assessed with a slightly modified version of the Clinician Rating Scale by Kemp et al.. Questions focused on the Stages of Change Model assessed motivation toward taking medication, staying connected with one’s family, employment, housing, and recovery if the relative also struggles with substance abuse.  Social engagement, interpersonal relationships, social activities, recreation, and independence questions were included.

            The results show statistically significant improvement in alliance, interpersonal relationships, social activities, and independence.  Qualitative findings based on open ended questions regarding quality of the relationship and the relative’s life goals are also in the hypothesized direction.