Comparing efficacy of treatment as usual or treatment with acceptance and commitment therapy (ACT) for stigma and shame in patient with substance use disorder: A randomized control trial
Last registered on March 19, 2020

Pre-Trial

Trial Information
General Information
Title
Comparing efficacy of treatment as usual or treatment with acceptance and commitment therapy (ACT) for stigma and shame in patient with substance use disorder: A randomized control trial
RCT ID
AEARCTR-0005571
Initial registration date
March 18, 2020
Last updated
March 19, 2020 12:11 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2019-01-01
End date
2019-06-01
Secondary IDs
Abstract
Objective: We aimed to examine whether treatment as usual or treatment with ACT was more effective for stigma and shame among substance use disorders (SUD’s).
Method: A double blind, parallel assignment was conducted with 60 adults aged 18–35 years with SUD’s had sought care at one of four clinical centers in Rawalpindi and Islamabad, Pakistan. Patients were randomly assigned (1:1) to receive treatment with ACT or treatment as usual. All participants received ACT, delivered by therapists in 6-hour sessions and attended interviews at baseline. Primary outcomes stigma (enacted, anticipated, internalized)and shame, whereas secondary outcomes such as general health, quality of life, Acceptance and action questionnaire, multidimensional social support all were assessed at pre, post and follow up period with the help of research assistants.
Result: A two-way factorial ANOVA between subjects were performed, scores showed a significant difference between two groups at primary outcomes which are enacted stigma (F=30.44, p=.000, ηp2 = .244), anticipated stigma (F=17.56, P=.000, ηp2 =.157), internalized stigma (F=20.14, P=.000, ηp2 =.176) and shame (F=31.04, P=.000, ηp2 =.247) which all are significant at timeline model.
Conclusion: Results suggest that combined treatment with ACT was more effective for stigma and shame than treatment as usual for SUD’s. This study could serve as a model for designing future RCTs with ACT-related interventions.
Key words: ACT, Treatment as usual, SUD’s.
External Link(s)
Registration Citation
Citation
Gul, Mahvia. 2020. "Comparing efficacy of treatment as usual or treatment with acceptance and commitment therapy (ACT) for stigma and shame in patient with substance use disorder: A randomized control trial." AEA RCT Registry. March 19. https://doi.org/10.1257/rct.5571-1.0.
Experimental Details
Interventions
Intervention(s)
Acceptance and commitment therapy (ACT). The ACT intervention used in this study was designed according to the standards of the Contextual Behavior Science Association (CBSA 2015) and adapted to the needs of the healthy participants. Participants attended a ACT group in place of treatment as usual that would have occurred at the similar time. ACT was delivered by appropriately qualified psychological therapists on an group basis over a period of 3 weeks and included up to 6 h of treatment on an approximately 2 h session per day, with up to one additional booster sessions. A total of four group were made which varied in size from 8 to 10 participants. ACT groups were co-led by two therapists, study analysts included two psychologists and one addictions counselor, each of whom had been conducting ACT groups with substance use disorder patients for at least 2 years. ACT was based on a specific five basic modules (willingness, values, committed action, workability and defusion) and two non-specific targets (stigma and shame). The group sessions were both experiential and didactic, and concentrated on using the processes of psychological acceptance, cognitive defusion, and contact with important values to assist participants learn to respond to their shame or stigmatizing thoughts and behaviors in a way that would not hinder recovery. Acceptance techniques encourage participants to feel problematic feelings more fully while reducing their automatic link to overt action. Cognitive defusion techniques help group members ‘‘deliteralize’’ the content of thoughts – that is, to emphasis more on the process of thinking and the workability of behavior knotted to particular thoughts than on their content. For example, the group generated a particularly potent self-evaluation and reduced it to a single word (e.g., one group arrived at the word ‘‘loser’’). The whole group then repeated that word rapidly out loud for about 30 s, a procedure known to reduce both fusion with thoughts and the distress they induce (Masuda et al. 2004). Mindfulness exercises and metaphors (e.g., watching thoughts like one would watch leaves on a stream) were used to help individuals stay in the present moment and not get ‘‘hooked’’ on thoughts or live in the past or future (Hayes et al. 1999). Participants were encouraged to discover their goals and values in life and to link accomplishment of desired goals to values rather that to automatic thoughts and feelings. A final target of the stigma-combating process is to build a positive agenda of human connection and mutual acceptance. Techniques specific to each targeted process are described in more detail in ACT treatment and self-help manuals (Eifert and Forsyth 2005; Hayes and Smith 2005; Hayes and Strosahl 2005; Hayes et al. 1999).
