Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMax-Planck-Institute of Psychiatry

About this trial

This prospective, non-randomised, pre-post feasibility study evaluates CHANGE, a novel 8-session modularized cognitive behavioral group psychotherapy for young adults (18-25 years) with psychiatric disorders receiving inpatient or day-care treatment. All eligible participants (planned n=30) receive the intervention in addition to treatment-as-usual; there is no control arm. The primary aim is to assess feasibility, acceptability and appropriateness of the intervention (SMI (a German scale for feasibility), SAI (a German scale for acceptability), AIS (a German scale for appropriateness) scales; recruitment, retention, adherence and dropout rates). Secondary outcomes include perceived competence, self-efficacy (SWE), motivation (FEVER), satisfaction, quality of life (WHOQOL-BREF) and level of functioning (GAF), assessed before (T0) and after (T1) the intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >=18 years and < 26 years

Ability to provide written informed consent

Disqualifiers

Age < 18 years, age >= 26 years

Lack of ability to provide written informed consent

Severe concomitant neurological or internal medical diseases

Severe cognitive impairment (IQ < 80, severe learning disability, brain damage or pervasive developmental disorder)

Trial design

Design model

Single group

Treatments tested in this trial

  • CHANGE - modularized group psychotherapy

    Other intervention

    8-session (weekly, 75 min/session), modularized group psychotherapy comprising 4 modules: (1) transition-specific psychoeducation, (2) suicidality, (3) media/internet/gaming addiction, (4) communication. Delivered in groups of max. 12 participants by a psychiatrist/psychotherapist in training under supervision, in addition to treatment-as-usual.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CHANGE intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)

Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added.

Time frame
T1 (8 weeks after baseline)
2

Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017)

Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added.

Time frame
T1 (8 weeks after baseline)
3

Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017)

Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree).

Time frame
T1 (8 weeks after baseline)
4

Recruitment rate

number of consented participants / number of eligible patients

Time frame
T1 (8 weeks after baseline)

Secondary outcomes

1

Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)

Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)

Time frame
T0 (baseline), T1 (8 weeks after baseline)
2

Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003).

Questionnaire consisting of 24 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), item 11 was adapted.

Time frame
T0 (baseline), T1 (8 weeks after baseline)
3

Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000)

Questionnaire consisting of 26 items rated on a 5-point Likert scale with response formats varying by item (intensity, capacity, frequency, or satisfaction), item 10 was adapted.

Time frame
T0 (baseline), T1 (8 weeks after baseline)
4

Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)

Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)

Time frame
T0 (baseline), T1 (8 weeks after baseline)

Other outcomes

1

General Feedback, measured by open-ended questions, self-constructed

Questionnaire consisting of 3 open-ended free-text questions

Time frame
T1 (8 weeks after baseline)

Sponsors and contacts

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