Trial Outcomes & Findings for Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities (NCT NCT02919826)

Results Overview

Psychometric measure of emotional dysregulation: Total items 36 (range 36-180), responses ranging from 1 to 5, where 1 is almost never (0-10%), 2 is sometimes (11- 35%), 3 is about half the time (36-65%), 4 is most of the time (66-90%), and 5 is almost always (91-100%). DERS items were recoded so that higher scores in every case indicated greater difficulties in emotion regulation (i.e., greater emotion dysregulation).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Pre treatment and 12 week post treatment

Results posted on

2020-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	DBT Group Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm People in this group will receive treatment as usual
Overall Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DBT Group n=10 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm n=10 Participants People in this group will receive treatment as usual	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	8 Participants n=10 Participants	12 Participants n=20 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	2 Participants n=10 Participants	8 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Pre treatment and 12 week post treatment

Psychometric measure of emotional dysregulation: Total items 36 (range 36-180), responses ranging from 1 to 5, where 1 is almost never (0-10%), 2 is sometimes (11- 35%), 3 is about half the time (36-65%), 4 is most of the time (66-90%), and 5 is almost always (91-100%). DERS items were recoded so that higher scores in every case indicated greater difficulties in emotion regulation (i.e., greater emotion dysregulation).

Outcome measures

Outcome measures
Measure	DBT Group Intervention n=10 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm n=8 Participants People in this group will receive treatment as usual
Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)	1.4 score on a scale Standard Deviation 18.5	0.8 score on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Pre treatment and 12 week post treatment

Psychometric measure of anger dyscontrol as part of total anger scale: Total items 25 (range 25-100), responses ranging from 1 to 4, where 1 is not at all angry, 2 is a little angry, 3 is fairly angry and 4 is very angry. NAS-PI were recoded so that higher scores in every case indicated greater difficulties in anger control (i.e., greater anger dyscontrol).

Outcome measures

Outcome measures
Measure	DBT Group Intervention n=10 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm n=8 Participants People in this group will receive treatment as usual
Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)	6.4 score on a scale Standard Deviation 15.6	5.6 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Pre treatment and 12 week post treatment

Psychometric measure of psychiatric illness in individuals with intellectual disabilities: Total items 26 (range 26-78), responses ranging from 1 to 3, where 1 is no problem, 2 is problem and 3 is always a problem. REISS items were recoded so that higher scores in every case indicated greater problems with mental health issues ( i.e. psychopathology.)

Outcome measures

Outcome measures
Measure	DBT Group Intervention n=10 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm n=8 Participants People in this group will receive treatment as usual
Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)	1.8 score on a scale Standard Deviation 9.3	2.9 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Pretreatment and 12 week post treatment

Psychometric adapted measure of emotional regulation for informants. Given to caregivers to report on changes in observed emotional regulation. Total items 24 (range 24 - 96) responses ranging from 1 to 4, where 1 is never, 2 is sometimes, 3 is often and 4 is almost always. ERC items were recoded so that higher scores in every case indicated greater emotional regulation.

Outcome measures

Outcome measures
Measure	DBT Group Intervention n=10 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm n=8 Participants People in this group will receive treatment as usual
Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)	4.0 score on a scale Standard Deviation 9.9	0.5 score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: 12 week Post Treatment

Population: Following team review participants included in intervention group also belonged to control group. Institutional review board required treatment be offered to control group at end of study. Post-treatment data was collected for all participants who participated in the intervention using this measure. There was missing data (2) for treatment arm.

Adapted measure of clinical treatment change for informant: Participants were asked for perceived degree of change post group with total overall change; responses ranging from no change (identified problem got worse), to somewhat better (better but no noticeable change), to better (better but the change has not made a significant difference), to moderately better (slight improved difference) to much better (definite improvement and made a significant difference). GIC items were collapsed either into two groups: no change or change (somewhat better, better, moderately better and much better); responses were analyzed in percentages in either group.

Outcome measures

Outcome measures
Measure	DBT Group Intervention n=16 Participants Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy	Control Arm People in this group will receive treatment as usual
Global Impression of Change: Percentage of Participants Reporting Improvement	12 Participants	0 Participants

Adverse Events

DBT Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Muhammad Ayub

Queen's University

Phone: 613-549-7944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place