ACT manual was translated and culturally adapted by study clinician. The translation and cultural adaptation was conducted according to international recommendations and ethics of worthy practice, following 10 steps offered by the International Society for Pharmaco-economics and Outcome Research (ISPOR) (Wild et al., 2005). Steps were (1) preparation, (2) forward translation, (3) reconciliation, (4) back translation, (5) back translation review, (6) harmonization, (7) cognitive debriefing, (8) review of cognitive debriefing results and finalization; (9) proofreading, and (10) final report. Reliability to the treatment protocol was assured by a combination of an initial week of training on the use of the specific model and manual, weekly supervision sessions, and quarterly training days.
Intervention Start Date
2019-04-01
Intervention End Date
2019-04-08
Primary Outcomes
Primary Outcomes (end points)
Our primary outcomes was Other as shamer scale (OAS) which is 8-item self-report questionnaire and measures intensity of shame. Other measures were the Substance Use Stigma Mechanism Scale (SU-SMS) to assess the anticipated, enacted and self stigma and consisted of 18 item.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Our secondary outcomes were Acceptance and Action Questionnaire (AAQ) 7-item scale to assess willingness to accept undesirable thoughts and feelings, while acting in a way that is congruent with values and goals, The General Health Questionnaire-12 is a widely used to measure general mental health and stress, The Quality of Life Scale, (WHO QOL-BREF) is a 26 item scale that measures several aspects of functional status, including tasks of daily living, work, social activity, family contact and daily activities. To assess the adequacy of the respondent’s perceived social support The Multidimensional Scale of Perceived Social Support, (MSPSS) a 12-item scale were used.
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
A double-blind, parallel group, randomized controlled superiority trial was conducted from January 2019 to December 2019, comparing standard treatment or treatment with acceptance and commitment therapy. The control condition was standard treatment thus we did not interfere with any other type of help that the individual might have been receiving. In effect, this was equivalent to receiving no treatment for stigma and shame. All potential participants were screened from the rehabilitation centers with a general description of the project and after conduction of interview to assess their eligibility. If participants met inclusion criteria, they were invited to complete a pre-testing sessions (T-0). Pre-testing targeted several outcome domains: Stigma (enacted, anticipated, internalized ) and shame as primary measures, general mental health, quality of life, acceptance and action questionnaire, multidimensional social support as a secondary measures. After T-0, participants were randomized into one of two groups (TAU, ACT). Following 6 hours session of training, participants underwent post-testing sessions (T-12 weeks) evaluating the same outcomes as pre-test.
Experimental Design Details
Randomization Method
computer-generated randomization schedule
Randomization Unit
Cluster Randomization was performed.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
Randomization was balanced using randomly permuted blocks of sizes six, and eight participants, and was clustered by clinical center.
Sample size: planned number of observations
65 participants
Sample size (or number of clusters) by treatment arms
65 substance users were recruited for studies from drug rehabilitation center
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
Documents
Document Name
Research design
Document Type
other
Document Description
File
Research design

MD5: 16a30c927deaa0cad2c6ea8c97605662

SHA1: c24bf2b0c072d2790b80bb8113273056d20bc80b

Uploaded At: March 18, 2020

IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Study has received IRB approval. Details not available.
IRB Approval Date
Details not available
IRB Approval Number
Details not available
IRB Name
Human research ethics committee of foundation university islamabad, rawalpindi campus
IRB Approval Date
2019-01-01
IRB Approval Number
HRECFURC/09-A/2020
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Yes
Data Collection Completion Date
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers